Prolonged pain in the neck caused by a whiplash trauma or another muscle injury.
Conditions
Interventions
Trade Name: Adenosin Item
Product Name: Adenosin, 5 mg/ml
Pharmaceutical Form: Intravenous infusion
Other descriptive name: Adenosin, 5mg/ml
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to try the hypothesis if adenosine given intravenously and intermittently, per needed in connection with exacerbations, may decrease spontaneous pain and central sensibilization, while mobility of the neck and the patients´function are increased in patients with prolonged neck pain after a whiplash trauma. Primary variables: Decrease of spontaneous pain (VAS 0-100) Reduction of pain released by a stimulus Increased mobility in the neck (quantitative measurement) and increased function (neck pain disability index).;Secondary Objective: Secondary variables: Duration of decreased spontaneous pain. Duration of improved function. Improvement of sensor variables.;Primary end point(s): Reduction in spontaneous pain >12/100 VAS. Reduction in touch-evoked pain >50%. Neck pain, Disability Index. Improvement in neck movement range. | — |
Countries
Sweden
Outcome results
None listed