NCT02553005

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

September 12, 2015

Last Update Submit

September 25, 2015

Conditions

Acupuncture

Keywords

AcupunctureRheumatoid ArthritisQuality of lifeHand Strength

Outcome Measures

Primary Outcomes (2)

  • gene expression profiles (Assessment by microarray)

    Assessment by microarray

    up to 19 months

  • Quality of life (Assessment by SF-36 scale)

    Assessment by SF-36 scale

    up to 19 months

Secondary Outcomes (4)

  • Cortisol levels in blood

    up to 12 months

  • Interleucines levels in blood

    up to 12 months

  • hand pain (Assessment by algometry)

    up to 19 months

  • hand strength (Assessment by dynamometry)

    up to 19 months

Study Arms (3)

sham acupuncture

SHAM COMPARATOR

False acupuncture treatment using not acupuncture points

Procedure: Acupuncture

verum acupuncture

EXPERIMENTAL

Real acupuncture treatment

Procedure: Acupuncture

Control

NO INTERVENTION

Interventions

AcupuncturePROCEDURE
sham acupunctureverum acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - University of Coimbra

Coimbra, Coimbra District, 3045, Portugal

RECRUITING

Related Publications (1)

  • Seca S, Kirch S, Cabrita AS, Greten HJ. Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis--A study protocol for a multicenter, double-blind, randomized clinical trial. J Integr Med. 2016 May;14(3):219-27. doi: 10.1016/S2095-4964(16)60254-6.

    PMID: 27181129DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Susana Seca, MSc

    University of Coimbra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Seca, MSc

CONTACT

+351914265319susana.seca@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2015

First Posted

September 17, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

June 1, 2017

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

PT(1)