Effects of Bilateral Asymmetrical Limbs Proprioceptive Neuromuscular Facilitation on Multifidus Muscle in CLBP.

Study Overview
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Brief Summary
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The low back pain is a leading cause to limit individual functional activities worldwide and 60%-80% of adults are probable to get low back pain at least once in life time. Whereas, the chronic low back pain prevalence is 10%.The current literature suggests that any exercise is beneficial for reducing chronic nonspecific low back pain. This limits evidence regarding superiority of specific exercise for low back pain treatment. Therefore, a randomized control trial will be conducted at department of physiotherapy to assess which treatment is more effective in chronic low back pain at department of physiotherapy, institute of physical medicine and rehabilitation, Dow University of Health Sciences after synopsis approval. Overall 150 participants with 18-40 years old having chronic low back pain will be eligible and they will be included through non-probability, purposive sampling technique. The written informed consent will be taken from all the participants. They will be divided through systematic random sampling method into two groups, 75 in each group. Group A (experimental group) will receive Bilateral, asymmetrical limbs PNF pattern exercises and group B (control group) will receive Swiss ball exercises. All participants will be assessed using assessment form. Pain and functional disability will be measured by subjective outcome tools, visual analogue scale with 0-10cm and Oswestry disability index , respectively. Range of movement of lumbar and multifidus muscle activity will be measured by objective outcome tool, modified-modified Schober's test and surface electromyography, respectively. The pre & post treatment outcomes will be collected and recorded. Treatment sessions will be given thrice a week for 5 weeks. A maximum drop-out rate of 20% is expected. The Mean ± SD will be calculated for quantitative variables and frequencies and percentages for qualitative variables. The recorded outcome variables before and after the five weeks of treatment will be compared and analysed. The p-value of 0.05 will be considered as level of significant.

Detailed Description
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Globally, Low back pain (LBP) is the commonest musculoskeletal pain, for which participants consult general practitioners. It is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal fold, with or without referred leg pain. The LBP with specific causes are rare (<15%). Whereas, majority (>80%) of LBP cases are non-specific LBP (NSLBP). The traditional temporal categorization comprises as acute LBP (<6 weeks), sub-acute LBP (≤12 weeks) or chronic LBP (>12 weeks). It is based on the duration of the current episode. The LBP is experienced in 60% to 80% of adults at some point in lifetime. There is 15% annual worldwide incidence rate of LBP and 30% point prevalence. LBP is one of the five leading causes of YLDS that contributes 57•6 million. The estimation suggests 5% to 10% of LBP cases will develop chronic. This chronicity is responsible for high treatment expenses, sick leave, and different sufferings. The evidence based guidelines for LBP diagnosis suggest to first rule out any underlying pathology (spinal infection, cancer and fracture of spine and cauda equina syndrome). The LBP without any specific pathology is labelled as NSLBP. The routine use of radiologic imaging is not warranted based on clinical guidelines until presence of specific pathology. The goal of LBP treatment includes pain relief, function improvement, reduced work leave of absence, and chronicity prevention. The analgesics (topic or oral), exercise, manual therapy, traction, transcutaneous electrical nerve stimulation (TENS), back supports, acupuncture, biofeedback, spinal injections, and lastly, surgery may include in treatment options.Among exercise interventions the proprioceptive neuromuscular facilitation (PNF) exercise approach is designed to stimulate proprioceptors in order to enhance neuromuscular mechanism responses. The extremity patterns of PNF have diagonal direction with combination of movements, and these patterns are performed in line with the topographic arrangement of the muscles being used. Therefore, these exercises are thought to be suitable for muscles training anatomical-plane or anatomical-direction training programs. Moreover, PNF often have been used to improve the range of movement (ROM) and endurance. Various techniques of PNF training are used like rhythmic initiation, rhythmic stabilization, reversal of agonists, and reversal of antagonists. In the existing literature there is little direction with mixed evidence to physiotherapists that what intervention is more beneficial to apply for CLPB. According to author's knowledge, the base to rely on PNF techniques needs evidence related to PNF patterns specification, that which lower limb PNF pattern is more effective. A randomized clinical trial will be conducted to explore the effects of bilateral, asymmetrical lower limb PNF patterns in flexion and in extension on multifidus in CLBP to evaluate and stabilize evidence based physical therapy practice in Pakistan. Objectives: To explore the effects of limbs PNF pattern exercises and Swiss ball exercises on multifidus motor activity, lumbar ROM, pain and functional disability in CLBP. To determine the frequencies and statistical association of age, gender, body mass index (BMI) and occupation among participants in CLBP. To determine the statistical association among multifidus motor activity, lumbar ROM, pain and functional disability of participants with CLBP before and after the exercise treatment. T determine the effects of bilateral, asymmetrical limbs PNF pattern exercises and Swiss ball exercises in participants with CLBP To compare the effects of bilateral, asymmetrical limbs PNF pattern exercises and Swiss ball exercises in participants with CLBP Hypothesis: Null hypothesis: There is no difference between effects of bilateral asymmetrical limbs proprioceptive neuromuscular facilitation and Swiss ball exercises on multifidus muscle in chronic low back pain. Alternate Hypothesis: The effects of bilateral asymmetrical limbs proprioceptive neuromuscular facilitations are more beneficial than Swiss ball exercises on multifidus muscle in chronic low back pain. Methodology: Research design: The research design will be randomize control trial (RCT), experimental study. Sampling technique: Non probability purposive sampling technique will be used. Sample size: Initially, a sample size of 54 human subjects was calculated through open epi software with 95% Confidence Interval and 80% power of test with post-test VAS mean (2.1) and standard deviation (0.85), in experimental group and post-test VAS mean (1.5) and standard deviation (0.69) in control group. Due to small sample size, it is increased to 150 with drop rate of 20%. The 75 participants per group will be considered. Place of the study: Physiotherapy department, Institute of physical medicine and rehabilitation (IPM&R), Dow University of Health Sciences (DUHS), Chand Bibi road, Karachi, Pakistan. Data collection procedure: After taking consent, the objectives of study will be told to all participants.The participants will be randomly allocated into two groups. All the participants will be assessed with outcome measures before after 5 weeks of intervention. Interventions protocol: (half hour session, thrice a week for 5 weeks). Group A (experimental group) will receive, PNF rhythmic initiation with bilateral asymmetrical upper and lower limb pattern, The participant in supine position (on the back) with left arm in extension-adduction-internal rotation with right hand gripping his left wrist with right arm in modified extension-abduction-internal rotation. Neck will be in flexion looking at left hand. Therapist distal hand (hand away from head of the participant) will grip wrist of participant's left hand and the proximal hand (hand near to head of the participant) will be on top of the participant's head with fingers pointing towards the left side of participant neck. Participant will be asked to lift left arms and push the head back through the pattern of flexion -abduction-external rotation and neck in extension to the left in opposition of therapist hand resistance. At the end range of motion extensor muscles of back will start to contract. Then, participant will be asked to reverse the movement pattern to extension-adduction-internal rotation and neck flexion to right against the therapist resisting hands. It will be repeated on other side of participant. Then for lower limbs, participant's left leg will be in extension-abduction-internal rotation and right leg in extension-adduction-external rotation. Therapist will grasp the lateral and dorsal surfaces of both feet with distal hand. Proximal arm will be placed underneath the participant's thighs to hold them together. Then participant will be asked to lift both feet up, bend legs up and away towards right shoulder against therapist resistance. The right leg will go into flexion-abduction-internal rotation, the left leg into flexion-adduction-external rotation. At the end of range, the motion continues as lower trunk flexion with rotation and side-bending to the right. After that, participant will asked to reverse the left leg into extension-abduction-internal rotation and right leg in extension-adduction-external rotation against resistance. At end of range, the motion will carry on as trunk extension and elongation to the left with left rotation and side trunk flexion. It will be repeated on other side of participant. 10 repetition and 3 sets for each side, 20 second rest between two sets. Group B (control group) will receive Swiss ball exercises : Supine position: A ball will be placed under participant neck, and will be asked to bend hip and knee up to 90°. 5 times, 10 seconds hold Supine position: With a ball below the pelvis, knees bent, the ball press will be done with pelvis. 5 times, for 10 seconds hold. Crawling position: With a ball below one knee while keeping toes away from contact with the floor, the participant will balance first to stabilize the posture and slowly raise the other lower limb. This exercise will be performed in turn for the two lower limbs 10 times, with 10 seconds hold. Prone position: Participant will place a ball in front of pelvis and will repeatedly raise and lowered the two lower limbs alternately. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set. Data analysis: The Statistical package for the social sciences 21 version will be used for data analyzing. The mean and standard deviation will be calculated for quantitative variables like age. The qualitative variables will be shown through calculated frequencies and percentages. The outcome results of the study (decrease pain intensity, improve functional disability, improve range of movement and improve multifidus activity) taken before and after the treatment will be compared and analysed. The p-value of 0.05 will be considered as level of significant.

Official Title
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Effects of Bilateral Asymmetrical Limbs Proprioceptive Neuromuscular Facilitation on Multifidus Muscle in Chronic Low Back Pain (CLBP)

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Group A (PNF rhythmic initiation group )
* Other: Group B (Swiss ball exercises)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Low back pain (pain for > 3 month) Exclusion Criteria: Any history related to spinal surgery Previous administration of epidural injections. Low Back Pain due to specific pathology, Neurological deficits (like stroke) Clinical disorder contraindicated to exercise.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (PNF rhythmic initiation group )<br>PNF rhythmic initiation with bilateral asymmetrical upper and lower limb pattern will administered on both sides, there will be 10 repetition and 3 sets for each side, 20 second rest between two sets. | Other: Group A (PNF rhythmic initiation group )<br>* Lifting of arms and push the head back through the pattern of flexion -abduction-external rotation and neck in extension to the left in opposition of therapist hand resistance will be asked to do. At the end range of motion extensor muscles of back will start to contract.Then, reversing of that movement pattern to extension-adduction-internal rotation and neck flexion to right against the therapist resisting hands will be asked. this will be repeated on both sides<br>|
| Active Comparator: Group B (Swiss ball exercise group)<br>Swiss ball exercises will be administered. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set. | Other: Group B (Swiss ball exercises)<br>* Supine position: A ball will be placed under patient neck, and will be asked to bend hip and knee up to 90°. 5 times, 10 seconds hold Supine position: With a ball below the pelvis, knees bent, the ball press will be done with pelvis. 5 times, for 10 seconds hold. Crawling position: With a ball below one knee while keeping toes away from contact with the floor, the patient will balance first to stabilize the posture and slowly raise the other lower limb. This exercise will be performed in turn for the two lower limbs 10 times, with 10 seconds hold. Prone position: the patient will place a ball in front of pelvis and will repeatedly raise and lowered the two lower limbs alternately. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line. The scale is most commonly referred by no pain with score of 0 and worst imaginable pain with score of 100 on the scale. The higher scores shows higher pain intensity and lower scores shows lower pain intensity. | Change from baseline pain intensity at 5 weeks. | 
| Modified Modified Schober's test. | It is used during physical examination to assess the lumbar range of movement. It is highly co-related with lumbar range of movement measured through radiograph. | Change from baseline lumbar range of movement at 5 weeks. | 
| Surface electromyography | It is a record of the electrical activity associated with muscular contraction. The electromyography is recorded and the peak amplitude [maximal voluntary isometric contraction] is selected manually and recorded. | Change from baseline multifidus muscle activity at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | It is a standard questionnaire with questions regarding pain and the disabling effect on daily activities. Its score ranges from 0 to 100 (no disability to maximum disability). Cut off value score 9 shows sensitivity 62% and specificity 55%. | Change from baseline functional disability at 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle pain, Low Back Disorder, Exercise, Physical Therapy, Surface Electromyography