- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680493
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .
both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Foundation University College of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:-
- age between 30-60
- pateint with subacute and chronic low back pain at least last 6 months.
- pateint with active MTrps.
Exclusion Criteria:
- patient with fibromyalgia
- pregnant females
- patient with chronic diseases (osteoporosis, lungs disease and diabetes)
- patient with musculoskeletal injuries
- patient that are using any medication to relief pain like analgesic or muscle relaxants
- Any treatment for back pain in same period of research.
- patient having any radiculopathies or discogenic low back pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry needling
Total 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week
|
A filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point
Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min
|
|
Active Comparator: manual pressure release
Hot pack for 15 min then manual pressure release
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Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min
lengthens the muscle up to the increasing resistance, then gradually applies gentle pressure on MTrp until fingers feels a definite increase in tissue resistance (first barrier).
Pressure would maintain until clinician sense relief of tension
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: 4 weeks
|
visual analogue scale
|
4 weeks
|
|
functional disability
Time Frame: 4 weeks
|
functional disability will be measured through oswestry disability index
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2022/20
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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