Complex Regional Pain Syndrome (CRPS)NCT02753335
Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome
A study testing Individualized CRPS Rehabilitation in people with Complex Regional Pain Syndrome (CRPS), run by University Hospital of North Norway at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complex Regional Pain Syndrome (CRPS)
- What is being tested?
- Individualized CRPS Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to 15 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lena Danielsson, PhD contact
Kvarstein Gunnvald, PhD contact
Norway1 site, 1 recruiting
- Recruiting
University Hospital of North Norway
Tromsø, 9038
Lena Danielsson, +4777669307, lena.danielsson@unn.no
Gunnvald Kvarstein, gunnvald.kvarstein@unn.no
About this study
Official title: Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome: A Single-Case Experimental Design.
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.
Read the detailed description
The study comprises two complementary work packages (WPs).
Work Package 1 (WP1) uses a prospective randomized multiple-baseline single-case experimental design (SCED) to evaluate the rehabilitation process and clinical effects in individual participants with Complex Regional Pain Syndrome (CRPS). Participants are randomized to a baseline duration of 2, 3, or 4 weeks before the intervention is introduced. The rehabilitation combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and may be adjusted according to the participant's needs and response.
Repeated measurements of "How much has CRPS interfered with your daily activities during the past 24 hours?" and "How severe has your average pain been during the past 24 hours?" are collected throughout the study to evaluate changes within each participant and their temporal relationship to the introduction and adjustment of treatment. Validated measures of upper- or lower-limb function (QuickDASH or LEFS) are also collected repeatedly.
Additional standardized questionnaires are administered at baseline and 12 months to characterize the participants and to assess factors that may be associated with clinical and neuroimaging outcomes. These include measures of insomnia (ISI), psychological distress (HSCL-25), pain catastrophizing (PCS), self-efficacy (GSE), fatigue (CFQ), body perception disturbance (Bath CRPS Body Perception Disturbance Scale), neglect-like symptoms, and health-related quality of life (EQ-5D-5L).
Quantitative sensory testing (QST) is conducted to characterize sensory function, including thermal detection and pain thresholds. Neuropsychological testing is conducted to characterize general cognitive abilities, sustained attention, impulsivity, visuomotor reaction time, and executive functioning.
Work Package 2 (WP2) investigates brain structure and its relationship to CRPS using magnetic resonance imaging (MRI). MRI is performed at baseline and after 12 months. Structural brain characteristics, including gray matter morphology and white matter microstructure, in participants with CRPS will be compared with those of healthy controls. Longitudinal MRI will also be used to investigate structural brain changes over time in participants with CRPS and whether these changes are associated with limb function and pain intensity.
Together, the two work packages aim to improve understanding of individual clinical responses to rehabilitation and of structural brain characteristics and their potential changes over time in CRPS.
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Being tested
- Individualized CRPS Rehabilitation
- Keywords
- Complex Regional Pain Syndrome, CRPS, SCED, Graded Motor Imagery, Tactile Desensitization, Psychologically Informed Care, MRI
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized CRPS RehabilitationBehavioural
The rehabilitation intervention combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and adjusted according to the participant's needs, treatment response, and progression throughout the rehabilitation period.
GMI includes left/right discrimination training, motor imagery, and mirror therapy. The components are introduced and progressed flexibly according to the participant's individual abilities and response to treatment.
Tactile desensitization aims to reduce sensory hypersensitivity and improve tolerance of sensory input through repeated and gradually progressed tactile stimulation of the affected area using different materials and stimuli.
The PIC framework integrates physical rehabilitation with psychological principles and strategies addressing cognitive, emotional, and behavioral factors relevant to pain, movement, and daily functioning. The specific treatment components
| Study group | Role | What they receive |
|---|---|---|
| Individualized CRPS Rehabilitation | Experimental | Participants receive an individually tailored rehabilitation intervention combining Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. The intervention is adapted according to individual needs, treatment response, and progression throughout the rehabilitation period. Receives: Behavioral: Individualized CRPS Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRPS interference with daily activities
Participant-reported CRPS interference with daily activities, assessed using a single-item 0-10 Numeric Rating Scale (NRS): "How much has CRPS interfered with your daily activities during the past 24 hours?" Higher scores indicate greater interference (0 = not at all; 10 = to a very great extent). Repeated measurements are collected throughout the baseline and intervention phases as the primary target variable in the multiple-baseline single-case experimental design.
Measured: Throughout the baseline and intervention phases, up to 12 months
Secondary outcomes (6)
Average pain intensity
Participant-reported average pain intensity during the past 24 hours, assessed using a single-item 0-10 Numeric Rating Scale (NRS): "How severe has your average pain been during the past 24 hours?" The NRS ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity. Repeated measurements are collected throughout the baseline and intervention phases.
Measured: Throughout the baseline and intervention phases, up to 12 months
Lower extremity function (LEFS)
Lower extremity function assessed using the Lower Extremity Functional Scale (LEFS) in participants with CRPS affecting the lower extremity. The LEFS consists of 20 items assessing difficulty in performing everyday activities. Each item is scored from 0 to 4, giving a total score ranging from 0 to 80, with higher scores indicating better lower extremity function. The LEFS is assessed repeatedly throughout the study.
Measured: Repeatedly throughout the baseline and intervention phases, up to 12 months
Upper extremity function (QuickDASH)
Upper extremity function assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with CRPS affecting the upper extremity. The QuickDASH consists of 11 items assessing difficulty in performing activities and the impact of upper extremity symptoms. The total score ranges from 0 to 100, with higher scores indicating greater disability. The QuickDASH is assessed repeatedly throughout the study.
Measured: Repeatedly throughout the baseline and intervention phases, up to 12 months
CRPS severity (CRPS Severity Score)
CRPS severity assessed using the CRPS Severity Score (CSS), which comprises 16 clinical signs and symptoms of CRPS. Each item is scored as present (1) or absent (0), resulting in a total score ranging from 0 to 16, with higher scores indicating greater CRPS severity.
Measured: Baseline and 12 months
Gray matter brain morphology
Gray matter brain morphology assessed from structural MRI using FreeSurfer. MRI-derived measures in participants with CRPS will be compared with those of healthy controls at baseline. Longitudinal changes in participants with CRPS will also be assessed from baseline to 12 months.
Measured: Baseline and 12 months
White matter microstructure
White matter microstructure assessed using diffusion tensor imaging (DTI), including fractional anisotropy (FA), mean diffusivity (MD), and radial diffusivity (RD). White matter measures in participants with CRPS will be compared with those of healthy controls at baseline. Longitudinal changes in white matter microstructure will also be assessed in participants with CRPS from baseline to 12 months.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2030 (estimated)
- Study completion15 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome (CRPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multiple-baseline single-case experimental design (SCED). Participants are randomized to a baseline duration of 2, 3, or 4 weeks, resulting in staggered introduction of the intervention across participants. All participants receive the same overall rehabilitation approach, individually tailored according to their needs and response. Repeated measurements are collected throughout the baseline and intervention phases, allowing each participant to serve as their own control.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Örebro University, Sweden, The Royal Norwegian Ministry of Health, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Lena Danielsson, PhD, Study director, University Hospital og North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753335
- Sponsor's protocol ID
- 2014/1671(REK)
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2016
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krogstad IF, Danielsson L, Danielsson LP, Kvarstein G, Bergvik S. Patients' Experiences With Complex Regional Pain Syndrome (CRPS) and a Rehabilitation Program That Combines Graded Motor Imagery (GMI) and Tactile Desensitization (TD). Pain Res Manag. 2026;2026(1):e4480549. doi: 10.1155/prm/4480549.
PubMed 41925129Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.
PubMed 35579382
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome: A Single-Case Experimental Design.
- ClinicalTrials.gov ID
- NCT02753335
- Acronym / sponsor ID
- 2014/1671(REK)
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Keywords
- Complex Regional Pain Syndrome, CRPS, SCED, Graded Motor Imagery, Tactile Desensitization, Psychologically Informed Care, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Örebro University, Sweden, The Royal Norwegian Ministry of Health, University of Liverpool
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- 15 Nov 2032 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study comprises two complementary work packages (WPs).
Work Package 1 (WP1) uses a prospective randomized multiple-baseline single-case experimental design (SCED) to evaluate the rehabilitation process and clinical effects in individual participants with Complex Regional Pain Syndrome (CRPS). Participants are randomized to a baseline duration of 2, 3, or 4 weeks before the intervention is introduced. The rehabilitation combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and may be adjusted according to the participant's needs and response.
Repeated measurements of "How much has CRPS interfered with your daily activities during the past 24 hours?" and "How severe has your average pain been during the past 24 hours?" are collected throughout the study to evaluate changes within each participant and their temporal relationship to the introduction and adjustment of treatment. Validated measures of upper- or lower-limb function (QuickDASH or LEFS) are also collected repeatedly.
Additional standardized questionnaires are administered at baseline and 12 months to characterize the participants and to assess factors that may be associated with clinical and neuroimaging outcomes. These include measures of insomnia (ISI), psychological distress (HSCL-25), pain catastrophizing (PCS), self-efficacy (GSE), fatigue (CFQ), body perception disturbance (Bath CRPS Body Perception Disturbance Scale), neglect-like symptoms, and health-related quality of life (EQ-5D-5L).
Quantitative sensory testing (QST) is conducted to characterize sensory function, including thermal detection and pain thresholds. Neuropsychological testing is conducted to characterize general cognitive abilities, sustained attention, impulsivity, visuomotor reaction time, and executive functioning.
Work Package 2 (WP2) investigates brain structure and its relationship to CRPS using magnetic resonance imaging (MRI). MRI is performed at baseline and after 12 months. Structural brain characteristics, including gray matter morphology and white matter microstructure, in participants with CRPS will be compared with those of healthy controls. Longitudinal MRI will also be used to investigate structural brain changes over time in participants with CRPS and whether these changes are associated with limb function and pain intensity.
Together, the two work packages aim to improve understanding of individual clinical responses to rehabilitation and of structural brain characteristics and their potential changes over time in CRPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multiple-baseline single-case experimental design (SCED). Participants are randomized to a baseline duration of 2, 3, or 4 weeks, resulting in staggered introduction of the intervention across participants. All participants receive the same overall rehabilitation approach, individually tailored according to their needs and response. Repeated measurements are collected throughout the baseline and intervention phases, allowing each participant to serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Individualized CRPS Rehabilitation | Experimental | Behavioral: Individualized CRPS RehabilitationParticipants receive an individually tailored rehabilitation intervention combining Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. The intervention is adapted according to individual needs, treatment response, and progression throughout the rehabilitation period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized CRPS RehabilitationThe rehabilitation intervention combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and adjusted according to the participant's needs, treatment response, and progression throughout the rehabilitation period. GMI includes left/right discrimination training, motor imagery, and mirror therapy. The components are introduced and progressed flexibly according to the participant's individual abilities and response to treatment. Tactile desensitization aims to reduce sensory hypersensitivity and improve tolerance of sensory input through repeated and gradually progressed tactile stimulation of the affected area using different materials and stimuli. The PIC framework integrates physical rehabilitation with psychological principles and strategies addressing cognitive, emotional, and behavioral factors relevant to pain, movement, and daily functioning. The specific treatment components | Behavioural | Individualized CRPS Rehabilitation |
Primary outcome
CRPS interference with daily activities
Time frame: Throughout the baseline and intervention phases, up to 12 months
Participant-reported CRPS interference with daily activities, assessed using a single-item 0-10 Numeric Rating Scale (NRS): "How much has CRPS interfered with your daily activities during the past 24 hours?" Higher scores indicate greater interference (0 = not at all; 10 = to a very great extent). Repeated measurements are collected throughout the baseline and intervention phases as the primary target variable in the multiple-baseline single-case experimental design.
6 secondary outcomes
Average pain intensity
Time frame: Throughout the baseline and intervention phases, up to 12 months
Lower extremity function (LEFS)
Time frame: Repeatedly throughout the baseline and intervention phases, up to 12 months
Upper extremity function (QuickDASH)
Time frame: Repeatedly throughout the baseline and intervention phases, up to 12 months
CRPS severity (CRPS Severity Score)
Time frame: Baseline and 12 months
Gray matter brain morphology
Time frame: Baseline and 12 months
White matter microstructure
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 41925129Krogstad IF, Danielsson L, Danielsson LP, Kvarstein G, Bergvik S. Patients' Experiences With Complex Regional Pain Syndrome (CRPS) and a Rehabilitation Program That Combines Graded Motor Imagery (GMI) and Tactile Desensitization (TD). Pain Res Manag. 2026;2026(1):e4480549. doi: 10.1155/prm/4480549.
- Derived from this study: PubMed 35579382Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena Danielsson, PhD contact
Kvarstein Gunnvald, PhD contact
Lena Danielsson, PhD study director
University Hospital og North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized CRPS Rehabilitation in people with Complex Regional Pain Syndrome (CRPS), run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Danielsson, PhD (lena.danielsson@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRPS interference with daily activities (time frame: Throughout the baseline and intervention phases, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753335, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.