Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol

Priya Tikhile; Deepali Patil

doi:10.12688/f1000research.136799.1

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Study Protocol

Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol

[version 1; peer review: 2 approved with reservations, 1 not approved]

Priya Tikhile ¹, Deepali Patil¹

PUBLISHED 06 Oct 2023

Author details Author details

¹ Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Priya Tikhile
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Deepali Patil
Roles: Conceptualization, Resources, Supervision, Validation, Visualization

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Lower back pain that has lasted longer than 12 weeks is referred to as chronic lower back pain (CLBP). Lumbar extensor deterioration is a typical characteristic of CLBP. Muscular degeneration could impact proprioception along with reducing strength and endurance, which would further exacerbate concerns about balance. Along with force-matching ability, lower back muscles working together is frequently compromised in CLBP patients. The prime goals of bodily workout in administration of long-lasting lower back ache are advance muscular strength and flexibility, to re-establish injured tissues and to contribute easy engaging in daily tasks. Proprioceptive sense is reduced in CLBP patients due to mechanical alterations in their musculature. Hence, in order to develop an efficient management plan, it is crucial for patients and physiotherapists to understand the alterations that result from the shift in trunk muscular endurance in people with CLBP and how they impact the functional level. Outlined here is a proposed study aiming to evaluate the effectiveness of consecutive loop TheraBand (CLX) adjunct to proprioceptive neuromuscular facilitation (PNF) and conventional physiotherapy exercises on subjects with CLBP in a two-arm parallel superiority randomized clinical trial in reducing pain and enhancing balance. The participants will be split into two groups for equal allocation, after which the intervention CLX adjunct to PNF will be provided to one group and conventional physiotherapy exercises will be provided for another group for six weeks, a total of six days a week, for 50 minutes per day. After six weeks of intervention, the results will be assessed for pain and balance. The implementation of this physiotherapy technique in treatment could occur if the study’s hypothesis is successful in CLBP. Additionally, it will aid in lowering the incapacity in activities of daily living in those recovering from lower back pain.
CTRI registration number: CTRI/2023/05/052851

Keywords

Proprioceptive Neuromuscular Facilitation, CLX Thera band, Low back pain, Balance, Strengthening, Resistance, Disability

Corresponding author: Priya Tikhile

Competing interests: No competing interests were disclosed.

Grant information: This work is supported by an intra-mural grant from Datta Meghe Institute of Higher Education and Research.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2023 Tikhile P and Patil D. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Tikhile P and Patil D. Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1280 (https://doi.org/10.12688/f1000research.136799.1) First published: 06 Oct 2023, 12:1280 (https://doi.org/10.12688/f1000research.136799.1) Latest published: 06 Oct 2023, 12:1280 (https://doi.org/10.12688/f1000research.136799.1)

Introduction

With an incidence as high as 84%, lower back pain is a frequent musculoskeletal issue that mostly impacts adults. Lower back pain (LBP) that lasts for a minimum of 12 weeks is known as chronic lower back pain (CLBP).¹ In order to figure out the worldwide impact of low back pain, which is described as” low back pain that limits activities for a minimum of one day”.² LBP is recognised to have an impact on all affected older and younger individuals, impairing their quality of life and productivity at work.³ As a result, earlier categories of LBP that were generally acute, subacute, or chronic in character are being replaced with an increased understanding of LBP as a chronic, recurrent ailments that may follow one of numerous pathways.⁴

About 60% of Indians experience notable back pain during some period of their life.⁵ Nociceptors, which are sensors of pain, are numerous in the peripheral tissues, including muscles, tendons, ligaments, fascia, synovium, facet joints, intervertebral disc (IVD), and joint capsules. Deterioration of the aforementioned structures may trigger the nociceptive pathway, swiftly excite nociceptors, and cause a sequence of biochemical events that result in pain.⁶ It has been reported that chronic nonspecific low back pain (CNLBP) may begin with weakened or insufficient motor control in the deep trunk muscles. Postural and balance issues can result from changes in the way the mechanoreceptors interact and ailments with the paraspinal muscles in peripheral proprioceptive system.⁷

A major biomechanical definition of balance is the lack of ability to maintain the line of gravity, which is a vertical axis from the body’s centre of mass with minimal postural saying.⁸ To accomplish everyday physical activities of individuals, balance regulating and maintaining at static and dynamic positions is needed.⁹ CLBP patients exhibit more impaired balance than unaffected individuals.¹⁰ The lumbar extensors, which include the superficial erector spinae and the deep and superficial musculature, are the main muscles associated with lumbar stabilisation in specific. Lumbar extensor deconditioning is a typical characteristic of CLBP. Muscular degeneration may affect proprioception and result in strength and endurance loss, which contributes to balance dysfunction.¹¹ In persons with CLBP, trunk balancing exercises reduced disability and improved function and quality of life.¹² Exercises that increase trunk stability aid the body in maintaining its balance and equilibrium.¹³

Proprioceptive neuromuscular facilitation (PNF) makes use of the proprioceptive system and reflexes of the body to either hinder or promote muscle contraction. PNF approaches enhance a patient’s entire ability to function, including their muscular strength, muscular endurance, joint mobility, joint stability, neuromuscular control, balance, and coordination.¹⁴ Physical therapists frequently utilise PNF training when treating patients with persistent LBP because it enhances muscle performance by its movement patterns. PNF training uses spiral and diagonal directions, that are better in enhancing human performance and lessening the signs and symptoms of chronic LBP than traditional single-direction exercise programming.¹⁵ The bending and extending of the trunk are made possible by the application of rhythmical stabilisation (RS) and a combination of isotonic (COI) strategies while seated.¹⁶

Consecutive loops (CLX) are elastic bands in the form of a loop. The participants’ upper and lower limbs both wear CLX. Since CLX includes a loop-shaped gap inside the band, unlike other elastic bands, it is simple to give a holding point during band exercise not having to knot it individually, and it offers simultaneous resistance to numerous joints.¹⁷ Advantages that you don't need to fasten them to anything; you can just wind them around your hands or stabilise them on your own body.¹⁸ Utilising resistance bands improves spinal extensor stability and strength, reduces lumbar pain, and promotes good posture.¹⁹ Balance is improved as a result of strengthening exercises using a TheraBand, which also strengthens the lower extremities.²⁰ Exercise using an elastic band helps decrease joint discomfort while also enhancing balance, walking ability, flexibility, strength, mobility, and performance.²¹

In this study, we aim to test the effectiveness of CLX resistance bands adjunct to proprioceptive neuromuscular facilitation and IFT on subjects with chronic LBP in a two-arm parallel superiority randomized clinical trial (RCT), in reducing pain and enhancing balance and reducing disability in end-point results on marginal difference.

Aims and objectives

1. To assess the subjects’ pain (Visual Analogue Scale), balance (Balance Error Scoring System, Y – Balance test) due to CLBP treated with CLX resistance bands adjunct to PNF and conventional physiotherapy exercises; to evaluate their effect on reducing pain and improving balance.
2. To assess CLBP subjects’ change in disability (Modified Oswestry Low Back Pain Disability Questionnaire) when treated with CLX resistance bands adjunct to Proprioceptive Neuromuscular facilitation (PNF) and conventional physiotherapy exercises; assess if it can aid in lowering the disability in activities of daily living in overall population.
3. To assess the effectiveness of treatment with CLX resistance bands adjunct to PNF along with interferential therapy (IFT) and conventional physiotherapy exercises with IFT in reducing pain, balance and disability for the population with CLBP.

Trial design

This study will be a single-center, two-arm parallel superiority RCT.

Protocol

This is clinical trial research protocol will take place in the Outpatient Department of Ravi Nair Physiotherapy College and Acharya Vinobha Bhave Hospital Sawangi, Wardha, Maharashtra, India. After receiving the Ethical approval from the Institutional Ethical Committee of Datta Meghe Institute of Higher Education and Research. Signed informed participant consent will be obtained, and participants will be selected throughout the region in accordance with the study’s inclusion and exclusion criteria. Participants will be randomly allocated to two groups: Group A (CLX adjunct to PNF and IFT) and Group B (Conventional Physiotherapy exercises and IFT) in a 1:1 allocation. For participant allocation, a randomization approach employing a computer-generated will be used. The allocation blinding mechanism used will be sequentially numbered, opaque, sealed envelopes. Cut-off values at the baseline will be utilised to select participants for the open-label study while taking into account inclusion and exclusion criteria. The interventional group will receive CLX resistance band adjunct to PNF with IFT therapy and the control group will receive conventional physiotherapy exercises with IFT therapy, for reduction in pain and improvement of balance and lowering of disability. Subjects will be enrolled and evaluated at several points throughout the study, including visit 1 for subject enrolment and subject evaluation. Baseline and follow-up visits at six weeks and three weeks after treatment will be carried out, where primary as well as secondary variables will be assessed. The study design is depicted in Figure 1.

Figure 1. Showing consort diagram of the study procedure.

Inclusion criteria

Both male and female patients, between the ages of 20 and 50, having non-specific CLBP persisting longer than three months, LBP with non-specific nature (mechanical) i.e. without identifiable specific anatomical or neurophysiological causative factors, will be included.

Exclusion criteria

Individuals with nerve root pain signs, patients with lumbar canal stenosis, prolapsed intervertebral disc (PIVD), scoliosis, past spinal repair, spondylosis and spondylolisthesis will be exluded. Patients with a history of any vertebral fractures, systemic disorders - tuberculosis of spine or rheumatoid arthritis will be excluded as well.

Interventions

Experimental group

The exercise regimen will be carried out in five different positions: lying down, long sitting, kneeling, kneeling to stand, and standing. PNF pattern will be administered in each position to both the upper and lower limbs, combining the D1 and D2 patterns given in Table 1. The subjects will wear CLX consecutive loops (CLX, TheraBand), around the wrists and ankles, as they perform the PNF pattern exercise in five positions.¹⁷ For every position, the patient will exercise in a CLX + PNF pattern for five minutes and then take a 1-minute break. Table 1 shows the PNF pattern for upper limb and lower limb regimen.

Table 1. Table showing PNF pattern for upper limb and lower limb regimen.

Pattern

Shoulder

Hip

D1
D1 F
D1 E

• Flexion, adduction, external rotation
• Extension, abduction, internal rotation

• Flexion, adduction, external rotation
• Extension, abduction, internal rotation

D2
D2 F
D2 E

• Flexion, abduction, external rotation
• Extension, adduction, internal rotation

• Flexion, abduction, internal rotation
• Extension, adduction, external rotation

Control group

For each session, the patients will undergo three sets of 15 repetitions, with a 30-second break between every set. Following the 15 repeats, there will be a 60-second break. The treatment programme will be separated into three parts, and the individuals’ performance will determine how far along in each step the training should go.²²

1) The participant will practise alternate trunk flexor and extensor isometric contractions while providing maximum force. The physiotherapist will conduct the treatment for 10 seconds while the patient is seated.²²
2) The participant will focus on performing alternate isometric contractions of the trunk agonistic muscles, including a 5s hold resisted concentric contraction of the trunk flexors while bending forward, a 5s hold resisted eccentric contraction of the trunk flexors while returning to the neutral position of the trunk, and a 5s hold resisted isometric contraction of the trunk muscles while in the neutral position. The trunk’s backward bending will be accomplished using a similar technique.²²
3) The subjects will alternatively perform the chop and lift movement patterns in diagonal and spiral directions for ten seconds in order to train their upper extremities. The physiotherapist will provide the most resistance.²²

Both groups will receive IFT

Patients were instructed to lie down in a prone position with their lower backs exposed for this, which involves IFT over that area. An automated vector, two intersecting channels, four electrodes, and a rectangular stimulus 1/1 will also be employed. Carbon-impregnated silicone rubber and flexible electrodes will be put using an electroconductive gel and fastened by a sticky tape in a crossing arrangement at the level of the first and fifth lumbar vertebrae after washing the skin with wiping alcohol to ensure proper electrical connection.²³ Treatment variables will include: an alternating current, a sinusoidal impulse, an impulse duration of 100s, a basic frequency of 4000 Hz, an alternating frequency of 50 to 100 Hz, an individual dose (the physiotherapist will raise the intensity over time throughout treatment to preserve the intended senses until a distinct sense for the passing current was felt), and a 20-minute treatment time for each patient.²⁴

Considerations for terminating or changing the assigned treatments in a particular trial were to stop right away if the patient had any nausea or dizziness-related complaints.

Ouctomes

Primary outcome

1) Change in Visual Analogue Scale (VAS): The VAS, which is frequently employed in a variety of adult groups, is a single-dimension scale for measuring the severity of pain. A line, typically 10 cm long and in accordance with two word indicators, one for every extreme, makes up the continuous pain VAS. The most popular anchor points for the pain intensity scale are “no pain” (scoring = 0) as well as “worst possible pain” or “pain as bad as could be” (scoring = 100). The following with pain VAS cut points were suggested: no pain (0 – 4 mm), mild pain (5– 44mm), moderate pain (45–74 mm), and severe pain (75,100 mm). Test–retest reliability has been shown to be good (r = 0.94, P < 0.001) and validity was 0.99.²⁵
2) Change in Balance Error Scoring System: The Balance Error Scoring System (BESS) is a widely used clinical balance examination that is standardised. Three 20-second stances (double leg, single leg, tandem) are performed with closed eyes and hands over the hips on a hard and foamy surface. Every 20-second attempt includes a tally of errors. Three postures are evaluated by BESS. It consists of the tandem stance, one-leg stance, and two-leg stance, and it is measured in the same way as on level ground, but on an uneven surface. The exam has a maximum score of 60 points, therefore the better the participant’s capacity to balance, the lesser the total score. The maximum error score for each stance is 10 points, and the scores for all stances are added together to determine the overall result. The inter-tester reliability was excellent 0.81 (CI 0.67–0.89).²⁶
3) Change in Y balance test (YBT): The YBT is a lightweight, affordable instrument used for assessing rehabilitation process’ efficiency, coordination, and balance. In order to extend the second lower extremity as much as possible in the anterior, posterolateral, and posteromedial directions, each individual must have one leg in the centre of the three-segmented marking on the flooring. Whilst keeping their balance while standing, they will calculate the length from that point in which the toe of their extended foot is. Each foot’s measurement of the distance across the three directions will evolve into a standard score for evaluation. With intraclass correlation values in the range of 0.99 to 1.0, the YBT showed excellent inter-rater reliability.²⁷

Secondary outcome

1. Change in Modified Oswestry Low Back Pain Disability Questionnaire: The questionnaire consists of 10 questions that span a range of activities. Every aspect is given a score ranging from 0 to 5, with higher scores indicating greater disability. Before the overall score is converted to a percentile, it is multiplied by two. For rating, a maximum score of 5 may be achieved for each section: Upon marking the first sentence, the component score is equal to 0. If the final sentence is indicated it equals 5.²⁸

Sample size calculation

Sample size was calculated using the mean difference formula:

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Considering primary variable:- Balance Error scoring System (BESS) to find the effect of looped elastic band CLX and PNF (Experimental group).

Mean ± standard deviation (Pre) result on BESS for experimental group = 28.37 ± 6.36.

Mean ± standard (Post) result on BESS for Experimental group = 12.87 ± 3.83.¹⁷

Difference in mean = 15.50

Pooled standard deviation = (6.36+3.83)/2 = 5.095

Considering clinically relevant superiority = 30% = (15.50×30)/100 = 4.65

N1 = 2 \times [(1.96 + 1.28) \times (5.095) 2] / (4.65) 2 = 26

Assumptions

Z_{α} = 1.96 at 5 % error

α = Type I error at 5 %

Z_{β} = 1.28 (1 - β) = Power at 90 %

σ = Standard deviation

Total samples required = 26 per group.

Considering 20% drop out = 4

Total sample size required = 60 (30 per group)

Assumptions

Z_{α} = 1.96

α = Type I error at 5 %

Z_{β} = 1.28 (1 - β) = Power at 90 %

σ = Standard deviation

Reference article: “Effect of CLX training combined with PNF pattern on balance ability”, Journal of Korean Physical therapy Science, Ji-hoon Jung et al. (2019).¹⁷

Discussion

The main aim of this study will be to find out how CLX resistance bands adjunct to PNF and conventional physiotherapy exercises in decreasing pain and improving balance in CLBP patients.

NLBP relates to LBP that is not caused by a known condition, such as nerve root pain or severe spinal pathologies like infection, tumour, osteoporosis, rheumatoid arthritis, fracture, or inflammation.²⁹ NLBP affects 80% of people at some point in their lifetime.³⁰ Numerous medical, psychological, social, and economic issues affect patients when persistent LBP is highly prevalent. Compared to individuals with LBP, individuals with chronic pain have a higher pain score on the VAS.³¹ People with chronic NLBP are significantly more likely to have a balance disorder.⁹

Clinical practise recommendations state that primary care clinicians should also promote non-pharmacological LBP treatment such as patient education, physical activity, and manual therapies.³² The PNF pattern in conjunction with CLX exercise have been shown to improve the normal adult’s ability to balance and performing the functional mobility of the lower extremity.¹⁷ Conventional physiotherapy exercises produce the most force possible while exerting the least amount of shearing and compressive stresses during the functional motions.²⁹ Patient recovery also seems to be dependent on compliance to the exercise programme.³³

Forman et al. (2021) in his research article”THERABAND CLX gold reduces knee-width index and range of motion during overhead, barbell squatting barbell squatting”, found that muscle activation at all seven bilateral locations remained constant when overhead squatting with the CLX gold band.³⁴ Kofotolis et al. (2020) (“Effects of Two 4-Week Proprioceptive Neuromuscular Facilitation Program on Muscle Endurance, Flexibility, and Functional Performance in Women With Chronic Low Back Pain”), reported that applying a four-week RST and COI PNF program improved muscle endurance in people with CLBP by 23.6% to 81%.³⁵

Physical therapists frequently utilise PNF training using spiral and diagonal directions, which are better in relieving LBP.¹⁵ When PNF exercises are carried out properly, the patient integrates them into their everyday movements, correcting poor postures and habits that cause chronic muscle strain, soreness, stress, and at eventually injury. Additionally, their muscle spasms and pain will significantly decrease and core strengthening demonstrates the muscle control required to keep the lumbar spine functionally stable. Strengthening the core helps prevent and treat a variety of lumbar spine and musculoskeletal diseases, because it functions as a muscle corset to support the body and spine without as well as with limb movement.³⁶

Finally, this study aims to investigate how a session of CLX resistance band training with PNF and conventional physiotherapy exercises impacts the pain and balance of CLBP patients.

Analysis

The results will be tabularized and analysed statistically; data from outcome variables will be tested for normal distribution for the mean and standard deviation (SD). Median statistics will be utilized for finding skewed distributions and interquartile ranges (IQR). Frequency and percentages for binary and categorical variables will be tabulated for descriptive statistics. The inferential statistics will be analysed as per the description given below. Free R software will be used for all statistical analyses.

Primary outcome

For comparing two groups, inferential statistics will be used for measuring the score (active treatment versus control treatment) of their mean change in primary variable (VAS, BESS, Y- Balance test) between baseline and six weeks. An independent t-test will then be used. The responses of the subjects will be evaluated with regard to of the main variable’s variation from baseline to the timeframe measured throughout the project (visit 1 and at six weeks following the conclusion of the intervention). For research participants, random effects will be generalized for study subjects, and fixed effects will be analysed by considering treatment group and visit number.

95% confidence interval (CI), the effect size over the mean change difference on the major variable from baseline to endline visit at six weeks, will be assessed.

Primary end point (description)

In order to estimate the disparity in effect size among the active and control groups, secondary outcomes (MODQ) will be examined in accordance with the linear mixed model effect. If the data has a normal distribution, a t-test (Unpaired) will be used to determine if a difference is significant among means between two groups. If the data is non-normally distributed, transformation of the data will be done using mathematical methods to achieve normal distribution. Alternative non-parametric tests (Chi-square, Mann-Whitney U, and Wilcoxon test) will be utilised if the data across the main variables still exhibit non-normal distribution.

Dissemination

We are planning to publish the results in an indexed journal and present the study in National Conference Proceedings.

Study status

The recruitment of participants has not started yet.

Ethical considerations

Institutional Ethical Clearance has been obtained on 21/03/2023 (DMIHER (DU)/IEC/2023/805). CTRI Registration was obtained on 18/5/2023.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for“Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol”, https://doi.org/10.5281/zenodo.7988643.³⁷

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

The authors would like to acknowledge Mr. Laxmikant Umate and Mr. Manoj Patil who helped with sample size calculation and data analysis planning.

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Author details Author details

¹ Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Priya Tikhile
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Deepali Patil
Roles: Conceptualization, Resources, Supervision, Validation, Visualization

Competing interests

No competing interests were disclosed.

Grant information

This work is supported by an intra-mural grant from Datta Meghe Institute of Higher Education and Research.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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version 1

Published: 06 Oct 2023, 12:1280

https://doi.org/10.12688/f1000research.136799.1

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© 2023 Tikhile P and Patil D. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Tikhile P and Patil D. Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1280 (https://doi.org/10.12688/f1000research.136799.1)

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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Version 1

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PUBLISHED 06 Oct 2023

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Reviewer Report 07 Oct 2024

Vinodhkumar Ramalingam, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Chennai, India

Approved with Reservations

https://doi.org/10.5256/f1000research.149944.r325111

The authors aim to evaluate the effectiveness of consecutive loop TheraBand (CLX) adjunct to proprioceptive neuromuscular facilitation (PNF) and conventional physiotherapy exercises on subjects with CLBP with pain and balance as outcome measures. Since low back pain is common among ... Continue reading

The authors aim to evaluate the effectiveness of consecutive loop TheraBand (CLX) adjunct to proprioceptive neuromuscular facilitation (PNF) and conventional physiotherapy exercises on subjects with CLBP with pain and balance as outcome measures. Since low back pain is common among young adults, this study may provide the effect of the interventions.
The population age range of 20 and 50 years is considered a wider range, which required literature support. In addition, excluding other inflammatory conditions (ankylosis spondylitis) and spinal stenosis which reduces bias in participant enrolment.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Musculoskeletal disorders, ankle injury and sports rehabilitation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 01 Oct 2024

Y. Ravi shankar Reddy, Program of Physical Therapy, Department of Medical Rehabilitation Sciences, King Khalid University, Abha, Saudi Arabia

Approved with Reservations

https://doi.org/10.5256/f1000research.149944.r325112

Introduction:
The introduction provides a comprehensive overview of chronic low back pain (CLBP) and its significant impact on individuals worldwide. It effectively establishes the rationale for the study, highlighting the prevalence and the multifaceted challenges faced by patients ... Continue reading

Introduction:
The introduction provides a comprehensive overview of chronic low back pain (CLBP) and its significant impact on individuals worldwide. It effectively establishes the rationale for the study, highlighting the prevalence and the multifaceted challenges faced by patients with non-specific low back pain (NLBP). The inclusion of statistical data on prevalence and associated conditions strengthens the context. To enhance clarity, consider integrating more recent statistics or regional data if available, ensuring the relevance and timeliness of the information. Additionally, emphasizing the specific gaps in current treatment modalities that the proposed study aims to address would further solidify the importance of this research.

Objectives:
The objectives are clearly stated, focusing on investigating the effects of CLX resistance bands adjunct to PNF and conventional physiotherapy exercises on pain reduction and balance improvement in CLBP patients. However, to enhance specificity, consider detailing the primary and secondary outcomes explicitly. For instance, explicitly mention the specific pain scales (e.g., VAS) and balance tests (e.g., Y-Balance Test) that will be used to measure outcomes. This will provide clarity on the study's endpoints and facilitate reproducibility.

Methods:
The methods section provides a detailed outline of the study design, including participant selection criteria, intervention protocols, and outcome measures. The integration of specific references to studies supporting the efficacy of CLX bands and PNF in CLBP treatment strengthens the rationale for the chosen interventions. To improve comprehensibility, consider outlining the specific training protocols for CLX bands and PNF exercises in a step-by-step format. This would aid in replicability and ensure consistency across study sites. Additionally, specifying the duration and frequency of intervention sessions would provide crucial details for understanding participant engagement and adherence.

Statistical Analysis:
The statistical analysis plan is well-defined, outlining the methods for data handling, normality testing, and inferential statistics. The intention to use Free R software for statistical analyses is appropriate and aligns with current practices in clinical research. To enhance clarity, consider providing examples of specific statistical tests that will be employed for each type of data (e.g., t-tests for normally distributed data, Mann-Whitney U test for non-parametric data). This would assist readers in understanding the rationale behind the chosen analytical approach and ensure transparency in data interpretation.

Ethical Considerations:
The ethical considerations section appropriately mentions institutional ethical clearance and CTRI registration, ensuring compliance with ethical standards. To provide a more comprehensive view, consider briefly discussing potential risks associated with the interventions (e.g., muscle strain from CLX bands, fatigue from exercise protocols) and how these will be mitigated. This would demonstrate a thorough consideration of participant safety and ethical integrity throughout the study.

Dissemination and Study Status:
The plans for disseminating study results in an indexed journal and national conference proceedings are clearly outlined, highlighting the commitment to sharing findings with the scientific community. To enhance this section, consider briefly discussing the anticipated timeline for manuscript submission and conference presentation, if available. Additionally, providing insights into any planned collaborations or partnerships for knowledge translation would underscore the study's potential impact on clinical practice and policy.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Rehabilitation; Physical Therapy; Sports injuries

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 28 Sep 2024

Prem Venkatesan, Department of Physiotherapy, Manipal Academy of Higher Education, Manipal, Karnataka, India

Not Approved

https://doi.org/10.5256/f1000research.149944.r325114

Abstract

Needs more clarity

Aims and Objectives

It is unclear that what the study is aiming to, to correlate or associate or find the effect.

Abstract

Needs more clarity

Aims and Objectives

It is unclear that what the study is aiming to, to correlate or associate or find the effect.
Since it is an RCT, assessment will be very vague term to define the aim of the study.

Introduction:
What is the current evidence of PNF in chronic low back pain? Further what is the need to conduct study in combination with elastic bands?
There is huge amount of research available, introduction mentions single reference!
Justification is needed in line with pathophysiology of chronic low back pain, because each treatment alone itself will have an effect.
Why only PNF patterns involving diagonal and spiral movements? Why not patterns involving pelvis, lumbar and abdominals?
Why only rhythmical stabilization (RS) and a combination of isotonic (COI)? What is the justification to choose two techniques, what about other techniques?
Explain the mechanism how PNF techniques improves balance
What is the evidence of IFT in chronic low back and need to add in both groups
What is the evidence of conventional group and its justification\
There is lack of rationale and flow in the introduction and hypothesis is unclear
Protocol

When the main aim of the study is to find the effect of TheraBand based exercise and PNF exercise on balance, why was it not considered to provide the other group a similar treatment or a contrasting treatment to find the real effect. The current protocol may lead to a biased result.
Why the outcomes are assessed at the 3^rd week also, Will the data be used for any analysis? If the intermediate data will be considered for the regular analysis, there might be chances for change in the statistical analysis.

Interventions

Whether the intervention group will be receiving the resistance exercises irrespective of the pain intensity, as some of subjects may not cop up with resistance exercises. Any basic exercises will be taught?
The details regarding the IFT treatment is missing in the intervention group. Although it is mentioned in the later part, it will be better to be mentioned in the intervention group protocol also.
How will be the resistance provided in the control group (3 point of the treatment)
Mention blinding of the study
What are the diagnostic criteria for non-specific low back pain
Why exercise in experimental group given in five different positions
Mention the repetitions for the experimental group
Why IFT placed at the level of the first and fifth lumbar vertebrae

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Cardiopulmonary and musculoskeletal rehabilitation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

CITE

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VERSION 1 PUBLISHED 06 Oct 2023

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Version 1 06 Oct 23	read	read	read

Prem Venkatesan, Manipal Academy of Higher Education, Manipal, India
Y. Ravi shankar Reddy, King Khalid University, Abha, Saudi Arabia
Vinodhkumar Ramalingam, Saveetha Institute of Medical and Technical Sciences, Chennai, India

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Reviewer Report

1 Views

07 Oct 2024 | for Version 1

Vinodhkumar Ramalingam, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Chennai, India

1 Views Cite this report Responses(0)

Approved With Reservations

The authors aim to evaluate the effectiveness of consecutive loop TheraBand (CLX) adjunct to proprioceptive neuromuscular facilitation (PNF) and conventional physiotherapy exercises on subjects with CLBP with pain and balance as outcome measures. Since low back pain is common among young adults, this study may provide the effect of the interventions.
The population age range of 20 and 50 years is considered a wider range, which required literature support. In addition, excluding other inflammatory conditions (ankylosis spondylitis) and spinal stenosis which reduces bias in participant enrolment.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Musculoskeletal disorders, ankle injury and sports rehabilitation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

1 Views

01 Oct 2024 | for Version 1

Y. Ravi shankar Reddy, Program of Physical Therapy, Department of Medical Rehabilitation Sciences, King Khalid University, Abha, Saudi Arabia

1 Views Cite this report Responses(0)

Approved With Reservations

Introduction:
The introduction provides a comprehensive overview of chronic low back pain (CLBP) and its significant impact on individuals worldwide. It effectively establishes the rationale for the study, highlighting the prevalence and the multifaceted challenges faced by patients with non-specific low back pain (NLBP). The inclusion of statistical data on prevalence and associated conditions strengthens the context. To enhance clarity, consider integrating more recent statistics or regional data if available, ensuring the relevance and timeliness of the information. Additionally, emphasizing the specific gaps in current treatment modalities that the proposed study aims to address would further solidify the importance of this research.

Objectives:
The objectives are clearly stated, focusing on investigating the effects of CLX resistance bands adjunct to PNF and conventional physiotherapy exercises on pain reduction and balance improvement in CLBP patients. However, to enhance specificity, consider detailing the primary and secondary outcomes explicitly. For instance, explicitly mention the specific pain scales (e.g., VAS) and balance tests (e.g., Y-Balance Test) that will be used to measure outcomes. This will provide clarity on the study's endpoints and facilitate reproducibility.

Methods:
The methods section provides a detailed outline of the study design, including participant selection criteria, intervention protocols, and outcome measures. The integration of specific references to studies supporting the efficacy of CLX bands and PNF in CLBP treatment strengthens the rationale for the chosen interventions. To improve comprehensibility, consider outlining the specific training protocols for CLX bands and PNF exercises in a step-by-step format. This would aid in replicability and ensure consistency across study sites. Additionally, specifying the duration and frequency of intervention sessions would provide crucial details for understanding participant engagement and adherence.

Statistical Analysis:
The statistical analysis plan is well-defined, outlining the methods for data handling, normality testing, and inferential statistics. The intention to use Free R software for statistical analyses is appropriate and aligns with current practices in clinical research. To enhance clarity, consider providing examples of specific statistical tests that will be employed for each type of data (e.g., t-tests for normally distributed data, Mann-Whitney U test for non-parametric data). This would assist readers in understanding the rationale behind the chosen analytical approach and ensure transparency in data interpretation.

Ethical Considerations:
The ethical considerations section appropriately mentions institutional ethical clearance and CTRI registration, ensuring compliance with ethical standards. To provide a more comprehensive view, consider briefly discussing potential risks associated with the interventions (e.g., muscle strain from CLX bands, fatigue from exercise protocols) and how these will be mitigated. This would demonstrate a thorough consideration of participant safety and ethical integrity throughout the study.

Dissemination and Study Status:
The plans for disseminating study results in an indexed journal and national conference proceedings are clearly outlined, highlighting the commitment to sharing findings with the scientific community. To enhance this section, consider briefly discussing the anticipated timeline for manuscript submission and conference presentation, if available. Additionally, providing insights into any planned collaborations or partnerships for knowledge translation would underscore the study's potential impact on clinical practice and policy.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Rehabilitation; Physical Therapy; Sports injuries

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

3 Views

28 Sep 2024 | for Version 1

Prem Venkatesan, Department of Physiotherapy, Manipal Academy of Higher Education, Manipal, Karnataka, India

3 Views Cite this report Responses(0)

Not Approved

Abstract

Needs more clarity

Aims and Objectives

It is unclear that what the study is aiming to, to correlate or associate or find the effect.
Since it is an RCT, assessment will be very vague term to define the aim of the study.

Introduction:
What is the current evidence of PNF in chronic low back pain? Further what is the need to conduct study in combination with elastic bands?
There is huge amount of research available, introduction mentions single reference!
Justification is needed in line with pathophysiology of chronic low back pain, because each treatment alone itself will have an effect.
Why only PNF patterns involving diagonal and spiral movements? Why not patterns involving pelvis, lumbar and abdominals?
Why only rhythmical stabilization (RS) and a combination of isotonic (COI)? What is the justification to choose two techniques, what about other techniques?
Explain the mechanism how PNF techniques improves balance
What is the evidence of IFT in chronic low back and need to add in both groups
What is the evidence of conventional group and its justification\
There is lack of rationale and flow in the introduction and hypothesis is unclear
Protocol

When the main aim of the study is to find the effect of TheraBand based exercise and PNF exercise on balance, why was it not considered to provide the other group a similar treatment or a contrasting treatment to find the real effect. The current protocol may lead to a biased result.
Why the outcomes are assessed at the 3^rd week also, Will the data be used for any analysis? If the intermediate data will be considered for the regular analysis, there might be chances for change in the statistical analysis.

Interventions

Whether the intervention group will be receiving the resistance exercises irrespective of the pain intensity, as some of subjects may not cop up with resistance exercises. Any basic exercises will be taught?
The details regarding the IFT treatment is missing in the intervention group. Although it is mentioned in the later part, it will be better to be mentioned in the intervention group protocol also.
How will be the resistance provided in the control group (3 point of the treatment)
Mention blinding of the study
What are the diagnostic criteria for non-specific low back pain
Why exercise in experimental group given in five different positions
Mention the repetitions for the experimental group
Why IFT placed at the level of the first and fifth lumbar vertebrae

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Cardiopulmonary and musculoskeletal rehabilitation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

Responses (0)

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[14] 14. Pourahmadi M, Sahebalam M, Bagheri R: Effectiveness of Proprioceptive Neuromuscular Facilitation on Pain Intensity and Functional Disability in Patients with Low Back Pain: A Systematic Review and Meta-Analysis. Arch. Bone Jt. Surg. 2020 Jul; 8(4): 479–501. PubMed Abstract | Publisher Full Text

[15] 15. Gao P, Tang F, Liu W, et al.: The effects of proprioceptive neuromuscular facilitation in treating chronic low back pain: A systematic review and meta-analysis. J. Back Musculoskelet. Rehabil. 2022; 35(1): 21–33. Publisher Full Text

[16] 16. Panjaitan L, Susy N, Manik J: Proprioceptive neuromuscular facilitation approach for low back pain: A review study. J. Sport Exerc. Health. 2022 May 27; 6: 82–87. Publisher Full Text

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[20] 20. Yu W, An C, Kang H: Effects of Resistance Exercise Using Thera-band on Balance of Elderly Adults: A Randomized Controlled Trial. J. Phys. Ther. Sci. 2013 Nov; 25(11): 1471–1473. PubMed Abstract | Publisher Full Text | Free Full Text

[21] 21. Vafaeenasab MR, Kuchakinejad Meybodi N, Fallah HR, et al.: The Effect of Lower Limb Resistance Exercise with Elastic Band on Balance, Walking Speed, and Muscle Strength in Elderly Women.2019 Jul 2 [cited 2023 Feb 24]. Reference Source

[22] 22. Areeudomwong P, Buttagat V: Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial. Braz. J. Phys. Ther. 2019 Sep; 23(5): 428–436. PubMed Abstract | Publisher Full Text | Free Full Text

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Effect of CLX training adjunct to PNF and conventional physiotherapy on pain and balance in patients with chronic lower back pain: A randomised clinical trial protocol

Abstract

Keywords

Introduction

Aims and objectives

Trial design

Protocol

Figure 1. Showing consort diagram of the study procedure.

Inclusion criteria

Exclusion criteria

Interventions

Table 1. Table showing PNF pattern for upper limb and lower limb regimen.

Both groups will receive IFT

Ouctomes

Sample size calculation

Discussion

Analysis

Primary outcome

Primary end point (description)

Dissemination

Study status

Ethical considerations

Data availability

Underlying data

Reporting guidelines

Acknowledgements

References

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