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

Primary Purpose

Low Back Pain, Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Posterior-anterior vertebral mobilizations followed by Prone press-up exercise
Conventional physiotherapy
Sponsored by
Sindh Institute of Physical Medicine and Rehabilitation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring lumbago, Mackenzie, movement, hot pack, thermotherapy, general stretching exercises.

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sindh Institute Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Posterior-anterior vertebral mobilizations followed by Prone press-up exercise

Conventional physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity during walking on visual analogue scale
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
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
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
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
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
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.

Secondary Outcome Measures

Functional disability on Oswestry Disability Index
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
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.

Full Information

First Posted
August 10, 2023
Last Updated
August 21, 2023
Sponsor
Sindh Institute of Physical Medicine and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT05997069
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sindh Institute of Physical Medicine and Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Low-back Pain
Keywords
lumbago, Mackenzie, movement, hot pack, thermotherapy, general stretching exercises.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this research two groups of participants will receive different interventions.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to the type of treatment. It is essential for more subjective outcomes.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posterior-anterior vertebral mobilizations followed by Prone press-up exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional physiotherapy
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Posterior-anterior vertebral mobilizations followed by Prone press-up exercise
Other Intervention Name(s)
central vertebral mobilizations followed by prone extension exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Traditionally used physiotherapy for the treatment of nonspecific low back pain (thermotherapy and general stretching exercises)
Primary Outcome Measure Information:
Title
Pain intensity during walking on visual analogue scale
Description
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.
Time Frame
Baseline and after 15 week
Title
Pain intensity during standing on visual analogue scale
Description
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.
Time Frame
Baseline and after 15 week
Title
Pain intensity during sitting position on visual analogue scale
Description
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.
Time Frame
Baseline and after 15 week
Title
Lumbar flexion range of motion using Modified-Modified Schober test
Description
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.
Time Frame
Baseline and after 15 week
Title
Lumbar extension range of motion using Modified-Modified Schober test
Description
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.
Time Frame
Baseline and after 15 week
Title
Isometric endurance of back extensor muscles using prone isometric chest raise test
Description
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.
Time Frame
Baseline and after 15 week
Secondary Outcome Measure Information:
Title
Functional disability on Oswestry Disability Index
Description
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.
Time Frame
Baseline and after 15 week
Title
Quality of life on World Health Organization Quality of Life Brief Version
Description
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.
Time Frame
Baseline and after 15 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aftab Ahmed Mirza Baig, MSAPT, PhD
Phone
03002739920
Email
ab.dptrm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT, PhD
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syed Imran Ahmed, MBBS, FCPS
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Sindh Institute Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT, PhD
Phone
03002739920
Email
ab.dptrm@gmail.com
First Name & Middle Initial & Last Name & Degree
Syed Imran Ahmed, MBBS, FCPS
Phone
03002120661
Email
imran.ahmed@sipmr.edu.pk
First Name & Middle Initial & Last Name & Degree
Faizan Siddiqui, MSAPT
First Name & Middle Initial & Last Name & Degree
Urooj Khan, MSAPT
First Name & Middle Initial & Last Name & Degree
Zaigham Rasool, MScPT
First Name & Middle Initial & Last Name & Degree
Shumaila Ismail, MSAPT

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
28359011
Citation
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.
Results Reference
background
PubMed Identifier
28874980
Citation
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.
Results Reference
background
PubMed Identifier
29805422
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.
Results Reference
background
PubMed Identifier
20436236
Citation
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.
Results Reference
background
PubMed Identifier
35296293
Citation
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.
Results Reference
background
PubMed Identifier
32128535
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.
Results Reference
background
PubMed Identifier
18258767
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.
Results Reference
background

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

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