Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

Neck Pain Clinical Trial

Official title:

Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325312
• Other study ID #: SCI-2
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2006
• Last updated: May 12, 2006
• Start date: January 2001
• Est. completion date: March 2003

Study information

• Verified date: May 2006
• Source: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Drug:
• carbon dioxide, subcutaneous application

Locations

Country	Name	City	State
Germany	Praxis für Allgemeinmedizin Thomas Heißner	Lohmen	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to neck pain relief
Secondary	time to a 50% reduction in pain intensity
Secondary	affective pain
Secondary	sensory pain
Secondary	pain intensity
Secondary	treatment failure
Secondary	recurrence of neck pain