Back to resultsEfficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
Primary Purpose
Rheumatic Arthritis
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Physiotherapy
Wait list control
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Arthritis focused on measuring Pain, Functional capacity, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Life Line Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Physiotherapy
Wait list control
Arm Description
Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.
Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished.
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Quality of Life
Full Information
NCT ID
NCT02020668
First Posted
December 19, 2013
Last Updated
May 6, 2014
Sponsor
Macmillan Research Group UK
Collaborators
NMP Medical Research Institute, Warwick Research Services
1. Study Identification
Unique Protocol Identification Number
NCT02020668
Brief Title
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
Official Title
Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macmillan Research Group UK
Collaborators
NMP Medical Research Institute, Warwick Research Services
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Arthritis
Keywords
Pain, Functional capacity, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.
Arm Title
Wait list control
Arm Type
Other
Arm Description
Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Type
Other
Intervention Name(s)
Wait list control
Primary Outcome Measure Information:
Title
Pain
Time Frame
Change from baseline in Numerical Scale Downie at 16 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
Change from Baseline in Short Form (SF) 36 at 16 weeks
Other Pre-specified Outcome Measures:
Title
Functional capacity
Time Frame
Change from baseline in Barthel Index at 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virendra Shekhawat, MA
Phone
+91-8824260512
Email
shekhawatvans21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Macmillan Research Group
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Om Prakash Sharma, MBBS
Organizational Affiliation
Life Line Hospital, Sikar, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Life Line Hospital
City
Sikar
State/Province
Rajasthan
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepika Ratan
Phone
9413623113
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
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