Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

May 12, 2006 updated by: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Lohmen, Sachsen, Germany, 01847
        • Praxis für Allgemeinmedizin Thomas Heißner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
time to neck pain relief

Secondary Outcome Measures

Outcome Measure
pain intensity
time to a 50% reduction in pain intensity
affective pain
sensory pain
treatment failure
recurrence of neck pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Investigators

  • Principal Investigator: Thomas Brockow, MD, FBK Bad Elster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 15, 2006

Last Update Submitted That Met QC Criteria

May 12, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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