Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice

Conditions
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Neck Pain

Intervention / Treatment
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* Drug: carbon dioxide, subcutaneous application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants must report neck pain lasting for less than 7 days participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale. participants must state local neck muscles tenderness during clinical examination at one or more locations Exclusion Criteria: neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases) whiplash injury former neck surgery pregnancy breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carbon dioxide, subcutaneous application|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to neck pain relief |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to a 50% reduction in pain intensity |  |  | 
| affective pain |  |  | 
| sensory pain |  |  | 
| pain intensity |  |  | 
| treatment failure |  |  | 
| recurrence of neck pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck Pain, Complementary Therapies, Subcutaneous Carbon Dioxide Insufflations, Acute Treatment