Effects of Posterior-anterior Vertebral Mobilization Followed by Prone Press-up Exercise in Nonspecific Low Back Pain

• ClinicalTrials.gov Identifier: NCT05997069
• Recruitment Status: Recruiting
• First Posted: August 18, 2023
• Last Update Posted: March 8, 2024
• Sponsor: Sindh Institute of Physical Medicine and Rehabilitation
• Information provided by (Responsible Party): Dr. Aftab Ahmed Mirza Baig, Sindh Institute of Physical Medicine and Rehabilitation

Tracking Information

• First Submitted Date: August 10, 2023
• First Posted Date: August 18, 2023
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: August 21, 2023
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 10, 2023)

• Pain intensity during walking on visual analogue scale [ Time Frame: Baseline and after 15 week ]
  It is a self-administered 10 cm scale (line) where 0 cm suggests no pain and 10 suggests most excruciating pain. It will be used to asses pain in walking. Increase in score suggests increase in pain and decrease in score suggests decrease in pain.
• Pain intensity during standing on visual analogue scale [ Time Frame: Baseline and after 15 week ]
  It is a self-administered 10 cm scale (line) where 0 cm suggests no pain and 10 suggests most excruciating pain. It will be used to asses pain in standing. Increase in score suggests increase in pain and decrease in score suggests decrease in pain.
• Pain intensity during sitting position on visual analogue scale [ Time Frame: Baseline and after 15 week ]
  It is a self-administered 10 cm scale (line) where 0 cm suggests no pain and 10 suggests most excruciating pain. It will be used to asses pain in sitting. Increase in score suggests increase in pain and decrease in score suggests decrease in pain.
• Lumbar flexion range of motion using Modified-Modified Schober test [ Time Frame: Baseline and after 15 week ]
  Both posterior superior iliac spines (PSIS) of participant are marked with body marker. A midline point on sacrum (lower mark) between those two PSIS are localized and marked. Then the upper mark is marked at 15 cm above the midline point at sacrum. The distance between the marks will be measured after bending forward. The length is subtracted from 15 cm to indicate lumbar flexion range of motion. Increase in score suggests increase and decrease in score suggests decrease in flexion range of motion.
• Lumbar extension range of motion using Modified-Modified Schober test [ Time Frame: Baseline and after 15 week ]
  Both posterior superior iliac spines (PSIS) of participant are marked with body marker. A midline point on sacrum (lower mark) between those two PSIS are localized and marked. Then the upper mark is marked at 15 cm above the midline point at sacrum. The distance between the marks will be measured after bending backward. The change in distance between those marks indicates the lumbar extension ROM. Decrease in score suggests increase in extension and increase in score suggests decrease in extension range of motion.
• Isometric endurance of back extensor muscles using prone isometric chest raise test [ Time Frame: Baseline and after 15 week ]
  The test consists of assessing how many seconds the participant can keep the sternum off the floor while placed prone with the arms along the body. A small pillow is placed under the iliac crest to decrease the lumbar lordosis. The subject is asked to maintain the position for as long as possible, not exceeding a 5 min time limit.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 10, 2023)

• Functional disability on Oswestry Disability Index [ Time Frame: Baseline and after 15 week ]
  Oswestry Disability Index questionnaire 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). decrease in score suggests decrease in disability and increase in score suggests increase in disability.
• Quality of life on World Health Organization Quality of Life Brief Version [ Time Frame: Baseline and after 15 week ]
  It is a self-administered questionnaire. The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) addresses four quality of life domains: physical health, psychological health, social relationships and environment. The scoring is done by summing all the points of all 4 domains and transforming into 0-100 scale, where higher score means high Qquality of life and low score means low quality of life.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In this research two groups of participants will receive different interventions.

Masking: Single (Outcomes Assessor)
Masking Description:

The outcome assessor will be blinded to the type of treatment. It is essential for more subjective outcomes.

Primary Purpose: Treatment

Condition

• Low Back Pain
• Chronic Low-back Pain

Intervention

• Other: Posterior-anterior vertebral mobilizations followed by Prone press-up exercise

  Posterior-anterior vertebral mobilizations of the lumbar spine are achieved by applying a force on to a spinous process in a posteroanterior direction (Back to front).

  Prone press-up exercise is started in the prone position (lying on stomach) on a flat surface. Participant keeps hands underneath the shoulders then press up his or her upper body while trying to keep the hips on the floor.

  Other Name: central vertebral mobilizations followed by prone extension exercise
• Other: Conventional physiotherapy
  Traditionally used physiotherapy for the treatment of nonspecific low back pain (thermotherapy and general stretching exercises)

Study Arms

• Experimental: Posterior-anterior vertebral mobilizations followed by Prone press-up exercise
  In experimental group the application of posterior-anterior vertebral mobilizations (three bouts of 40 seconds oscillations will be applied at the rate of approximately 3 oscillations per second and at the highest amplitude when tolerated without the reproduction of symptoms) followed by Prone press-up exercise (Ten repetitions will be performed with 5 second hold. on successful completion of 10 repetitions without increase in discomfort, second and third sets will be performed) will given.
  Intervention: Other: Posterior-anterior vertebral mobilizations followed by Prone press-up exercise
• Active Comparator: Conventional physiotherapy
  In conventional physiotherapy, the application of thermotherapy on lower back region (continuous with duration of 10 minutes) by means of hot pack followed by general stretching exercises (Lower Back, Hamstring, Tensor Fasciae Latae Stretching with two sets and ten repetitions) will given.Thirty second rests will be taken every five minutes during the stretching session.
  Intervention: Other: Conventional physiotherapy

Publications *

• Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.
• Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
• 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.
• Beattie PF, Arnot CF, Donley JW, Noda H, Bailey L. The immediate reduction in low back pain intensity following lumbar joint mobilization and prone press-ups is associated with increased diffusion of water in the L5-S1 intervertebral disc. J Orthop Sports Phys Ther. 2010 May;40(5):256-64. doi: 10.2519/jospt.2010.3284.
• Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Hanif A. Effects of non-surgical decompression therapy in addition to routine physical therapy on pain, range of motion, endurance, functional disability and quality of life versus routine physical therapy alone in patients with lumbar radiculopathy; a randomized controlled trial. BMC Musculoskelet Disord. 2022 Mar 16;23(1):255. doi: 10.1186/s12891-022-05196-x.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 10, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Aftab Ahmed Mirza Baig, MSAPT, PhD; 03002739920; dr.aftab@iqra.edu.pk

• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05997069
• Other Study ID Numbers: SindhIPMR
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in physical medicine rehabilitation and low back pain.

• Current Responsible Party: Dr. Aftab Ahmed Mirza Baig, Sindh Institute of Physical Medicine and Rehabilitation
• Original Responsible Party: Same as current
• Current Study Sponsor: Sindh Institute of Physical Medicine and Rehabilitation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, PhD; Iqra University, North Campus, Karachi
• Study Chair: Syed Imran Ahmed, MBBS, FCPS; Sindh Institute of Physical Medicine and Rehabilitation

• PRS Account: Sindh Institute of Physical Medicine and Rehabilitation
• Verification Date: March 2024