Condition category
Musculoskeletal Diseases
Date applied
31/01/2008
Date assigned
13/02/2008
Last edited
28/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liliana Lourenço Jorge

ORCID ID

Contact details

Rua Guaramembé
589
Sao Paulo
01308-050
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project number at Institute of Orthopaedics and Traumatology: 371

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy of acupuncture for spinal pain relief in patients diagnosed with Ankylosing Spondylitis (AS).

Ethics approval

Ethics Committee of the University Hospital, University of Sao Paulo, School of Medicine, approved on 8 October 2003 (CAPPESQ number: 769-03)

Study design

Prospective, double-blind, randomised placebo-controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pain relief in patients diagnosed with ankylosing spondylitis

Intervention

Randomization was performed using colored balls. Patients rated their pain intensity using VAS, disease activity, and function level at baseline.

Patients were randomly allocated to one of two treatment groups:

Group A: Classical acupuncture. Participants received classical acupuncture treatment associated with the use of NSAIDs and analgesics. Disposable, sterilized, stainless steel 0.25 mm x 40 mm length needles were employed. 10 acupuncture sessions, twice weekly, 20 minutes per session. Each patient was treated in a separate room.

Group B: Sham acupuncture. Participants received NSAIDs and analgesics together with non-invasive sham electro acupuncture, which was performed using inactive surface electrodes with audiovisual biofeedback reinforcement, touching patient's skin for seven seconds. 10 acupuncture sessions, twice weekly, 20 minutes per session. Each patient was treated in a separate room.

Acupuncture points employed in both groups: GV20b, SI3b, BL62b, GB34b and Ex-B2b

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following were assessed before and immediately after the interventions:
1. Patient's assessment of spinal pain (0-10 cm VAS).
2. Patient's global assessment of disease-activity and function (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Bath Ankylosing Spondylitis Functional Index [BASFI]). The BASDAI measures the severity of fatigue, spinal and peripheral joint pain, localized tenderness, and morning stiffness, assessed on a 10 cm VAS. The BASFI measures the functional status of AS patients, and is also assessed on a 10 cm VAS.
3. Acute-phase reactants (C-Reactive Protein, Erythrocyte Sedimentation Rate [ESR], Immunoglobulin A [IgA])
4. Number of analgesic pills per week

Secondary outcome measures

Subjective assessment of pain, performed before and immediately after the interventions, using a 7-point Likert scale, where 1 = much worse, 2 = moderately worse, 3 = slightly worse, 4 = no effect, 5 = small improvement, 6 = moderate improvement, 7 = great improvement.

Overall trial start date

01/05/2003

Overall trial end date

15/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age range between 20 and 60 years
2. Painful complaints in the axial line
3. Patients who have not received any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or analgesics for three months prior to the inclusion into this trial
4. Those who are referred to the Rheumatology Service, University of São Paulo, University Hospital, School of Medicine with diagnosis of ankylosing spondylitis according to the New York 15 and European 16 criteria for spondyloarthropathies
5. A mean baseline Visual Analogue Scale (VAS) score >= 4 for pain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Severe psychiatric disease
2. Sensory or motor neurological deficits
3. Fibromyalgia
4. Previous treatment with acupuncture
5. Unable to visit the hospital for treatment

Recruitment start date

01/05/2003

Recruitment end date

15/01/2004

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Guaramembé, 589
Sao Paulo
01308-050
Brazil

Sponsor information

Organisation

University of São Paulo (Brazil)

Sponsor details

São Carlos
Ribeirão Preto
Sao Paulo
-
Brazil

Sponsor type

University/education

Website

http://www2.usp.br

Funders

Funder type

University/education

Funder name

University of São Paulo, University Hospital (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes