Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain - Tabular View

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Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

This study has been completed.

Study NCT00325312. Last updated on May 12, 2006. Information provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

Official Title ^†

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

time to neck pain relief

Secondary Outcome Measure ^†

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

Condition ^†

Neck Pain

Intervention ^†

Drug: carbon dioxide, subcutaneous application

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

114

Start Date ^†

January 2001

Completion Date

March 2003

Eligibility 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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00325312

Organization ID

SCI-2

Secondary IDs ^††

Study Sponsor ^†

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Collaborators ^††

Investigators ^†

Principal Investigator:

Thomas Brockow, MD

FBK Bad Elster

Information Provided By

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Verification Date

May 2006

First Received Date ^†

May 11, 2006

Last Updated Date

May 12, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.