Stener‐Victorin 2004.
Methods | Design: Parallel Blinding: No blinding Attempt to confirm patient blinding for sham control?: NA Drop‐outs/withdrawals: At the end of treatment assessment (i.e. at end of 5 weeks of treatment) there were 13/15 available in the EA group; 13/15 in the hydrotherapy group; and 8/15 in the patient education group. For the short‐term follow‐up as defined for this review (i.e. 1 month after the end of treatment or ˜9 weeks after baseline), the numbers available for analysis were not provided in the paper. However, the authors provided these data as follows: EA = 13; Water = 13; Control = 12. At the six months post‐end of treatment assessment (i.e. the long‐term follow‐up as defined for this review), there were 9/15 available in both the EA and hydrotherapy groups, and 7/15 available in the patient education group. CBRG score: [1]‐[1]‐0‐0‐0‐0‐1‐?‐0‐0‐0 Duration: 5 weeks of treatment with EA or hydrotherapy followed by an observation period of an additional six months Type of analysis reported: not explicitly stated but assumedly per protocol analysis | |
Participants | Setting: outpatient physiotherapy clinic, Molndal, Sweden Mean age (+/‐SD or Range): ˜67 Men/Women (n/n): 18/27 Recruitment method: Recruited from patients on a waiting list for total hip arthroplasty Mean pain duration (SD) years: Not reported For bilateral OA diagnosis, which hip treated/evaluated?: Not reported Diagnosis of hip OA required to be eligible? (if yes, describe how patients were verified to have OA): Yes, diagnosis was based on radiographic changes consistent with hip OA and pain related to motion and/or pain on load or rest Radiologic evidence of hip OA required to be eligible? (if yes, describe requirement): Yes, only states that radiographic changes consistent with hip OA required to be eligible Minimum duration (and extent) of hip pain required to be eligible: Not reported Hospital inpatients? (Y/N; if Y list number inpatients): No Previous hip surgery? (Y/N; if Y list number with previous knee surgery): Not reported Were people with a history of acupuncture treatment excluded? Not reported (assume no, since no sham group) Other important inclusion criteria: None Important exclusion criteria: patients with other rheumatoid diseases | |
Interventions | TEST GROUP INTERVENTION: acupuncture
N allocated to acupuncture: 15
Style of acupuncture: Chinese
Point selection: Flexible formula
Points stimulated: Electroacupuncture locally at 4 of following points: BL 54, 36, GB 29, 30, 31, and ST 31. Distal points were always the same: GB34 and BL 60 ipsilateral
Total length of treatment period (weeks): 5 weeks
Number of sessions target (mean): 10 (?mean)
Times per week: 2
Number of points used: 6
Insertion depth: 15‐35mm
Was De qi reportedly sought?: Yes
Duration (mins): 30
Method of stimulation: Electrical stimulation at all points and needles were also rotated manually 4 times during each treatment to evoke needle sensation CONTROL GROUP A (sham, if used): hydrotherapy ‐‐ consisted of warming up, mobility and strengthening and stretching exercises for area around the hip, in small groups of 1‐3, in warm water N allocated to control group A: 15 Total length of treatment period: 5 weeks Number of sessions target (mean): 10 (?mean) Times per week: 2 (If relevant) Number of points used: NA (If relevant) Insertion depth: NA Was De qi sought?: NA Duration (mins): 30 (If relevant) Method of stimulation: NA CONTROL GROUP B: Patient education about anatomy and physiology of hip, pain relief, and total hip arthroplasty. They were also given home exercise instructions. They were taught to train once per day with intensity below pain. N allocated to control group B: 15 Total length of treatment period: Not reported Number of sessions target (mean): 2 (?mean) Times per week: Not clear Duration (minutes): 120 Any co‐interventions in all groups?: All groups received the patient education co‐intervention. |
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Outcomes | The pain outcome was pain intensity using the VAS scale and the function outcome was the disease‐related handicap as assessed by the (disability rating index) DRI. Other outcomes that were not extracted were the overall assessment of patient satisfaction on the Comparative Scale (Carlsson) and the Quality of life measurement, using the ‘Everyday Life’ questionnaire (Bullinger). The outcomes were reported as medians and interquartile ranges rather than as means and SDs. | |
Notes | Randomization stated to be done using "sealed, unlabeled envelopes". In response to an e‐mail request for further information about this, the author stated that the generation of the randomization sequence was computerized, the envelopes were opaque and placed in a dark box and then selected by the trial participants, and that the process was administered by an independent person not responsible for determining the eligibility of the patients. This study reported median results rather than means, which is the primary reason that this trial did not contribute to effect size estimates. In addition, because of the high attrition rate at 6 months, a post hoc decision was made to not enter the 6 months follow‐up median data as 'Other data' in RevMan. The short‐term follow‐up median data (i.e. the data at 1 month after last treatment = 9 weeks after baseline) was also not entered as 'Other data' in RevMan because the numbers available for follow‐up were not reported at that time point. Overall conclusions of RCT author: "The main outcome of the study was that EA and hydrotherapy, both in combination with patient education, offer clear advantages for patients with hip pain caused by osteoarthritis over patient education alone, as shown by reduced pain, increased function, and increased quality of life." Source of support: This study was "supported by Research and Development Unit, Vastra Goteborg, Sweden". Assumed it's supported by government grant. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | “Participants were randomly allocated to EA in combination with patient education (n = 15) or hydrotherapy in combination with patient education (n = 15) as a control by using sealed, unlabeled envelopes.” In response to an e‐mail request for further information about this, the author stated that the generation of the randomization sequence was computerized, and that the process was administered by an independent person not responsible for determining the eligibility of the patients. |
Allocation concealment? | Low risk | “Participants were randomly allocated to EA in combination with patient education (n = 15) or hydrotherapy in combination with patient education (n = 15) as a control by using sealed, unlabeled envelopes.“ In response to an e‐mail request for further information about this, the author stated that the envelopes were opaque and placed in a dark box and then selected by the trial participants, and that the process was administered by an independent person not responsible for determining the eligibility of the patients. |
Blinding? Versus sham | High risk | EA vs. hydrotherapy and patient education, no sham control. |
Incomplete outcome data addressed? Short term | Low risk | For the short‐term follow‐up as defined for this review (i.e. 1 month after the end of treatment or ˜9 weeks after baseline), the numbers available for analysis were not provided in the paper. However, the authors provided these data as follows: EA = 13(15); Water = 13(15); Control = 12(15). At the six months post‐end of treatment assessment (i.e. the long‐term follow‐up as defined for this review), there were 9(15) available in both the EA and hydrotherapy groups, and 7(15) available in the patient education group. See Figure 1. |
Free of selective reporting? | Low risk | “The EA and hydrotherapy groups were assessed before the intervention and immediately after the last treatment. Follow‐up included 1 assessment at 1, 3 and 6 months after the last treatment. The control group was assessed at the same point of time except from the time immediately after the last treatment.” “Outcome measures were determined by a functional index, called the disability rating index (DRI), a quality‐of‐life status called the global self‐rating index (GSI), and for pain, the visual analogue scale (VAS).“ Findings reported in Table 6, 3. |
Free of other bias? | High risk | Baseline is not similar among groups. “The control group (patient education group) was assessed at the same point of time except from the time immediately after the last treatment.” Timings of assessment were not similar among groups. Patients compliance condition was not reported. No ITT analysis was applied. |