MASKING DRY-NEEDLING INTERVENTION AND PLACEBO-EFFECT: RESULTS OF A SINGLE-INTERVENTION, DOUBLE-BLIND RCT STUDY IN PATIENTS WITH NON-SPECIFIC NECK PAIN

Gallego-Sendarrubias G1, Voogt L2
1Camilo José Cela, Physiotherapy, Madrid, Spain, 2Rotterdam University, Physiotherapy, Rotterdam, Netherlands

Background: Dry-needling is a widely-used treatment technique in patients with non-specific neck pain. Current evidence shows some positive results in trials concerning dry-needling although methodological flaws are often mentioned. One of the challenges of conducting a sound clinical trial about the effectiveness of dry-needling is finding a good placebo intervention.

Purpose: The purpose of this study is to further current insights into the short-term clinical effect of dry-needling in patients with non-specific neck pain. Objectives of this study are twofold and aim 1) to clarify masking-success of sham-needling, and 2) to determine both direct and one-week follow-up effects of a single intervention on pain intensity and local pressure pain thresholds (PPT´s).

Methods: We conducted a double-blind RCT involving 44 patients with non-specific neck pain. Patients were randomly allocated in either an intervention- or placebo-group and received one dry-needling/sham intervention on an active triggerpoint in the m. trapezius. Pre-, post and follow-up measures involved: 1) mean pain at rest, 2) mean pain during active rotation of the cervical spine and 3) PPT. Appropriate descriptive statistics were used to describe study sample and masking success. Non-parametric tests were used to determine within- and between-group differences.

Results: Intervention- and placebo-group were comparable at baseline. Eighty per cent of patients receiving a sham-needling intervention actually thought they had received a real dry-needling intervention, and 82 per cent thought that the needle actually passed the skin.
Within-group analyses revealed significant changes at one-week follow-up on pain intensity (rest) (intervention group: mean difference 60.22 (SD: 15.54) - 30.83 (SD: 15.98), p= .000, placebo-group: (Wilcoxon) mean difference 52.46 (SD: 14.37) - 59.56 (SD: 13.15), p= .007. Only in the intervention group a direct treatment effect was found (intervention group: (Wilcoxon) mean difference 60.22 (15.54) - 37.72(15.75), p= .000, placebo-group: (Wilcoxon) mean difference 52.46 (14.37) - 52.12 (14.47), p= .647. Between-group differences show statistical significant differences follow-up (pain intensity): (Mann-Whitney U test) 30.83 (15.97)- 59.53 (13.15), p=.000.
Differences within and between groups are statistically significant but failed to reach clinical significance levels.

Conclusion(s): Results of this study are in favour of dry-needling intervention. Patients in the intervention group show statistical significant changes on pain intensity and PPT compared with baseline and follow-up measures and compared with patients in the sham-needling group. Sham-needle intervention successfully masked real dry-needling intervention in eighty per cent of the patients.
A single-session of dry needling does not cause clinical significant changes on pain intensity. In future trials multi-session interventions should be used to determine the effect of dry-needling in patients with non-specific neck pain.

Implications: Main objective of the study was to determine masking success of sham-needling in patients with non-specific neck pain. Eighty per cent success rate is considered 'good' and allows for the use of this technique in future trials.

Keywords: Dry needling, Placebo, RCT

Funding acknowledgements: none

Topic: Musculoskeletal: spine

Ethics approval required: Yes
Institution: La paz Hospital
Ethics committee: HULP
Ethics number: 5006


All authors, affiliations and abstracts have been published as submitted.

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