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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT02553005 |
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Date of registration:
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12/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Effect of Acupuncture on Hand Pain, Functional Deficits and Health Related Quality of Life in Patients With Rheumatoid Arthritis
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Scientific title:
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Evaluation of the Effect of Acupuncture on Hand Pain, Functional Deficits and Health Related Quality of Life in Patients With Rheumatoid Arthritis - A Multicenter, Double-blinded, Randomised Clinical Trial |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02553005 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Susana Seca, MSc |
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Address:
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Telephone:
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+351914265319 |
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Email:
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susana.seca@hotmail.com |
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Affiliation:
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Name:
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Susana Seca, MSc |
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Address:
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Telephone:
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+351914265319 |
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Email:
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susana.seca@hotmail.com |
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Affiliation:
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Name:
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Susana Seca, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Coimbra |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Compliance inform consent
- Patients with RA
- Fulfill The ACR criteria of RA
- Impairment of the hand strength with or without pain in the hands during the grip
procedure
- Chronic pain: either persistent or intermittent over a minimum period of three months
prior to recruitment
- Current pain: greater than 30/ 100 mm on a pain visual analogue scale (VAS) within
the last 24 hours despite medication
- Patients on stable dose treatment for at least 3 weeks
Exclusion Criteria:
- Under the age of 18 years
- Previously had acupuncture
- Localized skin infections
- Severe chronic or uncontrolled co-morbid disease
- The wish to get a pension.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acupuncture
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Intervention(s)
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Procedure: Acupuncture
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Primary Outcome(s)
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gene expression profiles (Assessment by microarray)
[Time Frame: up to 19 months]
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Quality of life (Assessment by SF-36 scale)
[Time Frame: up to 19 months]
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Secondary Outcome(s)
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hand strength (Assessment by dynamometry)
[Time Frame: up to 19 months]
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hand pain (Assessment by algometry)
[Time Frame: up to 19 months]
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Interleucines levels in blood
[Time Frame: up to 12 months]
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Cortisol levels in blood
[Time Frame: up to 12 months]
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Secondary ID(s)
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University of Coimbra
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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