Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
|ClinicalTrials.gov Identifier: NCT00325312|
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : May 15, 2006
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Drug: carbon dioxide, subcutaneous application||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice|
|Study Start Date :||January 2001|
|Estimated Study Completion Date :||March 2003|
- time to neck pain relief
- time to a 50% reduction in pain intensity
- affective pain
- sensory pain
- pain intensity
- treatment failure
- recurrence of neck pain
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325312
|Praxis für Allgemeinmedizin Thomas Heißner|
|Lohmen, Sachsen, Germany, 01847|
|Principal Investigator:||Thomas Brockow, MD||FBK Bad Elster|