- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616702
Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaiaza Masooma, DPT
- Phone Number: 03450726077
- Email: shaiazamasooma@gmail.com
Study Contact Backup
- Name: Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
- Phone Number: 03332209704
- Email: farhan.ishaque@duhs.edu.pk
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Recruiting
- Dow Institute of Physical Medicine and Rehabilitation, DUHS.
-
Contact:
- Shaiaza Masooma, DPT
- Phone Number: 03450726077
- Email: shaiazamasooma@gmail.com
-
Contact:
- Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
- Phone Number: 03332209704
- Email: farhan.ishaque@duhs.edu.pk
-
Principal Investigator:
- Shaiaza Masooma, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.
This study ARM will receive following therapies
|
Pressure Biofeedback Therapy
Exercising dosage:
Progressive Muscles Relaxation Technique
Exercising dosage:
Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins |
Active Comparator: Progressive Muscle Relaxation Technique + Thermotherapy
This study ARM will receive following therapies
|
Progressive Muscles Relaxation Technique
Exercising dosage:
Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (change is being assessed)
Time Frame: 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)"
|
Baseline and 6 weeks
|
Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)
Time Frame: 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).
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endurance test (change is being assessed) (mmHg)
Time Frame: 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.
|
Baseline and 6 weeks
|
Endurance test (change is being assessed) (hold time in seconds)
Time Frame: 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.
|
Baseline and 6 weeks
|
Lumbar Range of Motion (cm) (change is being assessed)
Time Frame: 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.
|
Baseline and 6 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Farhan I Khan, Ph.D, MBA, MSc.PT, DPT, Dow University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2694
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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