Effects of continuous intravenous magnesium on features of central sensitisation in complex regional pain syndrome type one patients
| ISRCTN | ISRCTN66289967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66289967 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susan Collins
Scientific
Scientific
VU Medical Centre
Afdeling Anesthesiologie
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 0293 |
|---|---|
| s.collins@vumc.nl |
Study information
| Study design | Randomised, double blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effects of continuous intravenous magnesium on features of central sensitisation in complex regional pain syndrome type one patients |
| Study objectives | Magnesium sulphate reduces pain for more than 50% on the Box scale when compared to the baseline, and for more than two points to the placebo group. |
| Ethics approval(s) | Approval received from the Medical Ethical Review Committee of the VU University Medical Center on the 26th February 2007 (ref: 2004/153). |
| Health condition(s) or problem(s) studied | Complex Regional Pain Syndrome type 1 (CRPS I) |
| Intervention | Intervention: 70 mg/kg magnesium sulphate continuously administered in four hours via an intravenous infusion (in two 50 ml syringe) of 24 ml/hour a day for a period of five days Control: an equal amount of NaCl 0.9% solution (in two 50 ml syringe) continuously in four hours via an intravenous infusion of 24 ml/hour a day for a period of five days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | Pain will be measured in a pain diary at baseline, 1, 3, 6 and 12 weeks after treatment. In this diary patients will record their pain rate on a 11 point Box scale three times daily for a period of one week before each measurement point. |
| Secondary outcome measures | 1. Sensory complaints: a. McGill pain questionnaire will be used to obtain information about the type of pain experienced by patients b. Semmes Weinstein Monofilaments will be used to objectively measure sensitivity of the skin (e.g. hypesthesia, hyperesthesia and allodynia) 2. Impairments: patients functional status will be assessed with the Impairment Level Sumscore, in which: pain (measured by Box scale and McGill pain questionnaire), temperature (measured with infrared thermometer), volume (measured with water displacement volumeter) and active range of motion (measured with goniometers) will be converted into a compound sumscore 3. Functional disability: the Radboud Skills Questionnaire, the Walking Stairs Questionnaire and Questionnaire Rising and Sitting Down will be used to assess disability in patients with respectively upper and lower CRPS1 4. Quality of life: The 36-item Short Form (SF-36) and European Quality of Life (EuroQol) questionnaires will be used to measure quality of life Secondary outcomes will be measured at baseline, 1, 3, 6 and 12 weeks after treatment. |
| Overall study start date | 01/12/2006 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 72 |
| Total final enrolment | 56 |
| Key inclusion criteria | 1. Diagnostic criteria for Complex Regional Pain Syndrome type one (CRPS1) according to the International Association for the Study of Pain (IASP): a. presence of an initiating noxious event or cause for immobilisation b. continuing pain, allodynia or hyperalgesia, with which the pain is disproportioned to any inciting event and is not limited to the area of an individual peripheral nerve c. evidence at any time of oedema. Skin blood flow abnormality, or abnormal sudomotor activity in the painful area since the inciting event d. conditions which could otherwise account for the level of pain and dysfunction should be excluded Note: criteria b-d have to be met 2. A Visual Analogue Scale (VAS)-spontaneous pain score of 5 cm or higher 3. Patients should be between 18 to 70 years old 4. CRPS1 in one extremity 5. First time experience of patient with CRPS1 6. Other medication has to be stopped for more then one week before the trial starts 7. Patients should give written informed consent |
| Key exclusion criteria | 1. Not being able to give informed consent 2. Another (second) chronic pain syndrome, interfering with pain ratings 3. Another syndrome interfering with functional tests 4. CRPS1 in both hands or feet 5. Patient has experienced CRPS1 before 6. Known kidney and/or severe liver disease 7. Known nerve damage in the affected area 8. Active infection 9. Mental retardation 10. Psychiatric abnormality 11. Malignant disease 12. Patients with heart failure 13. Patients with pacemakers or implanted defibrillators 14. Patients with pulmonary congestion 15. Pregnancy |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Centre
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Government
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
No information available
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 | 01/09/2013 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
