Sencan 2004.
| Methods | 3 groups: aerobic exercise; paroxetine; placebo transcutaneous electrical stimulation (TENS) Length: 6 weeks; follow‐up at 26 weeks Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 60:0 Age (years (SD)): 35.4 (9.6); 32.7 (9.4); 35.6 (7.9) Inclusion: diagnosis of fibromyalgia (ACR 1990), no other pharmacological treatment, other comorbid disease Exclusion: tumoral, infectious, metabolic, cardiovascular, or endocrine disease; drug dependency Duration of illness (years (SD)): 4.7; 6.5; 5.1 |
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| Interventions |
Aerobic exercise (n = 20): aerobic exercise on stationary bicycle. Frequency: 3/wk; Duration: 40 minutes; not specified; Intensity: not specified; Mode: bicycle ergometer Paroxetine (n = 20): undertaken 20 mg/d paroxetine. Frequency: 1/d, home exercise for 6 months' follow‐up (followed by telephone calls at 2 and 4 months); Duration: not specified; Intensity: not specified Placebo TENS (n = 20): given placebo TENS. Frequency: 3/wk; Duration: 20 minutes; Intensity: not specified; Mode: electrodes applied on the 2 most painful tender points (no current) *For this review: All interventions were considered |
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| Outcomes | Pain intensity (VAS) Other: tenderness (pressure algometry), depression (Beck Depression Inventory) Measurements taken at 0, 6, and 26 weeks |
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| Adherence to exercise protocols | Monitoring methods: not specified; adherence criteria: not specified; adherence: unknown | |
| Congruence with ACSM guidelines for aerobic training | Not enough information to judge | |
| Notes | Country: Turkey Language: English Study author contacted: no Funding source/declaration of interest: none stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information on the method used to generate the allocation sequence to permit judgment of risk |
| Allocation concealment (selection bias) | Unclear risk | No description of the method used for allocation concealment to permit judgment of risk |
| Blinding of self reported outcome assessment (detection bias) All outcomes | Unclear risk | Self‐report instruments: pain intensity (VAS). Although this study includes a placebo control, it was not specified whether participants were aware of the assigned intervention |
| Blinding of objective outcome assessment (detection bias) All outcomes | Low risk | Not applicable: Objective outcomes were not measured |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information on blinding of participants and personnel to permit judgment of risk |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data at post‐test |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available but it is clear that the published report includes all expected outcomes |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |