NCT05997069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

August 10, 2023

Last Update Submit

November 10, 2024

Conditions

Keywords

lumbagoMackenziemovementhot packthermotherapygeneral stretching exercises.

Outcome Measures

Primary Outcomes (6)

  • 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.

    Baseline and after 15 week

  • 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.

    Baseline and after 15 week

  • 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.

    Baseline and after 15 week

  • 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.

    Baseline and after 15 week

  • 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.

    Baseline and after 15 week

  • 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.

    Baseline and after 15 week

Secondary Outcomes (2)

  • Functional disability on Oswestry Disability Index

    Baseline and after 15 week

  • Quality of life on World Health Organization Quality of Life Brief Version

    Baseline and after 15 week

Study Arms (2)

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

EXPERIMENTAL

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.

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

Conventional physiotherapy

ACTIVE COMPARATOR

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.

Other: Conventional physiotherapy

Interventions

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.

Also known as: central vertebral mobilizations followed by prone extension exercise
Posterior-anterior vertebral mobilizations followed by Prone press-up exercise

Traditionally used physiotherapy for the treatment of nonspecific low back pain (thermotherapy and general stretching exercises)

Conventional physiotherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 28359011BACKGROUND
  • 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.

    PMID: 28874980BACKGROUND
  • 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.

    PMID: 29805422BACKGROUND
  • 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.

    PMID: 20436236BACKGROUND
  • 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.

    PMID: 35296293BACKGROUND
  • 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.

    PMID: 32128535BACKGROUND
  • 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.

    PMID: 18258767BACKGROUND

MeSH Terms

Conditions

Low Back PainHyperthermia

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBody Temperature ChangesHeat Stress DisordersWounds and Injuries

Study Officials

  • Aftab Ahmed Mirza Baig, MSAPT, PhD

    Iqra University, North Campus, Karachi

    PRINCIPAL INVESTIGATOR
  • Syed Imran Ahmed, MBBS, FCPS

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to the type of treatment. It is essential for more subjective outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this research two groups of participants will receive different interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

August 21, 2023

Primary Completion

November 8, 2024

Study Completion

November 8, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations