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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
  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

Resource links provided by NLM:


Further study details as provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:

Primary Outcome Measures:
  • time to neck pain relief

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325312

Locations
Germany
Praxis für Allgemeinmedizin Thomas Heißner
Lohmen, Sachsen, Germany, 01847
Sponsors and Collaborators
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Investigators
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014