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

NCT ID: NCT05616702

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-11-27

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.

Conditions

Low Back Pain, Mechanical; Chronic Low-back Pain; Mechanical Low Back Pain; Lower Back Pain Chronic; Low Back Pain; CLBP - Chronic Low Back Pain; Pain, Chronic; Pain, Back

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.

This study ARM will receive following therapies

1. Pressure Biofeedback Therapy

2. Progressive Muscles Relaxation Technique

3. Thermotherapy

Group Type: EXPERIMENTAL

Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy

Intervention Type: OTHER

Pressure Biofeedback Therapy

• prone position, abdominal drawing in for 10 sec. (PBU inflated to 70 mmHg)
• Supine position with flexed knees, abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg)
• Progress to leg loading in supine abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg)

Exercising dosage:

• Duration: 15 mins
• Frequency: 3 sessions/ week
• Repetitions: 3 sets of 15 reps

Progressive Muscles Relaxation Technique

• Tense => five seconds and,
• release => ten seconds (Each group of muscle)
• 2 circuits daily

Exercising dosage:

• Duration: 15 mins
• Frequency: weekly 3 sessions; for 6 weeks
• Repetitions: 2 reps (cycles)

Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins

Progressive Muscle Relaxation Technique + Thermotherapy

This study ARM will receive following therapies

1. Progressive Muscles Relaxation Technique

2. Thermotherapy

Group Type: ACTIVE_COMPARATOR

Progressive Muscles Relaxation + thermotherapy

Intervention Type: OTHER

Progressive Muscles Relaxation Technique

• Tense => five seconds and,
• release => ten seconds (Each group of muscle)
• 2 circuits daily

Exercising dosage:

• Duration: 15 mins
• Frequency: weekly 3 sessions; for 6 weeks
• Repetitions: 2 reps (cycles)

Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins

Interventions

Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy

Pressure Biofeedback Therapy

• prone position, abdominal drawing in for 10 sec. (PBU inflated to 70 mmHg)
• Supine position with flexed knees, abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg)
• Progress to leg loading in supine abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg)

Exercising dosage:

• Duration: 15 mins
• Frequency: 3 sessions/ week
• Repetitions: 3 sets of 15 reps

Progressive Muscles Relaxation Technique

• Tense => five seconds and,
• release => ten seconds (Each group of muscle)
• 2 circuits daily

Exercising dosage:

• Duration: 15 mins
• Frequency: weekly 3 sessions; for 6 weeks
• Repetitions: 2 reps (cycles)

Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins

Intervention Type: OTHER

Progressive Muscles Relaxation + thermotherapy

Progressive Muscles Relaxation Technique

• Tense => five seconds and,
• release => ten seconds (Each group of muscle)
• 2 circuits daily

Exercising dosage:

• Duration: 15 mins
• Frequency: weekly 3 sessions; for 6 weeks
• Repetitions: 2 reps (cycles)

Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shaiaza Masooma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farhan I Khan, Ph.D, MBA, MSc.PT, DPT

Role: STUDY_DIRECTOR

Dow University of Health Sciences

Locations

Dow Institute of Physical Medicine and Rehabilitation, DUHS.

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Shaiaza Masooma, DPT

Role: CONTACT

shaiazamasooma@gmail.com

03450726077

Farhan I Khan, Ph.D, MBA, MSc.PT, DPT

Role: CONTACT

farhan.ishaque@duhs.edu.pk

03332209704

Facility Contacts

Shaiaza Masooma, DPT

Role: primary

shaiazamasooma@gmail.com

03450726077

Farhan I Khan, Ph.D, MBA, MSc.PT, DPT

Role: backup

farhan.ishaque@duhs.edu.pk

03332209704

Other Identifiers

2694

Identifier Type: -

Identifier Source: org_study_id