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Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

This study has been completed.
Sponsor:
Information provided by:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
ClinicalTrials.gov Identifier:
NCT00325312
First received: May 11, 2006
Last updated: May 12, 2006
Last verified: May 2006
History of Changes

May 11, 2006
May 12, 2006
January 2001
Not Provided
time to neck pain relief
Same as current
Complete list of historical versions of study NCT00325312 on ClinicalTrials.gov Archive Site
  • time to a 50% reduction in pain intensity
  • affective pain
  • sensory pain
  • pain intensity
  • treatment failure
  • recurrence of neck pain
Same as current
Not Provided
Not Provided
 
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Neck Pain
Drug: carbon dioxide, subcutaneous application
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
March 2003
Not Provided

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00325312
SCI-2
Not Provided
Not Provided
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Not Provided
Principal Investigator: Thomas Brockow, MD FBK Bad Elster
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP