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
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 25, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 7, 2014
May 1, 2014
4 months
December 19, 2013
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Change from baseline in Numerical Scale Downie at 16 weeks
Secondary Outcomes (1)
Quality of Life
Change from Baseline in Short Form (SF) 36 at 16 weeks
Other Outcomes (1)
Functional capacity
Change from baseline in Barthel Index at 16 weeks
Study Arms (2)
Physiotherapy
EXPERIMENTALPhysiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.
Wait list control
OTHERWait list control received standard care and were invited to join the physiotherapy once intervention period is finished.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Macmillan Research Group UKlead
- NMP Medical Research Institutecollaborator
- Warwick Research Servicescollaborator
Study Sites (1)
Life Line Hospital
Sīkar, Rajasthan, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neha Sharma, PhD
Macmillan Research Group
- PRINCIPAL INVESTIGATOR
Om Prakash Sharma, MBBS
Life Line Hospital, Sikar, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
December 25, 2013
Study Start
May 1, 2014
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
May 7, 2014
Record last verified: 2014-05