Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-03-31

Brief Summary

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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

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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.

Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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carbon dioxide, subcutaneous application

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas Brockow, MD

Role: PRINCIPAL_INVESTIGATOR

FBK Bad Elster

Locations

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Praxis für Allgemeinmedizin Thomas Heißner

Lohmen, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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SCI-2

Identifier Type: -

Identifier Source: org_study_id