Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neck Pain |
Drug: carbon dioxide, subcutaneous application |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice |
- 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
| Estimated Enrollment: | 114 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | March 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| Praxis für Allgemeinmedizin Thomas Heißner | |
| Lohmen, Sachsen, Germany, 01847 | |
| Principal Investigator: | Thomas Brockow, MD | FBK Bad Elster |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00325312 History of Changes |
| Other Study ID Numbers: | SCI-2 |
| Study First Received: | May 11, 2006 |
| Last Updated: | May 12, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:
|
Neck Pain Complementary Therapies Subcutaneous Carbon Dioxide Insufflations Acute Treatment |
Additional relevant MeSH terms:
|
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013