The Effectiveness of Individualized Physical Therapy and Functional Neurology Treatment Protocol in Conjunction With Optimizing Medication and Repetitive Transcranical Magnetic Stimulation in Patients With Complex Regional Pain Syndrome.

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the study is to investigate and improve non-pharmacological rehabilitation methods for patients with Complex Regional Pain Syndrome (CRPS) to reduce pain and restore work and functional capacity to lower overall treatment costs. Current treatment methods offer limited rehabilitation potential for this challenging pain condition, so efforts should be made to raise the level of care and rehabilitation for a disease that often causes long-term and severe reductions in patients' functional and occupational abilities. CRPS patients almost always have to substantially reduce their work hours or withdrawn from the workforce for extended periods, and often permanently, increasing the urgency of strengthening rehabilitation approaches; a CRPS symptoms can end a patient's productivity for society. In addition, commonly used medications are a significant expense for both individuals and the healthcare system. CRPS rarely resolves fully, and even with extensive rehabilitation only a small proportion of patients regain sufficient improvement to return to work at a level of at least 60% capacity. Participants will be recruited from the Department of Physical Medicine and Rehabilitation at Oulu University Hospital, where CRPS diagnostics for the Northern Ostrobothnia area are primarily conducted. The study will be carried out at OYS rehabilitation outpatient clinics. A total of 39 participants will be recruited into each of four study groups, for an overall sample size of 156 individuals. Each study group will receive repetitive transcranial magnetic stimulation (rTMS) at some point, and functional neurological rehabilitation will be combined with rTMS in varying ways (content and timing will differ between groups). All participants will receive basic CRPS rehabilitation (physiotherapy and occupational therapy) that is provided for all RPS patients, and the timing of this relative to rTMS will also be varied. Recruitment is planned to begin in a autumn 2025.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• CRPS symptoms maximum of 5 year at the time of diagnosis (CRPS 1 and 2)

• 18 to 70-year-old

• rTMS treatment is granted by university hospital pain clinic (by multidisciplinary group)

• Voluntary to participate into the study

Locations
Other Locations
Finland
Oulu University Hospital, Pain Clinic
RECRUITING
Oulu
Contact Information
Primary
Jani M Takatalo, PhD, MD, PRM Specialit
oysfysiatriatutkimus@gmail.com
+358 8 315 2129
Backup
Juhani Määttä, Docent, MD, PRM Specialist
oysfysiatriatutkimus@gmail.com
+358 8 315 2129
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 156
Treatments
Active_comparator: Control group
Optimizing medication (6mo) followed by rTMS and basic physical therapy rehabilitation (6mo)
Experimental: Early functional neurological rehabilitation
Early functional neurological rehabilitation with optimizing medication (6mo) followed by rTMS and basic physical therapy rehabilitation (6mo)
Experimental: Early maximal rehabilitation
Early functional neurological and physical therapy rehabilitation with optimizing medication (6mo) followed by rTMS (6mo)
Other: Basic treatment protocol
Early physical therapy rehabilitation with optimizing medication (6mo) followed by rTMS (6mo)
Related Therapeutic Areas
Sponsors
Leads: Oulu University Hospital
Collaborators: The Maud Kuistila Memorial Foundation

This content was sourced from clinicaltrials.gov