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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02020668
Recruitment Status : Unknown
Verified May 2014 by Macmillan Research Group UK.
Recruitment status was:  Not yet recruiting
First Posted : December 25, 2013
Last Update Posted : May 7, 2014
NMP Medical Research Institute
Warwick Research Services
Information provided by (Responsible Party):
Macmillan Research Group UK

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.

Condition or disease Intervention/treatment Phase
Rheumatic Arthritis Other: Physiotherapy Other: Wait list control Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial
Study Start Date : May 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Physiotherapy
Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.
Other: Physiotherapy
Wait list control
Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished.
Other: Wait list control

Primary Outcome Measures :
  1. Pain [ Time Frame: Change from baseline in Numerical Scale Downie at 16 weeks ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Change from Baseline in Short Form (SF) 36 at 16 weeks ]

Other Outcome Measures:
  1. Functional capacity [ Time Frame: Change from baseline in Barthel Index at 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02020668

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Contact: Virendra Shekhawat, MA +91-8824260512

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Life Line Hospital
Sikar, Rajasthan, India
Contact: Deepika Ratan    9413623113      
Sponsors and Collaborators
Macmillan Research Group UK
NMP Medical Research Institute
Warwick Research Services
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Study Director: Neha Sharma, PhD Macmillan Research Group
Principal Investigator: Om Prakash Sharma, MBBS Life Line Hospital, Sikar, India
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Responsible Party: Macmillan Research Group UK Identifier: NCT02020668    
Other Study ID Numbers: Mac/NMP 1210
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Keywords provided by Macmillan Research Group UK:
Functional capacity
Quality of Life
Additional relevant MeSH terms:
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Rheumatic Fever
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections