Treatment of Complex Regional Pain Syndrome type 1: a randomised, double-blind, placebo-controlled study with S(+)-ketamine

ISRCTN	ISRCTN38472359
DOI	https://doi.org/10.1186/ISRCTN38472359
Protocol serial number	NTR507; LUMC P05.100; Min. of Econ. Aff., BSIK03016
Sponsor	Leiden University Medical Centre (Netherlands)
Funder	Ministry of Economic Affairs (Netherlands)

Submission date: 09/01/2006
Registration date: 09/01/2006
Last edited: 18/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.J. Sigtermans
Scientific

Leiden University Medical Center
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5262301
Email	m.j.sigtermans@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	S(+)-ketamine reduces pain in patients with Complex Regional Pain Syndrome type 1 having symptoms shorter than 6 months and longer than 3 years.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Complex regional pain syndrome type 1 (CRPS I)
Intervention	Subjects are assigned to receive either intravenous (S+)-ketamine or placebo.
Intervention type	Other
Primary outcome measure(s)	Pain reduction measured by numerical rating scale (0 no pain, 10 worst imaginable pain).
Key secondary outcome measure(s)	Secondary aims of the study deal with: 1. The role of NMDA receptor activation in the autonomic and motor features of CRPS 2. To establish the endurance of ketamine on the impairments of CRPS 3. To study the pharmacokinetics and pharmacodynamics of ketamine in subanaesthetic doses 4. To establish data for future pragmatic studies on ketamine iv in patients with CRPS on the levels of disability and safety
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	Patients will be male or female adult patients with a clinical diagnosis of CRPS 1 who are referred to the pain centre outpatients' clinic of the department of Anaesthesiology at the LUMC. 1. Patients should fulfill the diagnostic criteria of the consensus report of CRPS 1: 1.1. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event 1.2. Evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain 1.3. No condition that would otherwise account for the degree of pain and dysfunction 2. Patients must report a VAS-spontaneous pain score of 5 cm or higher 3. Patient's age is between 18 and 70 years 4. Onset of symptoms must be shorter than 6 months or longer than 3 years before inclusion 5. Patients should give a written informed consent
Key exclusion criteria	1. Patients who are not able to give informed consent 2. Patients suffering from other pain syndromes, interfering with pain ratings 3. Patients suffering from other syndromes interfering with pain ratings 4. Patients suffering from a kidney and/or severe liver disease 5. Patients suffering from nerve damage in the affected area 6. Patients with an active infection 7. Patients with high intracranial pressure 8. Patients with epilepsy 9. Patients with a psychiatric illness 10. Patients with thyroid disease 11. Patients with cancer 12. Patients with cardiac disease 13. Patients with pulmonary disease 14. Patients with glaucoma 15. Patients with a history of cerebral vascular accident (CVA) 16. Patients who are a pregnant 17. Strong-opioid consumption (step one and two of the WHO pain ladder is allowed)
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No