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. 2010 Jan 20;2010(1):CD001977. doi: 10.1002/14651858.CD001977.pub2

Christensen 1992.

Methods Design: Parallel 
 Blinding: Outcomes assessor blinding for only the objective outcome measures. However, since the outcomes that were extracted were primarily assessed by the unblinded patients, we did not consider this trial to have used blinding. 
 Attempt to confirm patient blinding for sham control?: Not applicable (no sham control) 
 Drop‐outs/withdrawals: 3 in first eight weeks 
 
 CBRG score: ?‐0‐1‐0‐0‐1/0‐?‐?‐1‐1‐0 (for outcomes assessor blinded item, number preceding / is patient assessed outcome and number following / is objective outcome assessed by blinded observer) 
 Duration: 3 weeks of acupuncture followed by six weeks of follow‐up for randomized part of study 
 Type of analysis reported: Available case analysis (probably)
Participants Setting: Hospital outpatients, Denmark 
 Mean age (+/‐SD or Range): 69.2 (median) (range: 48‐75) 
 Men/Women (n/n): 9/20 
 Recruitment method: 58 patients on county waiting list for knee replacement due to osteoarthritis were invited to participate 
 Mean pain duration (SD) years: 4.3 years median (range: 6 months to 44 years) 
 For bilateral OA diagnosis, which knee treated/evaluated?: Both knees 
 Diagnosis of knee OA required to be eligible? (if yes, describe how patients were verified to have OA): All patients waiting for knee replacement due to osteoarthritis of the knee 
 Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): All knees x‐rayed and classified according to Ahlback classification 
 Minimum duration (and extent) of knee pain required to be eligible: Not reported 
 Hospital inpatients? (Y/N; if Y list number inpatients): Not reported 
 Previous knee surgery? (Y/N; if Y list number with previous knee surgery): Not reported 
 Were people with a history of acupuncture treatment excluded? No, but acupuncture treatment within past year was an exclusion criterion 
 Other important inclusion criteria: Not stated 
 Important exclusion criteria: Neurological diseases, psychiatric disorders, connective tissue disease affecting knee, patients who experienced infection of knee or changed analgesic during course of study were excluded
Interventions TEST GROUP INTERVENTION: acupuncture 
 N allocated to acupuncture: 17? 
 Style of acupuncture: Chinese 
 Point selection: Formula 
 Points stimulated: ST34, 35, 36, SP10, EX32 (Xiyan), LI4 
 Total length of treatment period (weeks): 3 
 Number of sessions target (mean): 6 (?mean) 
 Times per week: 2 
 Number of points used: 6 or 12 depending if one or both knees affected 
 Insertion depth: 10‐15 mm 
 Was De qi reportedly sought?: Yes 
 Duration (mins): 20 
 Method of stimulation: Manual stimulation of needles
CONTROL GROUP A (sham, if used): Waiting list 
 N allocated to control group A: 15? 
 Total length of treatment period: Not applicable 
 Number of sessions target (mean): Not applicable 
 Times per week: Not applicable 
 (If relevant) Number of points used: Not applicable 
 (If relevant) Insertion depth: Not applicable 
 Was De qi sought?: Not applicable 
 Duration (mins): Not applicable 
 (If relevant) Method of stimulation: Not applicable
Any co‐interventions in all groups? Analgesics
Outcomes PAIN, FUNCTION, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS
(Outcome data not included in meta‐analysis because of confusing presentation and difficulties in data interpretation.) 
 Pain: VAS pain intensity scale: Baseline, end of treatment, and 2, 3, and 4 weeks after end of treatment 
 Function: HSS knee function scale and walking distance: Baseline, end of treatment and 4 weeks after end of treatment 
 Total: WOMAC total 
 Type of outcome data reported (i.e., post treatment/change from baseline/both): (Median values, ranges, and 95% confidence limits of median difference at the post‐treatment measurement points) 
 Additional outcomes reported in the trial but not abstracted: Analgesic use 
 Adverse effects: Only reported for total group
Notes Comments: Carefully carried out, but somewhat confusing presentation of data makes study difficult to interpret, which is the reason that this trial did not contribute to effect size estimates. The patients in the waiting list group received acupuncture after 9 weeks and all results after 9 weeks were pooled for the two treated groups, and therefore, post‐9‐week results were not extracted.
Weak points: Not blinded, poor report, small sample size
Source of support: Not reported.
For this trial, the method of generating the randomization sequence was not described in the publication. According to the corresponding author "The patients were randomized at week 0 by drawing sealed opaque envelopes to group A or B." Based on the author's description, the method of randomization was adequate and the treatment allocation was concealed. Including this information from the RCT author, the Jadad scale score for this trial would be increased from 1 (based on the publication alone) to 2, and the Cochrane Back Review Group score would be increased from 4/3 (based on the publication alone) to 6/5.
Overall conclusions: This trial compared acupuncture to usual care and found a statistically significant reduction in pain, analgesic consumption, and most objective measures in the acupuncture group relative to the control.
The overall conclusions of the RCT authors, as reported in the abstract, were the following: "Comparing group A [acupuncture treatment group] to B [no‐treatment control group] there was a significant reduction in pain, analgesic consumption and in most objective measures."..."Conclusions: Acupuncture can ease the discomfort while waiting for an operation and perhaps even serve as an alternative to surgery."
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk "At the start of the short‐term study, the patients were randomly assigned to Group A or B by drawing lots."
The method of generating the randomization sequence was not described in the publication. According to the corresponding author "The patients were randomized at week 0 by drawing sealed opaque envelopes to group A or B." Based on the author's description, the method of randomization was adequate.
Allocation concealment? Low risk The method of generating the randomization sequence was not described in the publication. According to the corresponding author "The patients were randomized at week 0 by drawing sealed opaque envelopes to group A or B." Based on the author's description, the treatment allocation was concealed.
Blinding? 
 Versus sham High risk Acupuncture vs. waiting list. no sham control.
Incomplete outcome data addressed? 
 Short term Low risk "Three out of the 32 patients did not participate from week 0. They received acupuncture treatment with Group B, and they have been excluded from the rest of the results of the short‐term study, leaving 10 women and four men in Group A and 10 women and 5 men in Group B."
Free of selective reporting? Low risk WOMAC pain, function, stiffness, total and physical health scores of SF‐36 and 6 minute walk distance were reported at baseline and at 4, 8 14 and 26 week. Serious adverse events during trial were reported. Findings reported in Table 5, Table 6.
Free of other bias? High risk Co‐interventions were not reported.
Compliance acceptability condition was not reported.
ITT analysis was not applied.