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Subcutaneous CO2 Insufflations for Acute Neck Pain

NCT00325312Phase 2

Key facts

Status: Completed
Start: Jan 2001
Countries: 1
Sponsor: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Modality: Inhalation Devices

Drugs: Carbon dioxide
Conditions: Cervicalgia

Overview

Phase 2, randomised, double-blind trial of Carbon dioxide in Cervicalgia (2 arms), sponsored by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster. Primary endpoint: Time to neck pain relief. Started Jan 2001; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Carbon Dioxide Insufflations
Subcutaneous carbon dioxide insufflations (25 ml per tender point), max 9 sessions.
Sham Ultrasound
Sham ultrasound application, max 9 sessions.

Who it enrols

Participants must have acute non-specific neck pain lasting less than 7 days with a pain intensity of at least 40 mm on a 100 mm VAS and local tenderness. Exclusions include specific etiologies (e.g., radiculopathy, infection), whiplash, prior neck surgery, pregnancy, and breastfeeding.

Endpoints

Primary

Time to neck pain relief

Secondary

Time to a 50% reduction in pain intensity
Affective pain
Sensory pain
Pain intensity
Treatment failure
Recurrence of neck pain

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