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

February 3, 2021 updated by: Aftab Ahmed Mirza Baig,DPT, MSAPT, University of Karachi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. 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.
  2. To determine the frequencies and statistical association of age, gender, body mass index (BMI) and occupation among participants in CLBP.
  3. 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.
  4. T determine the effects of bilateral, asymmetrical limbs PNF pattern exercises and Swiss ball exercises in participants with CLBP
  5. To compare the effects of bilateral, asymmetrical limbs PNF pattern exercises and Swiss ball exercises in participants with CLBP

Hypothesis:

  1. 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.
  2. 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 :

  1. 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
  2. Supine position: With a ball below the pelvis, knees bent, the ball press will be done with pelvis. 5 times, for 10 seconds hold.
  3. 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.
  4. 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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Aftab Ahmed Mirza Baig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A (PNF rhythmic initiation group )
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 )
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
ACTIVE_COMPARATOR: Group B (Swiss ball exercise group)
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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: Change from baseline pain intensity at 5 weeks.
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.
Time Frame: Change from baseline lumbar range of movement at 5 weeks.
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
Time Frame: Change from baseline multifidus muscle activity at 5 weeks
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
Time Frame: Change from baseline functional disability at 5 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Investigators

  • Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, University of Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2020

Primary Completion (ACTUAL)

December 15, 2020

Study Completion (ACTUAL)

January 17, 2021

Study Registration Dates

First Submitted

December 15, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (ACTUAL)

December 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Karachi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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