Intermittent intravenous adenosine with prolonged pain in the back of the neck with allodynia/dysaesthesia.

• Conditions: Prolonged pain in the neck caused by a whiplash trauma or another muscle injury.

• Registration Number: EUCTR2004-004738-15-SE
• Lead Sponsor: Karolinska University Hospital, Huddinge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

a) Patients with verified pain in the neck, mainly in soft tissue, where other pharmacotherapy is not enough, due to insufficient effect or side effects. The patients should be diagnosed and have a regular contact with a physiotherapeut specialized in pain. The pain must have a duration of at least six months.

b) The patients should be adenosine responders, i.e. have reacted favourably with decreased pain and subjectively improved function at a minimum of one occasion with open intravenous adenosine treatment, with a qualitative bed status before and after treatment.

c) Age 18-80 years, inclusive.

d) Signed informed consent for participation in the study, including data handling and information about PUL (Personuppgiftslagen).

e) The patients are allowed to continue ongoing pharmacotherapy with a stable dosage, but are not allowed to start treatment with a new pain-relieving medicine or change such a dosage during the study period.

f) Pain at rest >=30 on a VAS scale 0 - 100.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) Participation in another clinical trial within the last month before inclusion or during the study period.

b) Another severe pain which interferes with the patient´s ability to separate and estimate the neck pain, which is intended to be studied according to the investigator´s assessment.

c) Progressive malign disease.

d) Other conditions which will make participation in the study more difficult, e.g. drug abuse and problems to communicate, according to judgement of the investigator.

e) AV-block II and III without pacemaker treatment.

f) Ongoing treatment with dipyridamol (Persantin).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified