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Completed

NCT Number: NCT00325312

Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Praxis für Allgemeinmedizin Thomas Heißner

Lohmen, Saxony, 01847, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carbon dioxide, subcutaneous application

Drug

Primary outcomes

  1. time to neck pain relief

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Other Gov

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
May 12, 2006
Registry last updated
May 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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