Clinical trial NCT05997069: Effects of Posterior-anterior Vertebral Mobilization Followed by Prone Press-up Exercise in Nonspecific Low Back Pain
Official title: Effects of Posterior-anterior Vertebral Mobilization Followed by Prone Press-up Exercise in Nonspecific Low Back Pain- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Low-back Pain
Keywords: lumbago
Mackenzie
movement
hot pack
thermotherapy
general stretching exercises.
Lead sponsor: Sindh Institute of Physical Medicine and Rehabilitation
Sponsor class: OTHER
Collaborators: name: Dow University of Health Sciences
name: Sindh Institute of Physical Medicine and Rehabilitation
name: IQRA University
First posted: 2023-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this research two groups of participants will receive different interventions.
Primary purpose: TREATMENT

Brief summary: Despite advances in intervention, many patients presenting with nonspecific low back pain (NSLBP) fail to have recovery from symptoms and activity limitation. Evidence suggests that interventions commonly used by physical therapists, may be effective for some but not all subsets of people with low back pain. Posterior anterior vertebral mobilizations (PAVMs) followed by prone press up (PPU) exercise are commonly used in clinical practice without a firm evidence. Research has shown this intervention decreases nonspecific low back pain on immediate effects but there is still limitation.The objective of this study is to determine the effects of posterior anterior vertebral mobilization followed by prone press-up exercise in comparison to conventional physiotherapy in nonspecific low back pain. The hypothesis is that the PAVMs followed by PPU exercise is more effective as compared to conventional physiotherapy to improve pain, lumbar range of motion, disability and quality of life in NSLBP. So, a randomized controlled trial will be conducted at Sindh Institute of Physical Medicine and Rehabilitation. One hindered and twenty patients with 18-40 years old having NSLB will be included on the basis of non-probability and purposive sampling technique and consent will be taken. Participants will be allocated into two groups through computer random sampling software. Experimental group will receive posterior-anterior vertebral mobilization followed by prone press up exercise and control group will receive conventional therapy (thermotherapy with general stretching exercises). All participants will be assessed using assessment form. After taking demo-graphical information, pain (in standing, sitting and walking), lumbar flexion and extension, functional disability and quality of life will be assessed before and after the treatment. All the data will be analysed for descriptive and inferential analysis.

Detailed description: Initially, sample size of 38 was calculated through open epi software version 3.01 with 95% confidence interval and 80% power of test with post-test VAS mean (4.6) and standard deviation (1.2), in experimental group 17 and post-test VAS mean (3.6) and standard deviation (0.94) in control group on the basis of previous literature. Due to the low sample size at least 50 subjects per group were considered first. After including drop rate of 20%, 60 subjects per group will be considered with sample size of 120 participants having NSLBP. A maximum drop-out rate of 20% is assumed. All the data will be kept confidential. The privacy of all patients will be maintained. The patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be monitored by Institutional Review Board of the same institute. Data will be analysed using SPSS 23 version. Mean ± SD will be calculated of quantitative variables like age. Frequency and percentage will be calculated for qualitative variables. Intention to treat analysis will be used. The intra-group and inter-group analysis will be performed with two way repeated measure ANOVA. The p-value of 0.025 will be considered as level of significance.

Eligibility criteria: Inclusion Criteria:

* Non-specific low back pain for more than 6 weeks.
* Moderate intensity pain (3.5 -7.4 cm on Visual analogue scale)

Exclusion Criteria:

* Subject whose current symptoms of low back pain provoke, or increase, and/or peripheralize (ie, pain reported to move from the midline laterally, or to the buttocks, and/or lower extremity) with lumbar forward bending and prolonged sitting to a greater degree than with lumbar backward bending, or walking
* Any history of trauma, fracture or surgical procedure of the lumbar spine.
* Subjects administered epidural injections.
* Low back pain due to specific pathology.
* Any clinical condition that contraindicated physiotherapy intervention.
* Subjects with neurological deficits (like stroke, Parkinsonism).

Primary outcomes:
measure: Pain intensity during walking on visual analogue scale
timeFrame: Baseline and after 15 week
measure: Pain intensity during standing on visual analogue scale
timeFrame: Baseline and after 15 week
measure: Pain intensity during sitting position on visual analogue scale
timeFrame: Baseline and after 15 week
measure: Lumbar flexion range of motion using Modified-Modified Schober test
timeFrame: Baseline and after 15 week
measure: Lumbar extension range of motion using Modified-Modified Schober test
timeFrame: Baseline and after 15 week
measure: Isometric endurance of back extensor muscles using prone isometric chest raise test
timeFrame: Baseline and after 15 week
Secondary outcomes:
measure: Functional disability on Oswestry Disability Index
timeFrame: Baseline and after 15 week
measure: Quality of life on World Health Organization Quality of Life Brief Version
timeFrame: Baseline and after 15 week
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Iqra University, North Campus, Karachi
name: Aftab Ahmed Mirza Baig, MSAPT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Syed Imran Ahmed, MBBS, FCPS
role: STUDY_CHAIR
References:
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citation: Baig AAM, Ahmed SI, Ali SS, Rahmani A, Siddiqui F. Role of posterior-anterior vertebral mobilization versus thermotherapy in non specific lower back pain. Pak J Med Sci. 2018 Mar-Apr;34(2):435-439. doi: 10.12669/pjms.342.12402.
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citation: Mehyar F, Santos M, Wilson SE, Staggs VS, Sharma NK. Effect of Grade III Lumbar Mobilization on Back Muscles in Chronic Low Back Pain: A Randomized Controlled Trial. J Allied Health. 2020 Spring;49(1):20-28.
citation: Powers CM, Beneck GJ, Kulig K, Landel RF, Fredericson M. Effects of a single session of posterior-to-anterior spinal mobilization and press-up exercise on pain response and lumbar spine extension in people with nonspecific low back pain. Phys Ther. 2008 Apr;88(4):485-93. doi: 10.2522/ptj.20070069. Epub 2008 Feb 7.