Effect of acupuncture in pain relief and functional improvement in ankylosing spondylitis: a randomized controlled trial
| ISRCTN | ISRCTN02971192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02971192 |
| Secondary identifying numbers | Project number at Institute of Orthopaedics and Traumatology: 371 |
- Submission date
- 31/01/2008
- Registration date
- 13/02/2008
- Last edited
- 28/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Liliana Lourenço Jorge
Scientific
Scientific
Rua Guaramembé, 589
Sao Paulo
01308-050
Brazil
Study information
| Study design | Prospective, double-blind, randomised placebo-controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the efficacy of acupuncture for spinal pain relief in patients diagnosed with Ankylosing Spondylitis (AS). |
| Ethics approval(s) | Ethics Committee of the University Hospital, University of Sao Paulo, School of Medicine, approved on 8 October 2003 (CAPPESQ number: 769-03) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2003 |
| Completion date | 15/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 15/01/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Guaramembé, 589
Sao Paulo
01308-050
Brazil
01308-050
Brazil
Sponsor information
University of São Paulo (Brazil)
University/education
University/education
São Carlos
Ribeirão Preto
Sao Paulo
-
Brazil
| Website | http://www2.usp.br |
|---|---|
"ROR" |
https://ror.org/036rp1748 |
Funders
Funder type
University/education
University of São Paulo, University Hospital (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
