RecruitingNot ApplicableNCT07208825

The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.

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.


Sponsor

Oulu University Hospital

Enrollment

156 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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 CRPS patients almost always have to substantially reduce their work hours or withdrawn from the workforce for extended periods, and often permanently, increasing the urgency of strengthening rehabilitation approaches; a CRPS symptoms can end a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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • CRPS symptoms maximum of 5 year at the time of diagnosis (CRPS 1 and 2)
  • to 70-year-old
  • rTMS treatment is granted by university hospital pain clinic (by multidisciplinary group)
  • Voluntary to participate into the study

Exclusion Criteria4

  • CRPS symptoms started over five years ago (although diagnosed first time now)
  • No other outpatient/inpatient rehabilitation during the study rehabilitation period (insurance company or other third party)
  • Under 18-years-old of over 70-years-old
  • No eligible to rTMS treatment or for other reason rTMS treatment was not granted by university hospital pain clinic (by multidisciplinary group)

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Interventions

DEVICErTMS

2 weeks starting period (10 treatment days) followed by 5 treatment once a month.

OTHERBasic physical therapy treatment

10 sessions with physical (or occupational) therapist with special education for treating CRPS

OTHERFunctional neurology

4 to 6 sessions with specialized OMT-physical therapist who will aim to improve the neurological deficits of the CRPS patient

DRUGOptimizing the medication

Aim is to optimize the medication of the CRPS patient according the the medication guidelines


Locations(1)

Oulu University Hospital, Pain Clinic

Oulu, North Ostrobothnia, Finland

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NCT07208825


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