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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2024-11-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Conventional physiotherapy

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

Intervention Type OTHER

Other Intervention Names

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central vertebral mobilizations followed by prone extension exercise

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No