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Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00325312
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : May 15, 2006
Sponsor:
Information provided by:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Tracking Information
First Submitted Date  ICMJE May 11, 2006
First Posted Date  ICMJE May 12, 2006
Last Update Posted Date May 15, 2006
Study Start Date  ICMJE January 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2006)
time to neck pain relief
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2006)
  • time to a 50% reduction in pain intensity
  • affective pain
  • sensory pain
  • pain intensity
  • treatment failure
  • recurrence of neck pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
Official Title  ICMJE Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE Drug: carbon dioxide, subcutaneous application
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 11, 2006)
114
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325312
Other Study ID Numbers  ICMJE SCI-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Brockow, MD FBK Bad Elster
PRS Account Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Verification Date May 2006

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