NCT02753335 Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome
| NCT ID | NCT02753335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of North Norway |
| Condition | Complex Regional Pain Syndrome (CRPS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2016-09 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2016-09 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates the clinical effects of an individually tailored rehabilitation program for patients with Complex Regional Pain Syndrome (CRPS). A randomized multiple-baseline single-case experimental design (SCED) will be used to evaluate individual changes in CRPS interference with daily activities, pain, and limb function during rehabilitation. Treatment components will be adjusted according to each participant's needs and response to treatment. The study will also use magnetic resonance imaging (MRI) to investigate brain structure in patients with CRPS compared with healthy controls and to examine whether brain structure changes over time in patients with CRPS.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older. For participants included in WP2 (MRI), the maximum age is 70 years. * Diagnosis of Complex Regional Pain Syndrome (CRPS) according to the Budapest criteria. * CRPS affecting a single upper or lower limb. * Triggering trauma or onset of pain more than 3 months before inclusion. Exclusion Criteria: * Drug abuse. * Malignant or progressive disease, systemic disease, or neurodegenerative disease. * Other severe pain conditions. * Severe anxiety or depression. * Disabling fatigue or myalgic encephalomyelitis (ME). * Use of opioid medication exceeding 100 mg oral morphine equivalents (OMEQ). Additional Exclusion Criteria for WP2 (MRI): * History of seizures. * Neurological or neurosurgical disorders. * Significant cardiac or systemic illness. * Implanted metallic or electronic devices incompatible with MRI. * Diagnosis of a developmental disorder. * Current use of antipsychotic medications, benzodiazepines, or other pharmacological agents that may influence MRI measurements. * Pregnancy or lactation. * Phobia of MRI examination.
Contact & Investigator
Lena Danielsson, PhD
✉ lena.danielsson@unn.noLena Danielsson, PhD
STUDY DIRECTOR
University Hospital og North Norway
Frequently Asked Questions
Who can join the NCT02753335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Complex Regional Pain Syndrome (CRPS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02753335 currently recruiting?
Yes, NCT02753335 is actively recruiting participants. Contact the research team at lena.danielsson@unn.no for enrollment information.
Where is the NCT02753335 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT02753335 clinical trial?
NCT02753335 is sponsored by University Hospital of North Norway. The principal investigator is Lena Danielsson, PhD at University Hospital og North Norway. The trial plans to enroll 12 participants.