Project number at Institute of Orthopaedics and Traumatology: 371
To evaluate the efficacy of acupuncture for spinal pain relief in patients diagnosed with Ankylosing Spondylitis (AS).
Ethics Committee of the University Hospital, University of Sao Paulo, School of Medicine, approved on 8 October 2003 (CAPPESQ number: 769-03)
Prospective, double-blind, randomised placebo-controlled trial.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Pain relief in patients diagnosed with ankylosing spondylitis
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
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
Overall trial end date
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
Target number of participants
Participant exclusion criteria
1. Severe psychiatric disease
2. Sensory or motor neurological deficits
4. Previous treatment with acupuncture
5. Unable to visit the hospital for treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Rua Guaramembé, 589
University of São Paulo (Brazil)
University of São Paulo, University Hospital (Brazil)
Funding Body Type
Funding Body Subtype
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