Effects of Posterior-anterior Vertebral Mobilization Followed by Prone Press-up Exercise in Nonspecific Low Back Pain
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ClinicalTrials.gov Identifier: NCT05997069 |
Recruitment Status :
Recruiting
First Posted : August 18, 2023
Last Update Posted : March 8, 2024
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain Chronic Low-back Pain | Other: Posterior-anterior vertebral mobilizations followed by Prone press-up exercise Other: Conventional physiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
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 |
Official Title: | Effects of Posterior-anterior Vertebral Mobilization Followed by Prone Press-up Exercise in Nonspecific Low Back Pain- a Randomized Controlled Trial |
Actual Study Start Date : | August 21, 2023 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
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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.
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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 |
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.
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Other: Conventional physiotherapy
Traditionally used physiotherapy for the treatment of nonspecific low back pain (thermotherapy and general stretching exercises) |
- 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.
- 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.
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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997069
Contact: Aftab Ahmed Mirza Baig, MSAPT, PhD | 03002739920 | dr.aftab@iqra.edu.pk |
Pakistan | |
Sindh Institute Physical Medicine and Rehabilitation | Recruiting |
Karachi, Sindh, Pakistan, 74200 | |
Contact: Aftab Ahmed Mirza Baig, MSAPT, PhD 03002739920 dr.aftab@iqra.edu.pk | |
Contact: Syed Imran Ahmed, MBBS, FCPS 03002120661 imran.ahmed@sipmr.edu.pk | |
Sub-Investigator: Faizan Siddiqui, MSAPT | |
Sub-Investigator: Urooj Khan, MSAPT | |
Sub-Investigator: Zaigham Rasool, MScPT | |
Sub-Investigator: Shumaila Ismail, MSAPT |
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 |
Responsible Party: | Dr. Aftab Ahmed Mirza Baig, Senior Physiotherapist, Sindh Institute of Physical Medicine and Rehabilitation |
ClinicalTrials.gov Identifier: | NCT05997069 |
Other Study ID Numbers: |
SindhIPMR |
First Posted: | August 18, 2023 Key Record Dates |
Last Update Posted: | March 8, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
lumbago Mackenzie movement |
hot pack thermotherapy general stretching exercises. |
Back Pain Low Back Pain Pain Neurologic Manifestations |