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

NCT07208825 | Recruiting

• 1 other identifier: EETTMK: 6/2024
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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 CRPS patients almost always have to substantially reduce their work hours or withdrawn from the workforce for extended periods, and often permanently, increasing the urgency of strengthening rehabilitation approaches; a CRPS symptoms can end a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

Conditions

CRPS (Complex Regional Pain Syndromes)

Keywords

CRPS; GMI; Graded motor imaginary; Rehabilitation; Functional neurology; rTMS; medication

Outcome Measures

Primary Outcomes (2)

• Patient specific functional scale (PSFS)

  Patient names three important tasks that are compromised by the CRPS and label them by number (from 0 to 10) according the to the ability to perform them at the day of evaluation. Higher the number, better the function (from 0 to 30)

  Enrollment, 6, 12 and 36 months.

• Visual analog scale (VAS)

  Participant is asked to mark with a vertical line the pain experienced during the day of evaluation into the 10cm horizontal line.

  Enrollment, 6, 12 and 36 months

Secondary Outcomes (6)

• Jenkis sleep questionnaire

  Enrollment, 6, 12 and 36 months. During the rTMS treatment

• Amount of sleep

  Enrollment, 6, 12 and 36 months. During the rTMS treatment

• Beck Depression Inventory

  Enrollment, 6, 12 and 36 months

• DEPS

  Enrollment, 6, 12 and 36 months

• Pain Self-Efficacy Questionnaire (PSEQ)

  Enrollment, 6, 12 and 36 months

Other Outcomes (4)

• General well-being question

  ENrollment, 6, 12 and 36 months

• Tampa Scale of Kinesiophobia

  Enrollment, 6, 12 and 36 months

• Right-left discrimination

  Enrollment, 6, 12 months

Study Arms (4)

Control group

ACTIVE COMPARATOR

Optimizing medication (6mo) followed by rTMS and basic physical therapy rehabilitation (6mo)

Device: rTMS; Other: Basic physical therapy treatment; Other: Functional neurology; Drug: Optimizing the medication

Early functional neurological rehabilitation

EXPERIMENTAL

Early functional neurological rehabilitation with optimizing medication (6mo) followed by rTMS and basic physical therapy rehabilitation (6mo)

Device: rTMS; Other: Basic physical therapy treatment; Other: Functional neurology; Drug: Optimizing the medication

Early maximal rehabilitation

EXPERIMENTAL

Early functional neurological and physical therapy rehabilitation with optimizing medication (6mo) followed by rTMS (6mo)

Device: rTMS; Other: Basic physical therapy treatment; Drug: Optimizing the medication

Basic treatment protocol

OTHER

Early physical therapy rehabilitation with optimizing medication (6mo) followed by rTMS (6mo)

Device: rTMS; Other: Basic physical therapy treatment; Drug: Optimizing the medication

Interventions

rTMS DEVICE

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

Basic treatment protocol; Control group; Early functional neurological rehabilitation; Early maximal rehabilitation

Basic physical therapy treatment OTHER

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

Basic treatment protocol; Control group; Early functional neurological rehabilitation; Early maximal rehabilitation

Functional neurology OTHER

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

Control group; Early functional neurological rehabilitation

Optimizing the medication DRUG

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

Basic treatment protocol; Control group; Early functional neurological rehabilitation; Early maximal rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oulu University Hospital: lead
• The Maud Kuistila Memorial Foundation: collaborator

Study Sites (1)

Oulu University Hospital, Pain Clinic

Oulu, North Ostrobothnia, 90100, Finland

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Jani M Takatalo, PhD, MD, PRM Specialist

  Oulu University Hospital, Pain Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jani M Takatalo, PhD, MD, PRM Specialit

CONTACT

+358 8 315 2129; oysfysiatriatutkimus@gmail.com

Juhani Määttä, Docent, MD, PRM Specialist

CONTACT

+358 8 315 2129; oysfysiatriatutkimus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Some care providers (rTMS)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Pain Clinic

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2033
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

FI (1)