CRPS - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation
Transcranial Magnetic Stimulation, Complex Regional Pain Syndrome of Upper Limb (Disorder)
About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring TMS, CRPS, pain, fMRI, quality of life, mood, cognitive function, DNA
Eligibility Criteria
Inclusion Criteria:
- CRPS 1 or 2 of the upper limb
- Duration ≥ 6 months
- Mean pain (NRS) intensity ≥5/10
- Medical and other therapies have failed
Exclusion Criteria:
- Other stimulation therapies apart from transcutaneous nerve stimulation
- psychotic disorder
- severe depression
- use of strong opioids
- epilepsy
- any contraindication for MRI
- abuse of alcohol or drugs
- ongoing insurance or other entitlement cases
Sites / Locations
- Helsinki University Hospital, Pain Clinic
- Turku University Hospital, Pain Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Starts with active stimulation
Starts with sham stimulation
Active nrTMS is given to "S2" at the right side (10 sessions in a three week period). Thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to M1 contralateral to the side of pain. After 5 stimulation sessions the response is evaluated. If pain is still ≥510, the investigators change the target to the "S2" on the left side for five sessions. If there is response with pain relief, a maintenance therapy with this target is offered for 6 months with gradually reducing stimulation sessions.
Sham nrTMS will be targeted to the "S2" on the right side, but using a sham box/coil. Stimulation period is similar than for the active comparator. Similarly, thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to "S2" at the right side. After 5 stimulation sessions the response is evaluated. If pain is still ≥5/10, the investigators change the target to M1 on the contralateral side of the pain and furthermore to "S2" at the left side after 5 stimulation sessions, if pain is still ≥5/10.