- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020668
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial
Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared almost exclusively toward medical-pharmacological area away from offering the patient the possibility of an interdisciplinary approach to their disease.
Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in rheumatic disease and improve their quality of life related to health.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Virendra Shekhawat, MA
- Phone Number: +91-8824260512
- Email: shekhawatvans21@gmail.com
Study Locations
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-
Rajasthan
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Sikar, Rajasthan, India
- Life Line Hospital
-
Contact:
- Deepika Ratan
- Phone Number: 9413623113
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients older than 18 years
- History of Rheumatoid Arthritis (RA) symptoms for less than 7 years
- Had RA by American College of Rheumatology (ACR) criteria
- ACR functional RA class I, II or III
- Hemoglobin more than 8g/dL without evidence of active bleeding
- Positive for rheumatoid factor (RF) or anti cyclic citrullinated protein
- standard conventional medicine were allowed within the approved dosage regimen
Exclusion Criteria:
- connective tissue disease
- any other alternative or complementary medicine with in last 3 months.
- corticosteroid, disease modifying medicines
- Poorly controlled diabetes, hypertension, hepatitis, cardiac disease, liver diseases, carcinoma, drug abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Physiotherapy
Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.
|
|
OTHER: Wait list control
Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain
Time Frame: Change from baseline in Numerical Scale Downie at 16 weeks
|
Change from baseline in Numerical Scale Downie at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: Change from Baseline in Short Form (SF) 36 at 16 weeks
|
Change from Baseline in Short Form (SF) 36 at 16 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional capacity
Time Frame: Change from baseline in Barthel Index at 16 weeks
|
Change from baseline in Barthel Index at 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Om Prakash Sharma, MBBS, Life Line Hospital, Sikar, India
Study record dates
Study Major Dates
Study Start
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mac/NMP 1210
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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