Acupuncture for acute non-specific low back pain: A pilot randomised non-penetrating sham controlled trial

Kennedy, S.; Baxter, G. David; Kerr, Daniel; Bradbury, Ian; Park, J; McDonough, Suzanne

doi:10.1016/j.ctim.2007.03.001

Cited by 57 publications

(90 citation statements)

References 24 publications

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“…These approaches included shallow needling, 10 use of inactivated lasers, 11 transcutaneous electrical nerve stimulation, 4 placebo needles, 9 12 13 use of adjuvant 6 and random needling of points not related to acupuncture meridians 14 (table 1). We decided to follow other authors' suggestions 6 25 to avoid techniques, such as placebo needling, that deviate substantially from usual acupuncture practice.…”

Section: Sham Acupuncture Proceduresmentioning

confidence: 99%

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Validation of a Sham Acupuncture Procedure in a Randomised, Controlled Clinical Trial of Chronic Pelvic Pain Treatment

Lee¹,

Liong²,

Yuen³

et al. 2011

Acupunct Med

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Background Acupuncture is an attractive treatment option for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that has proved refractory to conventional medical treatments. Unfortunately, it is diffi cult to determine the benefi t of acupuncture because few studies have employed controls or had physiological outcome measures. Objective To determine the feasibility of a sham, or minimally invasive, acupuncture as a control for studies evaluating the effi cacy of acupuncture treatment for chronic pelvic pain. Methods Participants were recruited from a double-blind randomised trial comparing acupuncture with a sham procedure for patients with CP/CPPS. Acupuncture or sham procedures were performed over a 10-week period. Sham acupuncture involved placement of short needles at sites 0.5 cm away from true acupuncture points (CV1, CV4, SP6 and SP9). Participants were asked to determine their procedure allocation at the end of treatment. A total of 35 participants also agreed to have blood analyses for cortisol, β-endorphin and leucine-enkephalin. Results Thirty-fi ve (78%) of the 45 participants randomised to the sham treatment thought they had received acupuncture compared with 27 (61%) of the 44 participants randomised to acupuncture (p=0.11). Biochemical data showed no differences between the groups immediately after treatment. Thirty-two (73%) of 44 acupuncture participants met the predefi ned clinical response criterion compared with 21 (47%) of 45 sham acupuncture participants (p=0.017, relative risk 1.81, 95% CI 1.3 to 3.1). At the end of the study, β-endorphin and leucine-enkephalin levels were both higher in the acupuncture group (p<0.01). Conclusions Minimally penetrating acupuncture was found to be a valid sham control and may prove useful for evaluating the effi cacy of acupuncture for other conditions. (ClinicalTrials.gov number, NCT00260637)

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Section: Sham Acupuncture Proceduresmentioning

confidence: 99%

“…2 7 8 Several acupuncture trials have employed varied control arms. [9][10][11][12][13] Most used forms of sham acupuncture as the control treatment. Sham acupuncture usually involves needle placement.…”

Section: Introductionmentioning

confidence: 99%

Validation of a Sham Acupuncture Procedure in a Randomised, Controlled Clinical Trial of Chronic Pelvic Pain Treatment

Lee¹,

Liong²,

Yuen³

et al. 2011

Acupunct Med

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“…2 Randomized controlled trials examining the effects of acupuncture have started to use these sham devices and needles. [3][4][5] Studies examining the blinding effectiveness of the sham devices usually investigate similarities between the sensory intensities elicited by the sham and real needles that are felt by the participants. 1 If the sensory intensities to both needle types are not statistically different from each other, then it is indirectly inferred that the sham device is capable of blinding the participant.…”

mentioning

confidence: 99%

Discrimination of Real and Sham Acupuncture Needles Using the Park Sham Device: A Preliminary Study

Tan

Christie²,

St-Georges

et al. 2009

Archives of Physical Medicine and Rehabilitation

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This article appeared in a journal published by Elsevier. The attached copy is furnished to the author for internal non-commercial research and education use, including for instruction at the authors institution and sharing with colleagues.Other uses, including reproduction and distribution, or selling or licensing copies, or posting to personal, institutional or third party websites are prohibited. Objective: To evaluate the blinding effectiveness of the Park sham acupuncture device using participants' ability to discriminate between the real and sham acupuncture needles.Design: The design was a yes-no experiment. Judgments were made on whether the real or sham acupuncture needle was administered.Setting: University laboratory. Participants: Healthy, acupuncture-naive university students and staff (Nϭ20; median age, 22y; range, 18 -48y) recruited through convenience sampling.Interventions: Participants made yes-no judgments on whether the real or sham needle was administered to 8 acupoints (4 traditional and 4 nontraditional) along the Pericardium meridian (Pericardium 3 to Pericardium 6) on the dominant forearm.Main Outcome Measures: The accuracy index, d=, of participants' ability to discriminate between the real and sham needles (discriminability) was computed for the traditional alone, the nontraditional alone, and a combination of both types of acupoints.Results: The participants' d= between the real and sham needles was not statistically significant from d= equal to 0 for the combined traditional and nontraditional acupoints comparison and the nontraditional acupoints alone comparison (combined, t 19 ϭ1.20, Pϭ.25; nontraditional, t 19 ϭ.16, Pϭ.87). However, the participants' d= was statistically significant from d= equal to 0 for the traditional acupoints comparison (t 19 ϭ2.096, Pϭ.049).Conclusions: The Park sham acupuncture device appears to be effective in blinding participants to real acupuncture intervention when it is applied to the nontraditional acupoints and when traditional and nontraditional acupoints are combined on the forearm along the pericardium meridian. However, the sham device does not appear to blind participants effectively when traditional acupoints alone are used for the same context.

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“…1 2 Randomised controlled trials examining the effects of acupuncture have started to use these sham devices and needles. [3][4][5] Credibility studies had generally found that the participantblinding effectiveness of these sham devices were fair or good. [6][7][8] Studies examining the blinding effectiveness of the sham devices usually use only one or a small number of acupoints.…”

Section: Introductionmentioning

confidence: 99%

Discrimination Accuracy between Real and Sham Needles using the Park Sham Device in the Upper and Lower Limbs

2011

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Objective To evaluate the blinding effectiveness of the Park sham acupuncture device using participants' ability to discriminate between the real and sham acupuncture needles in the (1) upper limb (TE points) compared with pure guessing and (2) lower limb (BL points) compared with pure guessing. Methods 20 healthy acupuncture-naïve university students and staff were recruited through convenience sampling. Participants made Yes-No judgements on whether the real or sham needle was administered to four TE acupoints on the dominant upper limb, and four acupoints along the BL meridian on the dominant lower limb. The proportion of correct judgements, P(C), for each participant was calculated to indicate the discrimination accuracy of participants in distinguishing between the real and sham needles. Separate P(C) were computed for the upper limb acupoints and lower limb acupoints. The data were also pooled to calculate a P(C) for a combination of both body regions. Results The participants' discrimination accuracy between the real and sham needles was not statistically signifi cant from P(C)=0.5 (chance level) for the lower limb alone and combined body regions' acupoint comparisons (lower limb: t 19 =0.00, unadjusted p=1.00; combined: t 19 =1.75, unadjusted p=0.10). However, the participants' discrimination accuracy was statistically signifi cant from P(C)=0.5 for the upper limb acupoints alone comparison (t 19 =2.36, unadjusted p=0.03). Conclusions This study showed that the Park sham device is more likely to blind participants in differentiating between the real and sham needles in the lower limb (BL meridian) acupoints than in the upper limb (TE meridian). However, the participants' ability to differentiate between the needle types for the upper limb acupoints was signifi cantly different from chance levels.

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Acupuncture for acute non-specific low back pain: A pilot randomised non-penetrating sham controlled trial

Cited by 57 publications

References 24 publications

Validation of a Sham Acupuncture Procedure in a Randomised, Controlled Clinical Trial of Chronic Pelvic Pain Treatment

Validation of a Sham Acupuncture Procedure in a Randomised, Controlled Clinical Trial of Chronic Pelvic Pain Treatment

Discrimination of Real and Sham Acupuncture Needles Using the Park Sham Device: A Preliminary Study

Discrimination Accuracy between Real and Sham Needles using the Park Sham Device in the Upper and Lower Limbs

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