Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2008
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 CONDITION: Pain relief in patients diagnosed with ankylosing spondylitis ; Musculoskeletal Diseases ; Pain relief in patients diagnosed with ankylosing spondylitis PRIMARY OUTCOME: 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: 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. 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
Epistemonikos ID: e17283cb8668cdfc264085212df9dac4810425e1
First added on: Aug 21, 2024