Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

• Sponsor: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster (Other)
• Overall Status: Completed
• CT.gov ID: NCT00325312
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Duration (Months): 25.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Drug: carbon dioxide, subcutaneous application	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
• Study Start Date: Jan 1, 2001
• Study Completion Date: Mar 1, 2003

Outcome Measures

Primary Outcome Measures

1. time to neck pain relief []

Secondary Outcome Measures

1. time to a 50% reduction in pain intensity []

2. affective pain []

3. sensory pain []

4. pain intensity []

5. treatment failure []

6. recurrence of neck pain []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00325312
• Other Study ID Numbers: SCI-2
• First Posted: May 12, 2006
• Last Update Posted: May 15, 2006
• Last Verified: May 1, 2006

• Keywords provided by , ,: Neck Pain; Complementary Therapies; Subcutaneous Carbon Dioxide Insufflations; Acute Treatment
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of May 15, 2006