NCT04206137

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

Completed NA Last updated 8 February 2021

What this trial tests

NA trial testing Group A (PNF rhythmic initiation group ) in Low Back Pain in 150 participants. Completed in 17 January 2021.

Timeline

3 March 2020

Primary endpoint
15 December 2020

17 January 2021

Quick facts

Lead sponsor	University of Karachi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	3 March 2020
Primary completion	15 December 2020
Estimated completion	17 January 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Group A (PNF rhythmic initiation group )
• Group B (Swiss ball exercises)

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

University of Karachi

Who can join

Adults 18 to 40, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bilateral Asymmetrical Limb Proprioceptive Neuromuscular Facilitation Effects on Pain, Multifidus Activity, Range of Motion, and Disability in Low Back Pain: A Randomized Controlled Trial.
   Baig AAM, Ansari B. · · 2022 · cited 3× · PMID 37294220 · DOI 10.1016/j.jmpt.2023.04.005
2. Association of demographics, lumbar active range of motion and disability in chronic low back: a baseline data analysis of a randomized controlled trial from Pakistan.
   Baig AAM, Ansari B, Ahmed SI, Ishaque F, et al · · 2024 · cited 2× · PMID 38909184 · DOI 10.1186/s12891-024-07613-9