Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325312
Status:
COMPLETED
Last Update Posted:
2006-05-15
First Post:
2006-05-11
Brief Title:
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
Sponsor:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Organization:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Study Overview
Official Title:
Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ultrasoundSince 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
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 ultrasoundSince 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None