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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOulu University Hospital

About this trial

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 CRPS patients almost always have to substantially reduce their work hours or withdrawn from the workforce for extended periods, and often permanently, increasing the urgency of strengthening rehabilitation approaches; a CRPS symptoms can end a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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Device

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

  • Basic physical therapy treatment

    Other intervention

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

  • Functional neurology

    Other intervention

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

  • Optimizing the medication

    Drug

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

Treatment groups

156 Participants
are divided into 4 treatment groups
Group A: Control groupActive comparator 4 interventions
Group B: Early functional neurological rehabilitationExperimental treatment 4 interventions
Group C: Early maximal rehabilitationExperimental treatment 3 interventions
Group D: Basic treatment protocolOther 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Enrollment, 6, 12 and 36 months.
2

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.

Time frame
Enrollment, 6, 12 and 36 months

Secondary outcomes

1

Jenkis sleep questionnaire

a four-item self-report instrument designed to efficiently screen for the frequency and intensity of common sleep disturbances

Time frame
Enrollment, 6, 12 and 36 months. During the rTMS treatment
2

Amount of sleep

Open question on average hours of sleep during the last week

Time frame
Enrollment, 6, 12 and 36 months. During the rTMS treatment
3

Beck Depression Inventory

a 21-item, self-report questionnaire designed to screen for and measure the severity of depression in adults and adolescents

Time frame
Enrollment, 6, 12 and 36 months
4

DEPS

10 item depression questionnaire

Time frame
Enrollment, 6, 12 and 36 months

Other outcomes

1

General well-being question

Open question

Time frame
ENrollment, 6, 12 and 36 months
2

Tampa Scale of Kinesiophobia

a 17-item self-report questionnaire designed to measure fear of movement or re-injury, particularly in patients with chronic pain

Time frame
Enrollment, 6, 12 and 36 months
3

Right-left discrimination

the ability to differentiate between the left and right sides of one's body and the external world (test is performed with iPad)

Time frame
Enrollment, 6, 12 months
4

Two-point discrimination

a neurological assessment of tactile spatial acuity, measuring the ability to perceive two simultaneous points of touch as separate rather than one (affected and non-affected limb)

Time frame
Enrollment, 6, 12 months

Sponsors and contacts

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Oulu University Hospital

Lead sponsor

The Maud Kuistila Memorial Foundation

Collaborator