Efficacy of Physiotherapy on the Health and Quality of Li... | NCT02020668

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

NCT02020668

Sponsor

Macmillan Research Group UK

Status

Unknown status

Last Update Posted

May 7, 2014Estimated

Enrollment

82Estimated

Phase

Phase 2

Conditions

Rheumatic Arthritis

Interventions

Physiotherapy
Wait list control

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 24, 2013

First Posted Date

Dec 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2014

Last Update Posted Date

May 7, 2014Estimated

Name	Class
NMP Medical Research Institute	OTHER
Warwick Research Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other		Physiotherapy
Wait list control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain		Change from baseline in Numerical Scale Downie at 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life		Change from Baseline in Short Form (SF) 36 at 16 weeks

Other Outcomes

Measure	Description	Time Frame
Functional capacity		Change from baseline in Barthel Index at 16 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Virendra Shekhawat, MA	Contact	+91-8824260512		shekhawatvans21@gmail.com

Overall Officials

Name	Affiliation	Role
Neha Sharma, PhD	Macmillan Research Group	Study Director
Om Prakash Sharma, MBBS	Life Line Hospital, Sikar, India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Life Line Hospital		Sīkar	Rajasthan		India

Condition Browse Module

MeSH Terms

ID	Term
D012213	Rheumatic Fever
D010146	Pain

Ancestor Terms

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided