Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain

Not Applicable

Recruiting

• Conditions: CLBP - Chronic Low Back Pain; Low Back Pain, Mechanical; Chronic Low-back Pain; Mechanical Low Back Pain; Low Back Pain; Pain, Chronic; Lower Back Pain Chronic; Pain, Back
• Interventions: Other: Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy; Other: Progressive Muscles Relaxation + thermotherapy

• Registration Number: NCT05616702
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

Low back pain is common MSK disease with prevalence of 60 to 70 percent. Patients with low back discomfort are typically treated conservatively by physical therapists. Progressive muscles relaxation technique has been shown in several studies to reduce chronic back pain and increase flexibility. pressure biofeedback therapy works on Intra abdominal pressure.it helps to alleviate compression on lumbar spine and support the adjacent lumbar spine.The aim of this randomized controlled trial is to determine the effectiveness of pressure biofeedback training (Pr.BFB) in combination with progressive muscles relaxation technique (PMR) \& progressive muscles relaxation training alone on pain, disability, ROM \& endurance of muscles among nonspecific chronic low back pain patients.

Detailed Description

A randomized clinical trial will be carried out in the Physical Therapy O.P.D of Dow hospital Karachi. Collection of data will commence right after approval of synopsis from Dow IRB. A sample of 70 NSCLBP patients calculated by using mean \& SD of visual analogue scale in abdominal stabilisation training with Pr.BFB stabilizer was 2.69 ±0.93 and Progressive muscular Relaxation VAS was 3.863 ±2.03. Before being recruited into the experiment, patients will be screened to ensure that they meet the inclusion criteria. Pain rating scale and Roland-Morris questionnaire will be used to gather data after explaining the research goals to patients and obtaining formal consent from them. Patients will be divided into 2 interventional groups by simple random sampling, with 35 patients in each group. Experimental group will be received Pressure Bio-Feedback Therapy in combination with PMR Technique and Thermotherapy. The Control group, on the other hand, will be received a combination of Progressive Muscle Relaxation Technique and Thermotherapy for non-specific CLBP. It will be a 6-weeks intervention plan with 3 sessions per week (40-minutes each). Assessor will be blinded to the treatment. Roland Morris Low back pain and disability questionnaire (RMQ) and the NPR Scale will be used as primary outcome measures. Secondary outcomes will be determined by modified-modified Schober test for assessing lumbar ROM \& Pressure Biofeedback Stabilizer unit helps to gauge muscular endurance.

Study Timeline

• Study Start: 2022-10-15
• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10
• Primary Completion: 2023-10-16
• Study Completion: 2023-11-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Diagnosed and referred patients with non-specific low back pain for more than 3 months
• 30 to 50 years
• Both genders

Exclusion Criteria

• Any surgical history of lumbar spine
• Infections of the spine, malignancy
• Disc protrusion
• History of spinal fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.	Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy	This study ARM will receive following therapies 1. Pressure Biofeedback Therapy 2. Progressive Muscles Relaxation Technique 3. Thermotherapy
Progressive Muscle Relaxation Technique + Thermotherapy	Progressive Muscles Relaxation + thermotherapy	This study ARM will receive following therapies 1. Progressive Muscles Relaxation Technique 2. Thermotherapy

Primary Outcome Measures

Name	Time	Method
Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)	Baseline and 6 weeks	A standard tool called the "Roland-Morris Disability Questionnaire" consists of 24 items about a person's disabilities and pain perceptions The patient is told to draw a mark beside each element that corresponds to him or her. Sum of marked items will determine a patient's score. The scoring ranges from 0 - 24. (No to extreme disability).
Numeric Pain Rating Scale (change is being assessed)	Baseline and 6 weeks	On a scale of 0 to 10, "Please indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)"

Secondary Outcome Measures

Name	Time	Method
Endurance test (change is being assessed) (mmHg)	Baseline and 6 weeks	For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.
Lumbar Range of Motion (cm) (change is being assessed)	Baseline and 6 weeks	Modified- Modified Schober test For patients with low back discomfort, MMST method appears to be a good method for evaluating lumbar flexion and extension.
Endurance test (change is being assessed) (hold time in seconds)	Baseline and 6 weeks	For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.

Trial Locations

Locations (1)

Dow Institute of Physical Medicine and Rehabilitation, DUHS.; 🇵🇰 Karachi, Sindh, Pakistan