Rheumatic ArthritisPhase 2NCT02020668
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
A Phase 2 study testing Physiotherapy in people with Rheumatic Arthritis, run by Macmillan Research Group UK at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatic Arthritis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndia
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatic Arthritis
- Being tested
- Physiotherapy, Wait list control
- Keywords
- Pain, Functional capacity, Quality of Life
- Medical subject headings
- Rheumatic Fever, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Wait list controlOther
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education. Receives: Other: Physiotherapy |
| Wait list control | Other | Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished. Receives: Other: Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: Change from baseline in Numerical Scale Downie at 16 weeks
Secondary outcomes (1)
Quality of Life
Measured: Change from Baseline in Short Form (SF) 36 at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute, Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Macmillan Research GroupOm Prakash Sharma, MBBS, Principal investigator, Life Line Hospital, Sikar, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020668
- Sponsor's protocol ID
- Mac/NMP 1210
- Status last verified
- May 2014
- First submitted
- 19 Dec 2013
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT02020668
- Acronym / sponsor ID
- Mac/NMP 1210
- Conditions
- Rheumatic Arthritis
- Keywords
- Pain, Functional capacity, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute, Warwick Research Services
- Study start
- May 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: PhysiotherapyPhysiotherapy included joint protection strategies, performance of therapeutic exercises and patient education. |
| Wait list control | Other | Other: Wait list controlWait list control received standard care and were invited to join the physiotherapy once intervention period is finished. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy | Other | Physiotherapy |
| Wait list control | Other | Wait list control |
Primary outcome
Pain
Time frame: Change from baseline in Numerical Scale Downie at 16 weeks
1 secondary outcome
Quality of Life
Time frame: Change from Baseline in Short Form (SF) 36 at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
Related trials for Rheumatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD study director
Macmillan Research Group
Om Prakash Sharma, MBBS principal investigator
Life Line Hospital, Sikar, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physiotherapy in people with Rheumatic Arthritis, run by Macmillan Research Group UK at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virendra Shekhawat, MA (+91-8824260512, shekhawatvans21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from baseline in Numerical Scale Downie at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.