Effect of acupuncture in pain relief and functional improvement in ankylosing spondylitis: a randomized controlled trial
- Conditions
- Pain relief in patients diagnosed with ankylosing spondylitisMusculoskeletal Diseases
- Registration Number
- ISRCTN02971192
- Lead Sponsor
- niversity of São Paulo (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following were assessed before and immediately after the interventions: <br>1. Patient's assessment of spinal pain (0-10 cm VAS). <br>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.<br>3. Acute-phase reactants (C-Reactive Protein, Erythrocyte Sedimentation Rate [ESR], Immunoglobulin A [IgA]) <br>4. Number of analgesic pills per week
- Secondary Outcome Measures
Name Time Method 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.