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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616702
• Other study ID #: 2694
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: November 27, 2023

Study information

• Verified date: July 2023
• Source: Dow University of Health Sciences
• Contact: Shaiaza Masooma, DPT
• Phone: 03450726077
• Email: shaiazamasooma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 27, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Chronic Pain
• Low Back Pain
• Low Back Pain, Mechanical
• Lower Back Pain Chronic
• Mechanical Low Back Pain
• Pain, Back
• Pain, Chronic

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Pakistan	Dow Institute of Physical Medicine and Rehabilitation, DUHS.	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (change is being assessed)	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)"	Baseline and 6 weeks
Primary	Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)	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).	Baseline and 6 weeks
Secondary	Endurance test (change is being assessed) (mmHg)	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.	Baseline and 6 weeks
Secondary	Endurance test (change is being assessed) (hold time in seconds)	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.	Baseline and 6 weeks
Secondary	Lumbar Range of Motion (cm) (change is being assessed)	Modified- Modified Schober test For patients with low back discomfort, MMST method appears to be a good method for evaluating lumbar flexion and extension.	Baseline and 6 weeks