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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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ClinicalTrials.gov Identifier: NCT02553005
Recruitment Status : Unknown
Verified September 2015 by Susana Seca, University of Coimbra.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Susana Seca, University of Coimbra

Brief Summary:

Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, western acupuncture studies on RA show no conclusive positive result. Acupuncture is regarded as a reflex therapy, and Traditional Chinese Medicine (TCM) diagnosis was shown to be an individual neurovegetative state allowing to individually allocated acupoints. Positive results were reported using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun. The investigators are interested if acupuncture compatible with this ancient theory would be successful in improve hand function in RA patients.

The investigators therefore developed a prospective randomized control trial in a three-armed parallel group design with a standardized treatment intervention. Only patients with the TCM diagnosis of a so-called Turning Point syndrome will be allowed in the experimental phase. This may harmonize TCM diagnosis and the standardized intervention, in order to optimize potential therapeutic effects.


Condition or disease Intervention/treatment Phase
Acupuncture Procedure: Acupuncture Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: sham acupuncture
False acupuncture treatment using not acupuncture points
Procedure: Acupuncture
Experimental: verum acupuncture
Real acupuncture treatment
Procedure: Acupuncture
No Intervention: Control



Primary Outcome Measures :
  1. gene expression profiles (Assessment by microarray) [ Time Frame: up to 19 months ]
    Assessment by microarray

  2. Quality of life (Assessment by SF-36 scale) [ Time Frame: up to 19 months ]
    Assessment by SF-36 scale


Secondary Outcome Measures :
  1. Cortisol levels in blood [ Time Frame: up to 12 months ]
    Assessment by cortisol levels in blood

  2. Interleucines levels in blood [ Time Frame: up to 12 months ]
    Assessment by interleucines levels in blood

  3. hand pain (Assessment by algometry) [ Time Frame: up to 19 months ]
    Assessment by algometry

  4. hand strength (Assessment by dynamometry) [ Time Frame: up to 19 months ]
    Assessment by dynamometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02553005


Contacts
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Contact: Susana Seca, MSc +351914265319 susana.seca@hotmail.com

Locations
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Portugal
Faculty of Medicine - University of Coimbra Recruiting
Coimbra, Portugal, 3045
Contact: Susana Seca, MSc    +351914265319    susana.seca@hotmail.com   
Sponsors and Collaborators
University of Coimbra
Investigators
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Principal Investigator: Susana Seca, MSc University of Coimbra

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susana Seca, Principal Investigator, University of Coimbra
ClinicalTrials.gov Identifier: NCT02553005     History of Changes
Other Study ID Numbers: University of Coimbra
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Susana Seca, University of Coimbra:
Acupuncture
Rheumatoid Arthritis
Quality of life
Hand Strength
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases