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 |
| Secondary identifying numbers | NTR507; LUMC P05.100; Min. of Econ. Aff., BSIK03016 |
- 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
Scientific
Leiden University Medical Center
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262301 |
|---|---|
| m.j.sigtermans@lumc.nl |
Study information
| Study design | Randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/12/2005 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/027bh9e22 |
|---|
Funders
Funder type
Government
Ministry of Economic Affairs (Netherlands)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
