Stener‐Victorin 2004

Methods	Design: parallel Blinding: no blinding Attempt to confirm participant 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 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. Duration: 5 weeks of treatment with EA or hydrotherapy followed by an observation period of an additional 6 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 years 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 participants 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. It only stated 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: participants with other rheumatoid diseases
Interventions	TEST GROUP INTERVENTION: acupuncture plus patient education N allocated to acupuncture: 15 (13 analyzed at 1 month after last treatment) 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 Times per week: 2 Number of points used: 6 Insertion depth: 15 to 35 mm 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 plus patient education (hydrotherapy consisted of warming up, mobility and strengthening, and stretching exercises for area around the hip, in small groups of 1 to 3, in warm water) N allocated to control group A: 15 (13 analyzed at 1 month after last treatment) Total length of treatment period: 5 weeks Number of sessions target (mean): 10 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: participant education alone 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 (12 analyzed at 1 month after last treatment) Total length of treatment period: not reported Number of sessions target (mean): 2 Times per week: not clear Duration (minutes): 120 Any cointerventions in all groups?: all groups received the patient education cointervention
Outcomes	The pain outcome was pain intensity using the VAS scale and the function outcome was the disease‐related handicap as assessed by the DRI (Disability Rating Index). The quality of life outcome was the GSI (Global Self‐rating Index). The outcomes were reported as medians and interquartile ranges, rather than as means and SDs. Radiographic joint changes: not reported pain: VAS; Ache during day (median (interquartile range)); Ache during night (median (interquartile range)); function: DRI (median (interquartile range)) Quality of life: GSI (median (interquartile range))
Notes	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. However, the authors provided these data as follows: EA = 13 (/15); Water = 13 (/15); Control = 12 (/15). 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 was supported by government grant.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	In response to an email request for further information about this, the author stated that the generation of the randomizations sequence was computerized, and that the process was administered by an independent person not responsible for determining the eligibility of the participants.
Allocation concealment (selection bias)	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 email 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 participants.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	High risk	EA plus patient education vs. hydrotherapy plus patient education vs. patient education alone, no sham control
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	EA plus patient education vs. hydrotherapy plus patient education vs. patient education alone, no sham control Care providers could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	EA plus patient education vs. hydrotherapy vs. patient education alone, no sham control The outcome assessments (VAS pain and DRI function) were made by the participants themselves, by completing questionnaires, because the participants knew which group they were in, they could not be blinded for outcome assessment.
Incomplete outcome data (attrition bias) 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 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 alone group. See Figure 1. No ITT analysis was applied. However, there were a relatively small number of dropouts in the three groups (i.e. 2/15, 2/15, 3/15) at the short‐term follow‐up.The degree of missing data would be unlikely to affect the estimate of the treatment effect.
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for VAS pain, DRI function and GSI quality of life scores at baseline and immediately after the last treatment, as well as 1, 3 and 6 months after the last treatment, as described in the Material and Methods section.
Other bias	High risk	1. Baseline was not similar among groups (high risk). 2. Cointervention: not reported (unclear risk) 3. Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions received by participants was reported. (unclear risk)  4. “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. (high risk)