Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol

Aditi N. Nagore; Subrat Samal

doi:10.12688/f1000research.138130.1

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Study Protocol

Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol

[version 1; peer review: 1 approved]

Aditi N. Nagore ¹, Subrat Samal¹

PUBLISHED 20 Sep 2023

Author details Author details

¹ Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442004, India

Aditi N. Nagore
Roles: Conceptualization, Writing – Original Draft Preparation

Subrat Samal
Roles: Supervision, Validation

OPEN PEER REVIEW

REVIEWER STATUS

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

Abstract

Background: Tennis elbow, also known as lateral epicondylitis, is a painful condition characterized by irritation of the tendons that link the forearm muscles on the outside of the elbow, which can result from using the elbow too much. Active Release Technique (ART) is defined as a hands-on approach that manages cases to enable the identification and treatment of soft tissue injuries. Through the removal of fibrosis and adhesions that can develop in tissues as a result of overload from frequent use, the aim of ART, a soft tissue treatment, is to lessen tissue stress. Deep transverse friction (DTF) and Mill's manipulation, which are used shortly after DTF, have been used by Cyriax and Cyriax to successfully treat tennis elbow. ART and Cyriax techniques have shown promise for lateral epicondylitis sufferers. There hasn't yet been any research comparing these two approaches for participants with lateral epicondylitis. The aim is to examine the efficiency of ART with the Cyriax technique on lateral epicondylitis pain, strength, and function.
Methods: A total number of 60 participants will be included as per the inclusion criteria and then they will be further divided into 30 in each group. The physiotherapy intervention will be given to Groups A (ART) and Group B (Cyriax technique) along with conventional 12 sessions spread across four weeks, three times per week. Each patient will be evaluated during and after treatment on the baseline and after four weeks using the Visual Analogue Scale (VAS), hand grip strength dynamometer, and Patient-rated Tennis Elbow Evaluation (PRTEE) scale.
Conclusions: This physiotherapy intervention could be used in the treatment of lateral epicondylitis if our study's hypothesis is found to be accurate.
Registration: CTRI (CTRI/2023/06/053660; 08/06/2023).

Keywords

Tennis Elbow, Active Release Technique, Cyriax Technique, Lateral Epicondylitis, Conventional therapy, Visual Analogue Scale, Hand grip strength dynamometer, and Patient rated tennis elbow scale

Corresponding author: Aditi N. Nagore

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Nagore AN and Samal S. 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: Nagore AN and Samal S. Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1175 (https://doi.org/10.12688/f1000research.138130.1) First published: 20 Sep 2023, 12:1175 (https://doi.org/10.12688/f1000research.138130.1) Latest published: 20 Sep 2023, 12:1175 (https://doi.org/10.12688/f1000research.138130.1)

Introduction

The most prevalent elbow overuse ailment is called lateral epicondylitis, also referred to as tennis elbow, and more recently as lateral elbow (or epicondyle) tendinopathy (LET). Using a computer, moving heavy objects, pronating and supinating the forearms, and vibrating frequently are all common repetitive upper limb activities that cause it.¹ Fibroblasts, vascular hyperalgesia, and disorganized collagen are histological indicators of tendon deterioration. Normally, the discomfort is localised to the epicondyle, but in more extreme situations, it may extend to the wrist and shoulder. Pressure on the epicondyle, resistance to wrist extension, and strain of the epicondyle muscles are the usual causes of it. The most prevalent age range is 35 to 54 years old, with an estimated incidence of 40% and a frequency of 1% to 3% in the general population.² The tennis elbow is brought on by pain-inducing tendon injury to the wrist’s short radial extensor on the lateral side. Relevant risk factors include overuse, repeated motions, improper training, misalignment, flexibility problems, aging, poor circulation, muscle weakness or imbalance, and mental variables.³

Simple tests that would elicit discomfort, tenderness over the lateral epicondyle facet on touch, resistant wrist extension, resisted middle finger extension, and passive wrist motion could be used to diagnose tennis elbow flexion. First, Mill’s test is a special test performed to identify lateral epicondylitis. The examiner passively pronates the patient’s forearm, fully extends the elbow, and fully flexes the wrist while palpating the lateral epicondyle. Pain above the lateral epicondyle of the humerus and a second Cozen’s test are signs of a positive test. The examiner’s thumb, which is resting on the patient’s lateral epicondyle, is stabilizing the patient’s elbow. The patient is then instructed to pronate their forearm, extend their wrist radially, and create a fist as the examiner resists them. Sudden, severe pain in the lateral epicondyle of the humerus is indicative of positive information. To determine the source of discomfort, the epicondyle can be felt, and third, resisted. The middle finger extension test stresses the extensor digitorum muscle and tendon by resisting the extension of the third finger of the hand distal to the proximal interphalangeal joint. Pain across the lateral epicondyle of the humerus signifies a positive test.⁴

The Active Release Technique (ART) is a manual therapy used to eliminate scar tissue, which can cause pain, stiffness, weakness in the muscles, and other aberrant feelings like mechanical dysfunction in the muscles and the restoration of soft tissue function.⁵ According to its description, ART is a hands-on approach that handles the cases to make it possible to recognise and cure soft tissue injuries. The foundation of ART is the concept of recognizing and treating cumulative damage disease (CID). The patient actively changes the targeted area’s posture from a shorter to a longer one as the physical therapist repeatedly administers deep manual pressure strokes to the unpleasant and painful location.⁶ Deep transverse friction (DTF) and Mill’s manipulation, which are used immediately after DTF, have both been used to successfully treat tennis elbow by Cyriax and Cyriax. It is necessary for the two components of Cyriax intervention to be present and combined in the right order. The most well-known kind of physical therapy is referred to as Mill’s manipulation, and it entails pushing with a small-amplitude, high-velocity force while keeping the wrist and hand in a flexed position near the end of the elbow extension.⁷ This study’s objective is to examine the effectiveness of the Cyriax technique and ART on participants experiencing subacute lateral epicondylitis who are experiencing discomfort, weakness, and functional impairment.

Aim and objectives

1. To study the effect of ART along with conventional therapy for pain visual analogue scale (VAS), for grip strength (hand grip strength dynamometer) and for functional performance (Patient-rated Tennis Elbow Evaluation (PRTEE) scale) in individuals with lateral epicondylitis.
2. To study the effect of Cyriax technique along with conventional therapy for pain VAS, for grip strength (hand grip strength dynamometer) and for functional performance (PRTEE) in individuals with lateral epicondylitis.
3. To compare the effect of ART and Cyriax technique along with conventional therapy for pain VAS, for grip strength (hand grip strength dynamometer) and for functional performance (PRTEE) in individuals with lateral epicondylitis.

Trial design

Single centre, two arm parallel, open label, randomized clinical trial.

Protocol

The model consent form, data collection form and schedule of enrolment, interventions and assessments can be found as Extended data.²¹ This study protocol adheres to the SPIRIT checklist.²² After getting approval from the Datta Meghe Institute of Higher Education & Research’s institutional ethics committee participants in this study will be enrolled from the Physiotherapy Outpatient Department (OPD) of Acharya Vinoba Bhave Rural Hospital Sawangi, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University) Meghe, Wardha, Maharashtra, and written informed consent will be obtained.

The study’s inclusion and exclusion criteria will be applied to the population of the region. They will be divided into two groups, Groups A and B. There will be 30 subjects in each group. Group A will receive ART along with conventional treatment that will last for 30 minutes. The participants in group B will receive Cyriax technique for a duration of 30 minutes along with conventional treatment. As part of the inclusion procedure for the study, subjects will be recruited according to inclusion criteria and evaluated according to the assessment and outcome measures. For subject allocation, a computer-generated random number system will be used for the randomization process utilizing the simple envelope method. In this trial, there will be no blinding. The allocation will be generated by the lead investigator, who will also enrol individuals and allocate them to interventions. The project will be overseen by a departmental committee comprised of the Post Graduate (PG), Guide, Head of Department (HOD), Principal of the Ravi Nair Physiotherapy College (RNPC), and a member of the Research Guidance Cell. We will ensure that the patients strictly follow the recommended treatment plan through routine treatment sessions. Individuals will receive counselling or phone reminders about their therapy appointments as necessary. Each patient will be assessed pre and post-treatment on the baseline and after four weeks using the VAS, hand grip strength dynamometer, and PRTEE. The study design is visualized in Figure 1.

Figure 1. Flowchart of procedure.

Eligibility criteria

Inclusion criteria

1. Both male and female patients between the age group of 18 to 45 years old.
2. Patients with pain that has lasted more than 3 months.
3. Patients that have been diagnosed with lateral epicondylitis.
4. Those who intend to take part in the study.

Exclusion criteria

1. Patients with the history of cervical and upper limb injuries.
2. Patients who have undergone any procedure involving the cervical area and an upper limb.
3. Patients with any regional infections.
4. Patients with any localized cancer.
5. Patients with lateral epicondylitis that is acute in nature.
6. Patients with cervical radiculopathy.
7. Patients with a recent history of steroidal infusion.

Interventions

Conventional treatment

Description

After identifying the area of pain, the ultrasound will be applied in continuous mode, 3 MHz with the intensity of 1 W/m^2 in slow circular movements or in a longitudinal pattern will be performed three times a week, every other day, for a total of 12 sessions over four weeks. Following which, the treatment area will be exposed and ice pack fomentation will be applied for 10 to 20 mins. Stretching exercises will be given (30 seconds, 10 stretches every session, once per day), isometric for wrist flexion, wrist extension, wrist radial deviation, wrist ulnar deviation (3 to 5 second hold and 10 repetition/ session once daily), and praying position stretches for 10 to 30 seconds hold and 10 repetition/session once daily.⁸^,⁹

Active Release Technique

Patient position

The patient will sit with the forearm in mid-prone, elbow extends, wrist in neutral position and resting on the treatment table. Then the therapist will apply pressure to the muscles and the patient will extend the elbow, pronate the forearm, and flex the wrist from a shortened to a lengthened position as the therapist holds the muscles. Following which, the therapist will adjust the pressure proximally in an effort to break up adhesions within and between muscle planes.

Dosage

A total of 12 sessions of 10 minutes each will be performed, three times a week, over four weeks.¹⁰

Cyriax technique

Patient position

The patient will sit on a chair while holding a pillow.

Deep transverse friction (DTF)

DTF and manipulation, which will be done right after DTF, are both parts of the Cyriax physiotherapy regimen. DTF will be performed by pressing on the teno-osseous junction with the tip of the thumb’s side facing backward. This pressure will be maintained while the therapist applies DTF in the direction of their fingers, which will be placed on the opposite side of the elbow to apply counter pressure. After obtaining the numbing effect, the tendon will be prepared for Mill’s manipulation.⁷

Mill’s manipulation

The subjects arm will be held under the elbow’s crook while the shoulder joint will be medially rotated and pronated at the forearm. The hand that holds the elbow in the crook will transfer to the back of the elbow joint, and the patient’s elbow will be stretched until all the slack in the tendon had been picked up while preserving full wrist flexion and pronation. Then, while side-flexing away from the arm, the therapist will deliver a small-amplitude, high-velocity thrust while neatly pushing downward with the hand over the patient’s elbow.

Dosage

A total of 12 sessions will be performed, three times a week, for four weeks.⁹^,¹¹

Criteria for discontinuing allocated interventions for a given trial participant

If any patients in any of the allocated groups develop complications (i.e., worsening of disease or rupture of tendon), their participation in the study will be discontinued. The patients will then receive appropriate care and offered outpatient rehabilitation as needed. Study participants will be retained in the trial (unless they withdraw their consent) to enable follow-up data collection and to prevent missing data.

Adherence and concomitant care

For the purpose of ensuring adherence to the study, the patients will be informed and reminded of the sessions in advance through messages sent to their mobile phones. Additionally, if a patient misses a session for any reason, the standby days from the week will be used so that the patient still receives 12 sessions of intervention throughout the course of the four-week period.

All enrolled patients will be encouraged to contact the principal investigator directly if experiencing problems related to their allocated group intervention. The principal investigator will then fill out a standardized form at these calls. To avoid study-contamination, patients will be asked to adhere to the allocated rehabilitation intervention and not to seek alternative health-care services during the course of the study. Patients will be advised to contact their general practitioner or the principal investigator as needed.

Outcome measures

Time frame: At baseline and 4 weeks later.

Primary outcome

Change in visual analogue scale (VAS)

First employed by Hayes and Patterson in 1921, the VAS is a scale for assessing the intensity of pain¹^–¹⁰ on a subjective basis. The two ratings are based on self-reported indicators of symptoms that are recorded with a single handwritten mark placed at one point along a 10-cm line that represents a continuum between the scale’s two ends—“no pain” on the scale’s left end (0 cm) and “worst pain” on the right end (10 cm)—to determine the scores. The distance in centimetres between the scale’s starting point (left end) and the patient marks how much pain they are experiencing. Additionally, VAS scores exhibit ratio-level scoring characteristics and are correlated with pain behaviours. The information can be used to track an individual’s discomfort rise or to compare patients with similar illnesses’ pain levels.¹²

Secondary outcome

Change in hand grip strength dynamometer

The maximal force or tension produced by one’s forearm muscles is measured as grip strength, which is a component of muscular strength. It is an evaluation tool for determining upper limb strength and overall strength. The patient is positioned in a seated position with the shoulder abducted, elbow extended to 90 degrees, forearm neutral, and wrist neutral. The therapist places the dynamometer in the patient’s hand, holding the dynamometer’s base gently while giving the client instructions to squeeze as tightly as they can. Smooth application of grip force is preferred than a quick jerking motion. During the grip, allow the wrist to expand. As we become older, our grip strength weakens, which eventually begins to affect our day-to-day.

Change in Patient-rated tennis elbow evaluation (PRTEE)

The patient’s pain and function will be estimated by the PRTEE over the previous week. The questionnaire has 15 questions, the first five of which are about pain in the elbow and the following 10 of which are about how the elbow or elbows function. The discomfort and functioning scales include 11 degrees, with 0 denoting no pain or difficulty accomplishing a task and 10 denoting the worst pain possible or complete inability to perform a task. The cumulative score for every question, including the pain and function questions, is the final score. It consists of 15 questions, 10 of which are about functional limitations in everyday life, at work, and in sports, and five of them are about pain. The overall score goes from 0 (no pain or disability) to 100 (worst possible pain and impairment), and both subscales equally contribute to it. Before these cutoffs were validated, scores greater than 54 were considered to indicate serious discomfort and impairment, while values lower than 33 were considered to indicate mild pain and disability.¹³

Sample size calculation

Using a power analysis with 80% power and 5% Type 1 error for the primary variables, we calculated the sample size. The VAS score contrasts with the traditional group’s mean score variance between baseline and end visits. We used the previously calculated effect size difference in percentage from the RCT for the study.⁷ Formula using mean difference:

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

Primary Variable (VAS)

Mean ± SD. (Pre) result on VAS for conventional lateral epicondylitis (Control group) = 8.60 ± 0.50.

Mean ± SD. (Post) result on VAS for conventional lateral epicondylitis (Control group) = 4.40 ± 0.50.

Difference = 4.2 ± 0.50. (As per the reference article⁷)

Clinically relevant superiority = 10 % = (4.2*10)/100 = 0.42.

As the reference article.⁷

N1 = 2^{*} [{(1.96 + 1.28)}^{2} {(0.42)}^{2}] / {(0.50)}^{2} = 30

Total samples required = 30 per group.

Total sample size required = 60

Notations:

Z_{α} = 1.96 at 5 % l . o . s .

α = Type I error at 5%

Z_{β} = 1.28 (1 - β) = Power at 90 %

σ = std . dev = 0.5 pooled std . dev

Data collection, management and analysis

Data collection methods

The participants will be evaluated in accordance with the inclusion and exclusion criteria prior to group assignment. The indicated outcome measures’ baseline evaluation will come next. All participants will be randomly assigned to either Group A or Group B after the randomization process. For four weeks, the intervention will be given three days a week for 30 minutes each. After the final day of the intervention session, the post intervention data for the outcomes will be recorded. The information will be gathered and examined in order to study the outcomes. Throughout the course of the study, the guide will supervise the principle investigator as they administer the study interventions. The data collection staff will monitor every recording of the participants during the trial, which will last four weeks. Based on sections and variables, all entries will be saved in a database. This will assure data quality and confidentiality. For the thorough analysis of the dataset, all entities for values will be completely checked that there is no missing data.

Data management

The evaluation data will be gathered from a pre-set spreadsheet with varied baseline characteristics. The research data will be stored in a safe database. Hard copies of evaluation forms, signed informed consent forms, and other non-electronic documents will be safely preserved in the study setting. Every month until the trial is over, a complete backup of the data entries will be performed. The accuracy of the research papers must be properly reviewed. At the end of the study, a Microsoft Excel spreadsheet will be published and delivered to the statistician for the necessary analysis. Checklists can be used to prevent data loss caused by ineffective staff practices. Due to the thorough follow-up assessment of this trial, participant retention and completion of follow-up assessments are anticipated to be quite high. Patients included in this trial are invited to follow-up assessments at four weeks.

Statistical analysis

The overall result will be calculated using R studio software 4.3. Descriptive statistics will be calculated on the quantitative assessment for the variable like age with the parameters mean standard deviation maximum, minimum, median. For the qualitative assessment frequency and percentage will be calculated for the variables (hand dominance and occupation, gender). All the results for the inferential statistic will be tabulated and tested for the significance at 5% level of significance P=>0.05. The outcome variables (primary, VAS for the measurement of pain; secondary, hand grip strength dynamometer for the measurement of grip strength and patient- rated tennis elbow evaluation for the measurement of functional performance) will be evaluated for testing the pre post result using paired t-test. Kolmogorov-Smirnov will be used to check the outcome measure’s normalcy at first. If the data cannot be transformed into a normal distribution, the mathematical algorithm for the log, inverse function, exponential, or boxcox transformation will be used. Alternative non-parametric tests will be employed to validate the results of the parametric test if the data’s non-normal distribution continues. Wilcoxon sign test is an alternative for the paired t-test. Unpaired t-test will be used to find the significant difference over the mean of both primary and secondary variables between ART and Cyriax technique. Alternate non parametric Mann Whitney test will be used for the unpaired t-test. Association analysis for finding significance of cofounding parameters will be evaluated by using Chi-squared test or Fisher’s exact test or by using multi-variant analysis.

Monitoring

Data monitoring

We will have a data monitoring committee for maintaining and integrating the data.

Harms

The whole procedure will be carried out under the direction of a departmental committee and clinical staff. Any injuries or adverse events will be immediately reported to the committee during the trail. The completed dataset will be uploaded on the institutional repository website and made available to the appropriate authorities.

Ethics and Dissemination

Ethical consideration

Datta Meghe Institute of Higher Education and Research, Sawangi Wardha granted ethical approval (date, 21/03/2023; reference number, DMIHER (DU)/IEC/2023/802). This protocol has been registered on Clinical Trials Registry – India (CTRI; trial registration number, CTRI/2023/06/053660; registered on 08/06/2023).

Protocol amendments

The study received approval from the Scrutiny Committee at the college level on 01/03/2023 and the IEC at the university level on 21/03/2023. CTRI registration has also been completed since these approvals. The study has already been modified and authorized based on the suggestions made through these committees. So further changes cannot be carried out.

Consent

Members of the trial committee will provide the consent form to the participants in the trial and will inform and explain all the potential benefits and risks to the participants.

Confidentiality

The participant and a member of their family will be given a detailed explanation of the study plan, and the primary investigator will collect personal data as part of the protocol. The confidentiality statement and the lead investigator, the patient, and two witnesses will all sign the consent form. Every time information for the study needs to be disclosed, the patients consent will be acquired with full assurance of confidentiality.

Ancillary and post-trial care

The whole procedure is going to held under the supervision of clinicians and the departmental committee i.e., Guide, Head of department, Principal and member of Research Guidance Cell. After the trial session, the participations are going to be under supervision for about four weeks so that if there will be any harm, the Principal Investigator will take care of the participants.

Access to data

The final trail datasheet will be accessible to the principal investigator who will be conducting the study.

Dissemination policy

Preparing to present the work in International Conference Proceedings and publish in an indexed journal.

Study status

The study is yet to be started.

Discussion

Tennis elbow is one of the most common lesions of the arm. Pain in the lateral epicondyle gets worse when the extensor carpi radialis brevis muscle contracts against resistance.¹⁴ The extensor muscles that arise from the lateral epicondylar portion of the humerus are affected by this overuse injury, with the extensor carpi radialis brevis musculotendinous junction seeing the highest incidence.¹⁵ People who work in occupations that frequently require forearm rotation, such as tennis players and carpenters, frequently experience it. It is typically brought on by grasping the wrist and faster, more frequent, cyclic eccentric contractions.¹⁶ The incidence of 1-3% in the general population indicates that the dominant arm is the one that is most commonly affected. Tennis elbow occurs 4–7 times per 1,000 patients per year in general practice, peaking in individuals between the ages of 35 and 54 years. Equally affected are both men and women.¹⁴

The main focus of conventional tennis elbow treatment has been pain management with anti-inflammatory drugs, ultrasound, phonophoresis, or iontophoresis. P. Michael Leahy created ART, a deep tissue treatment for removing adhesions and scar tissue and regaining flexibility and function. Deep digital tension is applied over discomfort during ART, and in order to break any formed adhesions, an individual is actively asked to move the tissue from a shortened to a lengthened posture.¹⁷ The specific soft tissue massage technique known as “deep friction massage” or “cross friction massage” was created by Cyriax. Deep Friction Massage (DFM) keeps the soft tissue structures of ligaments, tendons, and muscles mobile while preventing the development of adhesion-prone scar tissue.¹⁸ Increased friction can also help to break down previously formed adhesions.⁹

The present research objective is to evaluate the impact of ART and the Cyriax technique on participants with subacute lateral epicondylitis in terms of pain, strength, and function. In one study conducted by Ramteke and Samal,¹⁹ they studied the effect of rotator cuff exercises on tennis elbow. In total, 30 patients were randomly selected and split into two equal groups: Group 1 (the control group) and Group 2 (the interventional group). Group A (15 patients) underwent traditional treatment, good scapular control, and rotator cuff strengthening. Group B (15 patients) received traditional care, mostly using electrotherapeutic modalities and taping for elbow exercises. Before taking part in the study, the players were informed of the specific treatments they would be subjected to over the course of six weeks and need to sign a consent form. Six days a week, the regimen was followed for 10 sittings. The outcome measures were assessed pre and post with the help of patient rated tennis elbow evaluation scale and VAS. After that, both the study group and the experimental group received a home workout regimen. As a result, there was no apparent age difference between the two groups. The mean pain score on the VAS was 4.66 1.77 for group A and 7.13 1.30 for group B. The conclusion of this study infers that a rotator cuff strengthening program is significantly effective in reducing pain and enhancing functional activity.¹⁹ In a randomised controlled study conducted by Uttamchandani and Phansopkar,²⁰ the individuals (n=50) with lateral epicondylitis were separated into either an intervention group or a control group, with 25 subjects in each group. Group A used the “PowerBall device” for a strength training programme that was conducted across five sessions per week for three weeks, lasting anywhere between 20 and 64 minutes per session. Depending on the subject’s capacity, the “PowerBall device” frequency was then be determined by the total rounds fired each minute, which ranged from 2,000 to 10,000. Patients with lateral epicondylitis in group B underwent Mulligan Mobilisation with Movement (MMWM). The therapist used the approach 30 times in one session. There was a one-minute break after 10 repetitions. Each session lasted 30 to 60 minutes. Three sets of movement mobilisations were performed during each session, with five sessions scheduled each week over the following three weeks. The patient-rated tennis elbow evaluation scale, Hand Dynamometer, VAS, and range of motion were utilised to measure the outcomes both before and after treatment. The conclusion of this study was that Mulligan Mobilisation was widely regarded as having the biggest impact on pain in patients with lateral epicondylitis, which makes sense given all the factors involved and the treatment’s successful outcomes.²⁰ The ART and the Cyriax technique will be evaluated for their effects on participants with subacute lateral epicondylitis in terms of pain, strength, and function using the primary (i.e., VAS) and secondary (i.e., hand dynamometer and patient-rated tennis elbow evaluation scale) outcome measures. The advantages of the survey allow for a personalised approach to the rehabilitation protocol and the flexibility to adjust to the patients’ increasing abilities throughout the course of therapy. The study’s findings will help future lateral epicondylitis patients by presenting a more effective and advanced rehabilitation strategy.

Data availability

Underlying data

No data are associated with this article.

Extended data

Zenodo: Aditi- Extended data Sheet-.docx. https://doi.org/10.5281/zenodo.8299769.²¹

This project contains the following extended data:

- Data collection form
- Model consent form
- Flowchart of procedure
- Schedule of enrolment, interventions and assessments

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol’. https://doi.org/10.5281/zenodo.8013637.²²

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

Acknowledgements

I would like to express my gratitude to Mr. Lakshmikant Umate for data analysis planning and sample size.

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16. Flanders M: The clinical effectiveness of therapeutic exercises alone and in combination with orthotic bracing in the treatment of lateral epicondylalgia.
17. Kim JH, Lee HS, Park SW: Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J. Phys. Ther. Sci. 2015 Aug; 27(8): 2461–2464. PubMed Abstract | Publisher Full Text | Free Full Text
18. Chaves P, Simões D, Paço M, et al.: Cyriax’s deep friction massage application parameters: Evidence from a cross-sectional study with physiotherapists. Musculoskelet. Sci. Pract. 2017 Sep 1; 32: 92–97. PubMed Abstract | Publisher Full Text
19. Ramteke S, Samal S: To Study the Effect of Rotator Cuff Exercises on Tennis Elbow. Indian J. Public Health Res. Dev. 2020; 11(3): 610–614.
20. Uttamchandani S, Phansopkar P: A Research Protocol to Evaluate the Efficacy of Powerball versus Mulligan Mobilization with Movement on Pain and Function in Patients with Lateral Epicondylitis. J. Pharm. Res. Int. 2021 Oct 9; 33(45B): 491–500. Publisher Full Text
21. Nagore AN: Aditi. Extended data Sheet-.docx. [Dataset]. Zenodo. 2023 Aug 30 [cited 2023 Aug 30]. Reference Source
22. Nagore A: SPIRIT_checklist - Aditi.docx. [Dataset]. Zenodo. 2023 Jun 7 [cited 2023 Aug 30]. Reference Source

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¹ Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442004, India

Aditi N. Nagore
Roles: Conceptualization, Writing – Original Draft Preparation

Subrat Samal
Roles: Supervision, Validation

Competing interests

No competing interests were disclosed.

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The author(s) declared that no grants were involved in supporting this work.

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Published: 20 Sep 2023, 12:1175

https://doi.org/10.12688/f1000research.138130.1

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Nagore AN and Samal S. Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1175 (https://doi.org/10.12688/f1000research.138130.1)

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Reviewer Report 14 May 2024

Neha Shukla, PHYSIOTHERAPY, CSJM University, Kanpur, UP, India

Dr Adarsh Kumar Srivastav, PHYSIOTHERAPY, CSJMUniversity, KANPUR, UP, India

Approved

https://doi.org/10.5256/f1000research.151307.r247984

Overall, the protocol exhibits a robust framework for conducting a randomized clinical trial to investigate the effectiveness of the Active Release Technique (ART) and the Cyriax technique in treating lateral epicondylitis. The inclusion of power analysis for sample size determination ... Continue reading

Overall, the protocol exhibits a robust framework for conducting a randomized clinical trial to investigate the effectiveness of the Active Release Technique (ART) and the Cyriax technique in treating lateral epicondylitis. The inclusion of power analysis for sample size determination ensures adequate statistical power, while the clear data collection, management, and analysis plan enhance the study's internal validity and reliability. However, I have further suggestions to improve the quality of the manuscript.
1. While the introduction provides a comprehensive overview of lateral epicondylitis and the interventions under investigation, it could benefit from a more integrated discussion of current evidence supporting the efficacy of ART and the Cyriax technique.
2. The protocol mentions the use of the Visual Analogue Scale (VAS), hand grip strength dynamometer, and PRTEE scale as outcome measures, the authors could provide more information on the reliability, validity, and interpretation of these measures.
3. The decision not to implement blinding is noted in the protocol, but a rationale for this choice is not provided. Lack of blinding can introduce bias, particularly in subjective outcome measures like pain assessment.
4. In eligibility criteria, some exclusion criteria, such as "recent history of steroidal infusion," could benefit from further clarification. Defining what constitutes a "recent" history (e.g., within the past six months) would provide clearer guidance for identifying eligible participants.
5. While the inclusion criterion specifies patients diagnosed with lateral epicondylitis, the protocol does not outline how the diagnosis will be validated. Details on the diagnostic criteria or methods used to confirm the diagnosis could be added.
6. Statistical analysis, the plan does not explicitly address how missing data will be handled in the analysis. Including strategies for handling missing data, such as imputation methods or sensitivity analyses, would ensure robustness in the statistical analysis.

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: Orthopaedic-related topics, Physiotherapy and rehabilitation.

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Neha Shukla, CSJM University, Kanpur, India

Dr Adarsh Kumar Srivastav, CSJMUniversity, KANPUR, India

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14 May 2024 | for Version 1

Neha Shukla, PHYSIOTHERAPY, CSJM University, Kanpur, UP, India

Dr Adarsh Kumar Srivastav, PHYSIOTHERAPY, CSJMUniversity, KANPUR, UP, India

3 Views Cite this report Responses(0)

Approved

Overall, the protocol exhibits a robust framework for conducting a randomized clinical trial to investigate the effectiveness of the Active Release Technique (ART) and the Cyriax technique in treating lateral epicondylitis. The inclusion of power analysis for sample size determination ensures adequate statistical power, while the clear data collection, management, and analysis plan enhance the study's internal validity and reliability. However, I have further suggestions to improve the quality of the manuscript.
1. While the introduction provides a comprehensive overview of lateral epicondylitis and the interventions under investigation, it could benefit from a more integrated discussion of current evidence supporting the efficacy of ART and the Cyriax technique.
2. The protocol mentions the use of the Visual Analogue Scale (VAS), hand grip strength dynamometer, and PRTEE scale as outcome measures, the authors could provide more information on the reliability, validity, and interpretation of these measures.
3. The decision not to implement blinding is noted in the protocol, but a rationale for this choice is not provided. Lack of blinding can introduce bias, particularly in subjective outcome measures like pain assessment.
4. In eligibility criteria, some exclusion criteria, such as "recent history of steroidal infusion," could benefit from further clarification. Defining what constitutes a "recent" history (e.g., within the past six months) would provide clearer guidance for identifying eligible participants.
5. While the inclusion criterion specifies patients diagnosed with lateral epicondylitis, the protocol does not outline how the diagnosis will be validated. Details on the diagnostic criteria or methods used to confirm the diagnosis could be added.
6. Statistical analysis, the plan does not explicitly address how missing data will be handled in the analysis. Including strategies for handling missing data, such as imputation methods or sensitivity analyses, would ensure robustness in the statistical analysis.

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

Orthopaedic-related topics, Physiotherapy and rehabilitation.

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

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[1] 1. Tarpada SP, Morris MT, Lian J, et al.: Current advances in the treatment of medial and lateral epicondylitis. J. Orthop. 2018 Mar 1; 15(1): 107–110. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Fernández-Carnero J, Fernández-de-las-Peñas C, de la Llave-Rincón AI , et al.: Prevalence of and Referred Pain From Myofascial Trigger Points in the Forearm Muscles in Patients With Lateral Epicondylalgia. Clin. J. Pain. 2007 May; 23(4): 353–360. PubMed Abstract | Publisher Full Text

[3] 3. Landesa-Piñeiro L, Leirós-Rodríguez R: Physiotherapy treatment of lateral epicondylitis: A systematic review. J. Back Musculoskelet. Rehabil. 2022 Jan 1; 35(3): 463–477. PubMed Abstract | Publisher Full Text

[4] 4. The Role of Active Release Manual Therapy for Upper Extremity Overuse Syndromes—A Preliminary Report|SpringerLink: [cited 2023 Jan 25]. Publisher Full Text

[5] 5. Kalaskar G, Gurjalwar I, Phansopkar P, et al.: Effect of Cyriax physiotherapy and conventional ultrasound on lateral epicondylitis.11(2320). Publisher Full Text

[6] 6. Balasuburamaniam A, Kandaswamy M: Effect of Myofascial Release Therapy and Active Stretching on Pain and Grip Strength in Lateral Epicondylitis. J. Riphah. Coll. Rehabil. Sci. 2016 Sep 8; 4: 3–6.

[7] 7. Kalaskar G, Phansopkar P: A Comparative Study to Evaluate the Efficacy of Supervised Exercise Program and Cyriax Physiotherapy on Pain and Function in Lateral Epicondylitis.2021 Nov 18 [cited 2023 Feb 21]; 87–97. Publisher Full Text

[8] 8. Zaghloul HMS, Ali HA, Ghally SAO, et al.: Comparison of The Effectiveness of Instrument-Assisted Soft Tissue Mobilization Technique, Ultrasound therapy, or Deep Friction Massage on Fast Recovery and Accelerating Tissue Healing in Groin Strain.2020.

[9] 9. Dabkara P, Daniel J, Sharma M, et al.: A Study to Compare the Effectiveness of Active Release Technique Versus Deep Friction Massage on Pain, Grip Strength and Functional Performance in Patients with Chronic Lateral Epicondylitis. Indian J. Public Health Res. Dev. 2022 Jun 24; 13(3): 222–227. Publisher Full Text

[10] 10. Basu DS, Bhatia DD, Palekar T, et al.: EFFECTIVENESS OF ACTIVE RELEASE TECHNIQUE IN THE TREATMENT OF CHRONIC LATERAL ELBOW PAIN.

[11] 11. Ashfaquzzaman M: Effectiveness of a mill’s manipulation for tennis elbow patient [Thesis]. Bangladesh Health Professions Institute, Faculty of Medicine, the University of Dhaka, Bangladesh.2020 [cited 2023 Feb 22]. Reference Source

[12] 12. Delgado DA, Lambert BS, Boutris N, et al.: Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J. Am. Acad. Orthop. Surg. Glob. Res. Rev. 2018 Mar 23; 2(3): e088. PubMed Abstract | Publisher Full Text | Free Full Text

[13] 13. Rompe JD, Overend TJ, MacDermid JC: Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J. Hand Ther. 2007 Jan 1; 20(1): 3–11. PubMed Abstract | Publisher Full Text

[14] 14. Cutts S, Gangoo S, Modi N, et al.: Tennis elbow: A clinical review article. J. Orthop. 2019 Aug 10; 17: 203–207. PubMed Abstract | Publisher Full Text | Free Full Text

[15] 15. EVALUATION OF THE EFFECT OF MOBILIZATION WITH MOVEMENT ON PAIN, KINESIOPHOBIA AND ACTIVITIES OF DAILY LIVING IN LATERAL EPICONDYLITIS - AN EXPERIMENTAL STUDY - ProQuest.[cited 2023 Sep 4]. Publisher Full Text

[16] 16. Flanders M: The clinical effectiveness of therapeutic exercises alone and in combination with orthotic bracing in the treatment of lateral epicondylalgia.

[17] 17. Kim JH, Lee HS, Park SW: Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J. Phys. Ther. Sci. 2015 Aug; 27(8): 2461–2464. PubMed Abstract | Publisher Full Text | Free Full Text

[18] 18. Chaves P, Simões D, Paço M, et al.: Cyriax’s deep friction massage application parameters: Evidence from a cross-sectional study with physiotherapists. Musculoskelet. Sci. Pract. 2017 Sep 1; 32: 92–97. PubMed Abstract | Publisher Full Text

[19] 19. Ramteke S, Samal S: To Study the Effect of Rotator Cuff Exercises on Tennis Elbow. Indian J. Public Health Res. Dev. 2020; 11(3): 610–614.

[20] 20. Uttamchandani S, Phansopkar P: A Research Protocol to Evaluate the Efficacy of Powerball versus Mulligan Mobilization with Movement on Pain and Function in Patients with Lateral Epicondylitis. J. Pharm. Res. Int. 2021 Oct 9; 33(45B): 491–500. Publisher Full Text

[21] 21. Nagore AN: Aditi. Extended data Sheet-.docx. [Dataset]. Zenodo. 2023 Aug 30 [cited 2023 Aug 30]. Reference Source

[22] 22. Nagore A: SPIRIT_checklist - Aditi.docx. [Dataset]. Zenodo. 2023 Jun 7 [cited 2023 Aug 30]. Reference Source

Effect of Active Release Technique and Cyriax approach on pain, grip strength and functional performance in individuals with lateral epicondylitis: a randomized clinical trial protocol

Abstract

Keywords

Introduction

Aim and objectives

Trial design

Protocol

Figure 1. Flowchart of procedure.

Eligibility criteria

Interventions

Outcome measures

Sample size calculation

Data collection, management and analysis

Statistical analysis

Monitoring

Ethics and Dissemination

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

Acknowledgements

References

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