Condition category
Musculoskeletal Diseases
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.J. Sigtermans

ORCID ID

Contact details

Leiden University Medical Center
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262301
m.j.sigtermans@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR507; LUMC P05.100; Min. of Econ. Aff., BSIK03016

Study information

Scientific title

Acronym

Study hypothesis

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

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Complex regional pain syndrome type 1 (CRPS I)

Intervention

Subjects are assigned to receive either intravenous (S+)-ketamine or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain reduction measured by numerical rating scale (0 no pain, 10 worst imaginable pain).

Secondary outcome measures

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

Overall trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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)

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Ministry of Economic Affairs (Netherlands)

Alternative name(s)

Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19604642

Publication citations

  1. Results

    Sigtermans MJ, van Hilten JJ, Bauer MC, Arbous MS, Marinus J, Sarton EY, Dahan A, Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1., Pain, 2009, 145, 3, 304-311, doi: 10.1016/j.pain.2009.06.023.

Additional files

Editorial Notes