Clinical trial NCT00325312: Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
Official title: Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: Neck Pain
Complementary Therapies
Subcutaneous Carbon Dioxide Insufflations
Acute Treatment
Lead sponsor: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Sponsor class: OTHER_GOV
First posted: 2006-05-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: time to neck pain relief
Secondary outcomes:
measure: time to a 50% reduction in pain intensity
measure: affective pain
measure: sensory pain
measure: pain intensity
measure: treatment failure
measure: recurrence of neck pain
Other outcomes:
Locations:
city: Lohmen
country: Germany
facility: Praxis für Allgemeinmedizin Thomas Heißner
state: Sachsen
Study officials:
affiliation: FBK Bad Elster
name: Thomas Brockow, MD
role: PRINCIPAL_INVESTIGATOR
References: