CRPS-1-2011-2014

Aalto University, Department of Neuroscience and Biomedical Engineering

Aalto University School of Science, P.O. Box 12200, Finland, FI-00076 AALTO

Academic coordinator, Aalto University, Department of Neuroscience and Biomedical Engineering, +358 947001,

Academic coordinator, Aalto University, Department of Neuroscience and Biomedical Engineering, +358 947001,

HUS, Pain Clinic

PL 612, Helsinki, Finland, 00029 HUS

Nurse Manager, HUS, Pain Clinic, +358 94711,

Nurse Manager, HUS, Pain Clinic, +358 94711,

No

No

No

Final

30 Dec 2017

Yes

06 May 2014

Yes

06 May 2014

No

The main objective of the trial is to explore the alterations in brain function and structure and the effect of trial treatment on these changes and patient symptoms.

Trial subjects were informed of study protocol including medication and imaging procedures and that they are able to terminate the study or any test at any point without a need to explain their decision. Patients were informed of the possible side effects and they were instructed to keep a diary and inform research personel on any possible side effects. If any side effects were to occur, they would be taken care of accordingly. The suitability of study medicines for the subjects were handled by participant exclusion criteria. The medication was initiated by increasing the dosage slowly to minimize side-effects. All the stimuli applied in this study were painless and harmless.

01 Jan 2011

No

No

Finland: 10

10

10

0

0

0

0

0

0

10

0

0

Overall trial (overall period)

Not applicable

MORPHINE HYDROCHLORIDE TRIHYDRATE

Tablet

Oral use

First, the patients started with oral morphine 10 mg daily and increased the dose every 3 days to 10 mg three times a day, if tolerated. After 12 weeks, medication was discontinued.

MEMANTINE HYDROCHLORIDE

Tablet

Oral use

First, the patients started with oral morphine 10 mg daily and increased the dose every 3 days to 10 mg three times a day, if tolerated. After a week, oral memantine 5 mg daily was added and the dose was every 3 days increased up to 40 mg per day, if tolerated. Patients used medication altogether 12 weeks, after which they discontinued the medication.

Overall trial

Symptom reduction and improved function in chronic CRPS type 1

The patients were recruited mainly from the Pain Clinic of the Helsinki University Hospital and from two other Hospitals at the Uusimaa district as part of a larger CRPS study which included MRI and video experiments [16], [17], [18], [19]. Inclusion criteria were age from 18 to 65, CRPS type 1 (Budapest criteria [1]) in the upper limb for at least 6 months, and during the past week the maximum intensity of pain more than four on a 11-point numeric rating scale (NRS 0–10, 0=no pain, 10=extreme pain). Exclusion criteria were major psychiatric or neurological diseases and alcohol or drug abuse by self-report. Additionally, no previous use of memantine, which was part of the study medication, was allowed and mild opioids were tapered down before study medication.

Medication

Symptom reduction and improved function in chronic CRPS type 1

The patients were recruited mainly from the Pain Clinic of the Helsinki University Hospital and from two other Hospitals at the Uusimaa district as part of a larger CRPS study which included MRI and video experiments [16], [17], [18], [19]. Inclusion criteria were age from 18 to 65, CRPS type 1 (Budapest criteria [1]) in the upper limb for at least 6 months, and during the past week the maximum intensity of pain more than four on a 11-point numeric rating scale (NRS 0–10, 0=no pain, 10=extreme pain). Exclusion criteria were major psychiatric or neurological diseases and alcohol or drug abuse by self-report. Additionally, no previous use of memantine, which was part of the study medication, was allowed and mild opioids were tapered down before study medication.

For CRPS symptom count, patients reported on a questionnaire with dichotomous scale (0=no, 1=yes) the presence of the following symptoms of the affected limb: hyperalgesia, allodynia, swelling, abnormal sweating, movement restriction, weakness, tremor, dystonic postures, trophic changes in skin, nails, or hair, differences in temperature or color, or changes in color.

Primary

Pre- and post-intervention.

To summarize effects of the intervention, we combined data from the motor tests, pain ratings, and psychological questionnaires into a single subject-wise index. First, change in each was transformed to a categorical variable of 1, 0 or −1, representing improvement, no change, or deterioration respectively. Then the subject-wise index was calculated as the mean of these categorical variables. The indices were tested in the group statistics against 0 with a one-sample Wilcoxon signed-rank test.

Medication v Symptom reduction and improved function in chronic CRPS type 1

20

Pre-specified

During intervention.

None of the patients were able to complete the pharmacological intervention quite as planned. In all patients, the dose or duration of study medication had to be diminished due to side-effects. Overall, patients reported 9.5±3.3 (mean±SD; range 6–15) different adverse events with a mean severity of 3.3±1.3 (1–9; NRS-11).

0

All subjects