NCT00325312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
Last Updated

May 15, 2006

Status Verified

May 1, 2006

First QC Date

May 11, 2006

Last Update Submit

May 12, 2006

Conditions

Neck Pain

Keywords

Neck PainComplementary TherapiesSubcutaneous Carbon Dioxide InsufflationsAcute Treatment

Outcome Measures

Primary Outcomes (1)

  • time to neck pain relief

Secondary Outcomes (6)

  • time to a 50% reduction in pain intensity

  • affective pain

  • sensory pain

  • pain intensity

  • treatment failure

  • +1 more secondary outcomes

Interventions

carbon dioxide, subcutaneous applicationDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases)
  • whiplash injury
  • former neck surgery
  • pregnancy
  • breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis für Allgemeinmedizin Thomas Heißner

Lohmen, Saxony, 01847, Germany

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Thomas Brockow, MD

    FBK Bad Elster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

January 1, 2001

Study Completion

March 1, 2003

Last Updated

May 15, 2006

Record last verified: 2006-05

Locations

DE(1)