Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient

Rheumatic Arthritis Clinical Trial

Official title:

Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02020668
• Other study ID #: Mac/NMP 1210
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 19, 2013
• Last updated: May 6, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Macmillan Research Group UK
• Contact: Virendra Shekhawat, MA
• Phone: +91-8824260512
• Email: shekhawatvans21[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Rheumatic Arthritis
• Rheumatic Diseases
• Rheumatic Fever

Intervention

Other:
• Physiotherapy

• Wait list control

Locations

Country	Name	City	State
India	Life Line Hospital	Sikar	Rajasthan

Sponsors (3)

Lead Sponsor	Collaborator
Macmillan Research Group UK	NMP Medical Research Institute, University of Warwick

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional capacity		Change from baseline in Barthel Index at 16 weeks	No
Primary	Pain		Change from baseline in Numerical Scale Downie at 16 weeks	No
Secondary	Quality of Life		Change from Baseline in Short Form (SF) 36 at 16 weeks	No