| Methods | RCT Number analysed/randomised: 3036/3766 Intention‐to‐treat: calculated Power analysis: calculated Funding source: NR | |
| Participants | Chronic neck pain Participant recruitment: Participants with neck pain asked a participating physician for acupuncture, or physician considered acupuncture to be adequate treatment |
|
| Interventions | INDEX TREATMENT Immediate acupuncture treatment plus additional conventional treatment as needed Participants could be treated individually, and numbers of needles and acupuncture points used were chosen at the discretion of physicians. Only needle acupuncture (with disposable 1‐time needles) and manual stimulation were allowed, whereas other forms of acupuncture treatment were not allowed COMPARISON TREATMENT Conventional treatment; delayed acupuncture treatment 3 months after study onset Control group was not allowed to use any kind of acupuncture during first 3 months CO‐INTERVENTION Comparable between index and control groups. Participants were free to use conventional routine medical care as offered by German social health insurance funds Treatment schedule: Each participant in the randomised acupuncture group received up to 15 acupuncture sessions during first 3 months and no acupuncture sessions between 3 and 6 months Duration of treatment: 3 months Duration of follow‐up: 3 months after treatment |
|
| Outcomes | HEALTH AND WELL‐BEING Neck and pain disability assessed by validated neck and pain disability scale developed by Wheeler Baseline mean: 55.0 immediate acupuncture (randomised), 56.0 (immediate acupuncture non‐randomised), 53.9 delayed acupuncture % reduction in neck pain and disability Time 1 (3 months): 28.9 immediate acupuncture (randomised), 31.7 immediate acupuncture (non‐randomised), 5.8 delayed acupuncture Time 2 (6 months): 28.0 immediate acupuncture (randomised), 30.6 immediate acupuncture (non‐randomised), 25.1 delayed acupuncture Reported results: significant at time 1 SMD ‐35.53 (95% CI random ‐36.37 to ‐34.69) at 3 month follow‐up SMD 4.14 (95% CI random 4.02 to 4.26) at 6 month follow‐up SF‐36 PHYSICAL COMPONENT SCORE Baseline mean: 37.6 immediate acupuncture (randomised), 36.7 immediate acupuncture (non‐randomised), 38.1 delayed acupuncture Time 1 (3 months): 5.8 immediate acupuncture (randomised), 6.8 immediate acupuncture (non‐randomised), 4.7 delayed acupuncture Time 2 (6 months): 5.6 immediate acupuncture (randomised), 6.8 immediate acupuncture (non‐randomised), 0.7 delayed acupuncture SMD 22.99 (95% CI random 22.45 to 23.54) at 3 month follow‐up SMD 3.00 (95% CI random 2.90 to 3.10) at 6 month follow‐up SF‐36 MENTAL COMPONENT SCORE Baseline mean: 43.1 immediate acupuncture (randomised), 42.8 immediate acupuncture (non‐randomised), 43.8 delayed acupuncture Time 1 (3 months): 4.2 immediate acupuncture (randomised), 4.7 immediate acupuncture (non‐randomised), 3.1 delayed acupuncture Time 2 (6 months): 4.0 immediate acupuncture (randomised), 4.8 immediate acupuncture (non‐randomised), 3.1 delayed acupuncture SMD 12.80 (95% CI random 12.49 to 13.11) at 3 month follow‐up SMD 3.00 (95% CI random 2.90 to 3.10) at 6 month follow‐up Reasons for drop‐out: 315 participants could not be included in the ITT analysis because the study office did not receive the consent form Adverse effects: 8.9% of cases (n = 1005); 1216 side effects were reported: 57% minor local bleeding or hematoma, 10% pain (e.g. needling pain), 4% vegetative symptoms, 29% other Costs of care: acupuncture treatment associated with higher costs (€925.53 ± 1551.06 vs €648.06 ± 1459.13); however according to assumed threshold values beyond 3 month follow‐up, acupuncture appears cost‐effective. Also, over‐the‐counter medications were not included in the cost of routine care |
|
| Notes | ‐‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised using a central telephone randomisation procedure |
| Allocation concealment (selection bias) | Low risk | Study office included participants into the study |
| Blinding (performance bias and detection bias) All outcomes ‐ patient? | High risk | Not possible |
| Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | Not possible |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? | High risk | Participant as outcome assessor not blinded |
| Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? | High risk | Drop‐outs not adequately described |
| Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? | Unclear risk | Unclear whether ITT was done correctly |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Similarity of baseline characteristics | Low risk | Reported to be similar |
| Co‐interventions avoided or similar? | Unclear risk | Not reported |
| Compliance acceptable? | Low risk | Most participants (77.3%) received 5 to 10 sessions, whereas 17.7% received more than 10 sessions and 5% fewer than 5 sessions |
| Similar timing of outcome assessment? | Low risk | Assessed at 3 and 6 months |
| Fatal Flaw | Low risk | Acceptable |
Abbreviations: BL = bladder CI = confidence interval cm = centimetre dn = dry needling EAP = electroacupuncture
g = gauge GB = gallbladderITT = intention‐to‐treat LI = large intestine LLLT0 = placebo intestine mg = milligram mm = millimetreMPS = myofascial neck pain syndrome MTrP = muscles treated not described NA = not applicable NDI = Neck Disability Index NLA = non‐local needle electroacupuncture NPQ = Northwick Park Pain Questionnaire NR = not reported NSAID = non‐steroidal anti‐inflammatory drug NTPA = non‐trigger point acupuncture OD = daily PPT = pain pressure threshold RA = remote acupuncture RCT = randomised controlled trial SA = standard acupuncture SD = standard deviation SF‐36 = Short Form‐36 SH = sham treatment SI = small intestine SMD = standardised mean difference TCM = Traditional Chinese Medicine TE = triple energiser TENS = transcutaneous electrical nerve stimulation TNS = transcutaneous nerve stimulation TPA = trigger point acupuncture TrP = trigger point acupuncture VAS = visual analogue scale WAD = whiplash‐associated disorder