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

May 6, 2014 updated by: Macmillan Research Group UK

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Sikar, Rajasthan, India
        • Life Line Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Physiotherapy
OTHER: 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

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

This is where you will find people and organizations involved with this study.

Sponsor

Macmillan Research Group UK

Collaborators

NMP Medical Research Institute
Warwick Research Services

Investigators

  • Principal Investigator: Om Prakash Sharma, MBBS, Life Line Hospital, Sikar, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 24, 2013

First Posted (ESTIMATE)

December 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

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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