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

Tracking Information

First Received Date ^ICMJE

May 11, 2006

Last Updated Date

May 12, 2006

Start Date ^ICMJE

January 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

time to neck pain relief

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00325312 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Neck Pain

Intervention ^ICMJE

Drug: carbon dioxide, subcutaneous application

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

114

Completion Date

March 2003

Primary Completion Date

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00325312

Responsible Party

Study ID Numbers ^ICMJE

SCI-2

Study Sponsor ^ICMJE

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas Brockow, MD

FBK Bad Elster

Information Provided By

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