Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2022
CompletedFirst Submitted
Initial submission to the registry
October 29, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2023
CompletedJuly 10, 2023
July 1, 2023
1 year
October 29, 2022
July 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Endurance test (change is being assessed) (mmHg)
Baseline and 6 weeks
Endurance test (change is being assessed) (hold time in seconds)
Baseline and 6 weeks
Lumbar Range of Motion (cm) (change is being assessed)
Baseline and 6 weeks
Study Arms (2)
Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.
EXPERIMENTALThis study ARM will receive following therapies 1. Pressure Biofeedback Therapy 2. Progressive Muscles Relaxation Technique 3. Thermotherapy
Progressive Muscle Relaxation Technique + Thermotherapy
ACTIVE COMPARATORThis study ARM will receive following therapies 1. Progressive Muscles Relaxation Technique 2. Thermotherapy
Interventions
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 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
Eligibility Criteria
You may qualify if:
- Diagnosed and referred patients with non-specific low back pain for more than 3 months
- to 50 years
- Both genders
You may not qualify if:
- Any surgical history of lumbar spine
- Infections of the spine, malignancy
- Disc protrusion
- History of spinal fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dow Institute of Physical Medicine and Rehabilitation, DUHS.
Karachi, Sindh, 74200, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
Dow University of Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2022
First Posted
November 15, 2022
Study Start
October 15, 2022
Primary Completion
October 16, 2023
Study Completion
November 27, 2023
Last Updated
July 10, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share