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

Sponsor:	Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Information provided by:	Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
ClinicalTrials.gov Identifier:	NCT00325312

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Neck Injuries and Disorders

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

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

Locations

Germany, Sachsen
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

Study ID Numbers:	SCI-2
Study First Received:	May 11, 2006
Last Updated:	May 12, 2006
ClinicalTrials.gov Identifier:	NCT00325312 History of Changes
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:

Signs and Symptoms
Nervous System Diseases
Neck Pain
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on November 30, 2009