Keywords
Blood Flow Restriction Training, Persistent Neck Pain, Pressure Pain threshold, Hand grip strength, hand function
Blood Flow Restriction Training, Persistent Neck Pain, Pressure Pain threshold, Hand grip strength, hand function
Persistent neck pain is a prevalent and debilitating condition that affects a significant number of adults worldwide.1 The burden of this condition on individuals’ quality of life and productivity underscores the need for effective and innovative interventions to alleviate pain and improve functional outcomes.2 Blood flow restriction (BFR) training has emerged as a promising technique that has shown potential benefits in enhancing muscular strength and promoting tissue adaptation without subjecting the body to high-intensity exercises.3 Despite its applications in various musculoskeletal conditions, the potential efficacy of BFR training in managing persistent neck pain remains relatively unexplored. This study protocol aims to investigate the effect of blood flow restriction training on pressure pain threshold and hand function among adults suffering from persistent neck pain. Utilizing a randomized controlled trial design, this research seeks to provide valuable insights into the role of BFR training as a potential therapeutic option for this challenging and often refractory condition. The rationale for examining pressure pain threshold lies in its significance as a common clinical measure for assessing pain sensitivity and tolerance, particularly in musculoskeletal pain conditions.4 Understanding the impact of BFR training on pressure pain threshold will offer valuable information on the technique’s ability to modulate pain perception in individuals with persistent neck pain. Additionally, assessing hand function is of paramount importance, as neck pain can often result in functional limitations that affect daily activities and work performance.5 Investigating the effects of BFR training on hand function will shed light on whether this intervention can lead to functional improvements and enhance the overall well-being of individuals experiencing neck pain. The results obtained from this research hold the potential to inform healthcare practitioners, physiotherapists, and other relevant professionals about the feasibility and effectiveness of incorporating BFR training into the management strategies for individuals with persistent neck pain. By addressing the current research gap and exploring the impact of BFR training on pressure pain threshold and hand function, this study protocol aspires to contribute to evidence-based practices in pain management and rehabilitation, ultimately enhancing the quality of life for those affected by persistent neck pain.
I. To evaluate the effect of BFRT in alleviating neck pain and improving the hand function among adults with persistent neck pain.
II. To study the impact of BFRT on disability and quality of life among patients with persistent neck pain.
III. To study the long term effect of BFRT on Precision and Power grip among adults with Persistent neck pain.
This study will be a prospective randomized active controlled trail to be done at Physiotherapy Department, Galgotias University.
There is no difference between the BFRT and conventional physiotherapy group in alleviation of pain, and hand function among adults with neck pain.
BFRT will have a significant impact in reducing pressure pain threshold and improving hand function in patients with persistent neck pain among adults.
Subjects
One hundred and ten self-reporting persistent neck pain for more than three months duration will be screened for eligibility and recruited in the study. After obtaining informed consent, the participants will be randomly allocated in 1:1 ratio to the BFR training group and the control group using a computer-generated randomization sequence. Allocation concealment will be ensured to maintain blinding and reduce potential bias. Sample size was calculated using Gpower version 3.1.9.4 for Windows by assuming effect size of 0.5(Cohen’s D medium size effect was assumed) with the margin of error (α) to test the level of significance was set at 0.05 and (1-α) 80% βpower and confidence interval at 95%, the final derived sample with added 10% of contingency was n=1126 (Figure 1). See Figure 2 for central and non-central distributions.
Participants with self-reported persistent neck pain for than 3 months, aged 18 and above, both males and females, patients with weak power grip, impaired hand precision function and willing to prospectively attend the interventions will be included in the study.
The exclusion criteria will be patients those who have history of receiving BFRT, deformity of upper extremity, spinal deformity, unhealed injuries in spine and upper extremity, uncontrolled hypertension, history of deep vein thrombosis and medically diagnosed neurological conditions that interfere with hand function or causes pain.
Written informed consent will be obtained from all the participants who are eligible to be included in the study. The diagnosis of persistent neck pain will be made based on previous history and duration. Patients with radiating pain to shoulders or hands will be excluded. Enrolment, intervention, and assessment will be done as per the SPIRIT guideline (Table 1). Participants will be obtained from the OPD of Physiotherapy Department and from all over the university including the teaching, non-teaching staff, from camps nearby and students. Ethical clearance has been obtained from Departmental Ethics Committee on 19/05/2023 with reference number DEC/PT/GU/2023 and the Trial has been registered with Clinical Trial Registry India CTRI/2023/06/053439. All patients diagnosed with chronic neck pain and weak hand function will sign the informed consent. Demographic data, history and other data will be obtained at the baseline. The study will be done in accordance to the declaration of Helsinki.7
All patients will receive standard physiotherapy care. It will include thermo therapy, neck isotonic exercises. The Experimental group will also receive BFR with single session with 75 vol LOP 40 to 50 % for upper grip ball exercise (Light resistance) wrist curls and wrist extension using long leavers Flexibar radial and ulnar deviation. Follow up will be done for the patients on second visit after 8 weeks and long-term follow up after 6 months for others on phones who fail to come for follow up. All the patients will be explained about the possible benefits and complete procedure of the study and consent will be signed by each patient who is willing to participate in the study. They will be told its voluntary and they can withdraw anytime from the study and it won’t affect their treatment if they refuse to be part of the study. Patient information will be kept confidential. Each individual will serve as self-control to report about the possible benefit in pain score after receiving BFRT and after follow up. See Table 2 for the full BFRT protocol.8
Pressure pain threshold using Algometer
Using an algometer, a portable instrument that measures pressure sensitivity at particular anatomical locations in the neck region, the pressure pain threshold (PPT) will be determined. The algometer consists of a gauge with a pressure-sensing tip attached that measures applied pressure in kilopascals (kPa). Before the assessments begins, the algometer will be calibrated to ensure accuracy and consistency of measurements. Participants will be comfortably seated in an upright position with their neck muscles relaxed. It is essential to explain the procedure to the participant, ensuring they understand the assessment and can provide feedback on their pain perception. Specific anatomical points in the neck region will be chosen for the assessment. Commonly, these points include the trapezius, levator scapulae, and sternocleidomastoid muscles. The researcher will progressively apply pressure to the selected spots using the algometer. A button must be pressed to cease the pressure application or the participant must verbally report feeling pain for the pressure to increase at a constant rate (for example, 1 kPa/s).
Neck Outcome Score
The Neck Outcome Score (NOS) is a self-reported questionnaire that assesses various aspects of neck pain and its impact on daily activities and quality of life. Participants will be provided with the NOS questionnaire, and the research team will explain its purpose and how to complete it. It’s important to ensure that participants understand the questions and how to score their responses accurately. The NOS typically includes questions related to pain intensity, pain-related disability, functional limitations, and the impact of neck pain on quality of life.
Grip strength using hand help dynamometer
Grip strength will be measured using a handheld dynamometer. We will ensure that the participant is well-rested and not fatigued before the measurement. We will also inform the participant about the purpose of the grip strength measurement and the procedure involved. The dynamometer will be adjusted to fit the participant’s hand size. The participant will be seated on a chair without armrests, ensuring proper posture with their back straight, feet flat on the ground, and forearm resting on a flat surface. We will instruct the participant to hold the dynamometer in their dominant hand. When the participant is ready, they should be instructed to squeeze the dynamometer handle with maximum effort for about 3 to 5 seconds. The researcher can provide encouragement to the participant during the measurement to ensure they exert their maximum effort. The highest grip strength measurement achieved during the trial will be recorded.
WHO-5 quality of life index questionnaire
The WHO-5 quality of life index questionnaire is used to assess an individual’s subjective well-being and quality of life. We will briefly explain the purpose of the WHO-5 questionnaire to the participant and let them know that it’s designed to assess their emotional well-being and quality of life. Participants will rate their agreement with each statement on a scale from 0 to 5, where 0 indicates “at no time” and 5 indicates “all of the time”. After participants have provided their responses, we can assist them in calculating their total score. A higher score on the WHO-5 indicates better emotional well-being and quality of life.
Data will be analysed using IBM Statistical Package for Social Sciences version 21 for Windows. The patient characteristics at the baseline will be presented as mean, standard deviation and proportion with 95% confidence interval. The kolmogorov-smirnov and Shapiro Wilk test will be performed to assess the normality distribution of all the outcome scores. The student’s t- test and paired t-test will be used to compare between the groups and intra group and multiple regression analysis will be done to check for any correlation or any factor influencing the outcomes of the study.
The present study protocol presents a RCT testing the effectiveness of BFRT on pressure pain threshold and hand function among adults with persistent neck pain. The intervention aims to reduce pain and hand function by the proposed mechanism. The study intends to employ a randomized controlled trial design, ensuring scientific rigor and minimizing bias. By comparing the BFR training intervention group with a control group, researchers seek to assess the impact of this innovative technique on two primary outcomes: pressure pain threshold and hand function. Therefore, we expect that the adults with neck pain and compromised hand function in the BFRT group will exhibit improvement in terms of pain and hand function in comparison to the neck pain patients in the conventional group. The significance of this research lies in its potential to contribute valuable insights into managing neck pain and improving hand function using a novel approach like BFR training. If the results show positive effects, it could pave the way for a non-invasive, safe, and cost-effective intervention for individuals dealing with persistent neck pain. Ultimately, this study may have a meaningful impact on the quality of life for those suffering from this prevalent issue, offering hope for improved pain management and functional recovery.
Study Status: At the moment the authors are involved in training the assessors and physiotherapists those who will be involved in interventions and we are planning to start screening after one month.
The chronic neck pain may progress to cause disability and diminished quality of life. A non-invasive timely intervention may cause halting adverse effects of central sensitization in patients suffering chronic neck pain. A simple and novel intervention may be incorporated.
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Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Partly
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
References
1. Steele J: Intensity; in-ten-si-ty; noun. 1. Often used ambiguously within resistance training. 2. Is it time to drop the term altogether?. Br J Sports Med. 2014; 48 (22): 1586-8 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Blood flow restriction, resistance training, pressure pain threshold, blood pressure measurements, strength assessments, ultrasound muscle thickness assessment, and cognitive function assessment.
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?
Partly
Are the datasets clearly presented in a useable and accessible format?
Partly
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: wet cupping therapy, pain, stroke
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?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Musculoskeltal disorders, clinical epidemiology, cross-cultural research
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Version 1 31 Aug 23 |
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