An inert and active control acupuncture needle with potential for randomised, double-blind (practitioner-patient blinding), placebo controlled trial - a validation study

INTERVENTION: Mean age: 32.1 ± 9.9 years, 31 males, 25 females Aim: To assess whether the double‐blind placebo needle is effective in a randomised clinical acupuncture trial in which multiple placebo needles are administered as treatment. Interventions: Non‐penetrating control needles which the needle tip did not reach the skin (control), non‐penetrating placebo needles which the needle tip pressed against the skin (placebo) and the penetrating (verum) needles. In this trial, each of 6 acupuncturists (mean +/‐ SD year: 12.5 ± 11.8 years) applied acupuncture treatment to 20 patients. For each treatment, the acupuncturist applied 4 needles to the subject's shoulder. After completion of treatment with 4 needles, the practitioner and subject were asked to record whether the treatment was "non‐penetrating control," "non‐penetrating placebo", "penetrating", or "unidentifiable." After the treatment, the subjects were asked on their improvement in intensity of stiff neck on a Visual Analogue Scale (VAS) ranging from ‐100 (the most intense stiff neck in the past) to 0 (no improvement) to 100 (no stiff neck). One treatment and no follow‐up. CONDITION: Healthy subjects with stiff neck ; Musculoskeletal Diseases PRIMARY OUTCOME: Numbers of correctly, incorrectly and unidentified treatments by practitioners and subjects. SECONDARY OUTCOME: Improvement of stiff neck on a VAS (0‐100) immediately after treatment. INCLUSION CRITERIA: 1. Both males and females 2. Healthy volunteers 3. Age range: 18‐70 years