- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07714031
Comparative Effects of 3-Dimensional Articular and Soft Tissue Myofascial Release Approach in Patients With Overuse Syndrome of Wrist Joint
Overuse syndrome or RSI is challenging condition among clinicians now a days. These are MSK disorders which are related to bones, muscles and tendons peripheral nerve entrapment and vascular changes. These MSK disorders commonly effects back, neck and upper limbs although it least effect lower limbs. These problems occur from repetitive movements, ergonomic hazards, awkward postures and work related problems. This study aims to assess the comparative effects of 3 dimensional articular myofascial release approach and soft tissue myofascial release approach in patients with overuse syndrome of wrist joint. A randomized controlled trial will be conducted age between 20-55 years, both male and female genders will be included diagnosed with overuse syndrome of wrist. Diagnosis will be made on the basis of diagnostic criteria which will include tenderness present in intrinsic muscles and pain in radial ligament of wrist. Participants will be chosen through consecutive sampling.
Each participant will sign a consent form before taking part in the study. According to sample size 46 participants will be divided into two groups. Each group will include 23 participants which will be divided through lottery method. Both groups will receive baseline treatment which will include hot-pack for 15 minutes. Group a will be treated with articular fascial release and group b will be treated with soft tissue release for 3 sessions per week, for 3 weeks. After therapy session both groups will perform wrist rom exercises including wrist flexion, extension, radial and ulnar deviation 5 repetitions each. Outcome measuring tools will be numeric pain rating scale (NPRS) for pain, disabilities of arm, shoulder and hand (DASH) for functional disability, patient rated wrist evaluation (PRWE) specifically wrist functions evaluation and goniometer for range of motion. Data will be investigated through SPSS.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Rubina Zulfqar
- Phone Number: +923414291664
- Email: drrubinazulfqar355@gmail.com
Study Locations
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 38000
- Recruiting
- Dr Rubina Zulfqar
-
Contact:
- Dr Rubina Zulfqar
- Phone Number: +923414291664
- Email: drrubinazulfqar355@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients between 20-55 years of age
- Male and female (Antohe and Alshana, 2024)
- Participants involved in repetitive movements of hands e.g computer workers ( 2026/3/4
- Patients who have gradual onset of pain not sudden
- Reproduction of pain with wrist flexion, extension, ulnar and radial deviation (Van Der Molen HF et al., 2021)
- Patients with >10% reduced ROM of wrist joint as compared to contralateral side (Reissner et al., 2019)
- Participants who will willing to participate
Exclusion Criteria:Specific disease of wrist e.g RA, gout, infection (Ferguson et al., 2019a)
- Patients with traumatic wrist pathology (such as scaphoid fracture, distal radius fracture) (Ferguson et al., 2019a)
- Neuropathic compromise patients such as diabetic neuropathy, CTS
- Open wound
- Suspected or confirmed malignancy in wrist joint
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: 3- dimensional Articular fascial release approach
|
Hot pack for 15 mins.3-
dimensional Articular fascial release approach
|
|
Experimental: 3 Dimensional soft tissue release approach
|
Hot pack for 15 mins. 3 Dimensional soft tissue release approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 3 weeks
|
Pain Intensity will be measured by using the Numeric Pain Rating Scale, the patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).NPRS scale consists of 11 points in which 0 is no pain while 10 is worst pain.
|
3 weeks
|
|
Range of Motion
Time Frame: 3 weeks
|
Range of Motion will be measured by using Goniometry the improvement in ROM shows good results.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional disability
Time Frame: 3 weeks
|
Functional disability will be measured by using The Disabilities of Arm, Shoulder and Hand (DASH) and Patient-rated wrist evaluation form (PRWE).
The DASH questionnaire is consists of thirty items which asses the physical function and symptoms.
It involve five options for response of each item.
Ultimate score is calculated through the formula below: DASH score = {(sum of n responses)-1}*25, n=number of complete responses, the highest score showed improvement.
While The PRWE is a self administrated questionnaire which is patient specific which consist of 15 items.
It was designed for measurement of activities of daily living of wrist pain and disability and consist of 2 subscales; pain and function.A score of 100 represent the worst functional score while the score 0 indicate no disability.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- TUF/EIRB/177/26
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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