Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
carbon dioxide, subcutaneous application
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Complementary Therapies, Subcutaneous Carbon Dioxide Insufflations, Acute Treatment
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.
Sites / Locations
- Praxis für Allgemeinmedizin Thomas Heißner
Outcomes
Primary Outcome Measures
time to neck pain relief
Secondary Outcome Measures
time to a 50% reduction in pain intensity
affective pain
sensory pain
pain intensity
treatment failure
recurrence of neck pain
Full Information
NCT ID
NCT00325312
First Posted
May 11, 2006
Last Updated
May 12, 2006
Sponsor
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
1. Study Identification
Unique Protocol Identification Number
NCT00325312
Brief Title
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
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Complementary Therapies, Subcutaneous Carbon Dioxide Insufflations, Acute Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
114 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carbon dioxide, subcutaneous application
Primary Outcome Measure Information:
Title
time to neck pain relief
Secondary Outcome Measure Information:
Title
time to a 50% reduction in pain intensity
Title
affective pain
Title
sensory pain
Title
pain intensity
Title
treatment failure
Title
recurrence of neck pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Brockow, MD
Organizational Affiliation
FBK Bad Elster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Praxis für Allgemeinmedizin Thomas Heißner
City
Lohmen
State/Province
Sachsen
ZIP/Postal Code
01847
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
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