Neck Pain Clinical Trial
Official title:
Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
The purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.
Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe
and inexpensive treatment modality in complementary medicine and are used mainly in
musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their
efficacy.
The study is designed as a double blind sham controlled randomized trial to evaluate whether
patients with acute non specific neck pain get pain free sooner, if treated with
subcutaneous carbon dioxide insufflations compared to sham ultrasound.Since acute non
specific neck pain is often self limiting, speed of recovery rather than outcome at fixed
points in time is evaluated.
Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations
or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order,
thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck
muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.
Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention
to treat. Differences in time curves are tested using the logrank test. Time curves are
graphically displayed by a 1 minus survival Kaplan-Meier plot.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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