Complex Regional Pain SyndromesTORNADONCT04597866
Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up
An observational study of Complex Regional Pain Syndromes and Chronic Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complex Regional Pain Syndromes, Chronic Pain
- What is being tested?
- Multimodal rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 21 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Subjects with CRPS 1 or 2, diagnosed according to the Budapest criteria that has received in-patient treatment at Uppsala University Hospital, comprised of graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation.
Who may be able to join
- Has participated in multimodal treatment for CRPS at Uppsala University Hospital
Who cannot join
- Other serious physical or mental condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up
Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified.
A combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS.
The present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.
- Conditions
- Complex Regional Pain Syndromes, Chronic Pain
- Being tested
- Multimodal rehabilitation
- Medical subject headings
- Complex Regional Pain Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal rehabilitationBehavioural
A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.
| Study group | Role | What they receive |
|---|---|---|
| CRPS | Not described Receives: Behavioral: Multimodal rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis
Whether the subject still fulfill diagnostic criteria for CRPS
Measured: 1 day
Subjective experience
A qualitative interview targeting the subjects own experience of the treatment and its effect
Measured: 1 day
Secondary outcomes (10)
Level of pain
Subjective level of pain on a Likert-scale 0-10 (NRS)
Measured: 1 day
Subjective experience of quality of life
Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)
Measured: 1 day
Global impression of change
Global impression of change measured with a single question (0-6, higher scores mean a better outcome)
Measured: 1 day
Acceptance of pain
Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)
Measured: 1 day (0-156, higher scores mean a better outcome)
Fear of pain
Measured with the Tampa Scale of Kinesiophobia, TSK (0-52, lower scores mean a better outcome)
Measured: 1 day (0-52, lower scores mean a better outcome)
Pain catastrophizing
Measured with Pain Catastrophizing Scale, PCS (0-52, lower scores mean a better outcome)
Measured: 1 day (0-52, lower scores mean a better outcome)
Avoidance of activities
Measured with the Photograph Series of Daily Activities, PHODA (0-100, lower scores mean a better outcome)
Measured: 1 day (0-100, lower scores mean a better outcome)
Neglect of the affected limb
Measured with a five item questionnaire (0-36, lower scores mean a better outcome)
Measured: 1 day (0-36, lower scores mean a better outcome)
Subjective experience of quality of life 2
EuroQol 5D, EQ-5D (0-15, higher scores means a better outcome)
Measured: 1 day
Subjective experience of quality of life 3
Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Sep 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristoffer Bothelius, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597866
- Sponsor's protocol ID
- 2020-03383
- Acronym
- TORNADO
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up
- ClinicalTrials.gov ID
- NCT04597866
- Acronym / sponsor ID
- TORNADO / 2020-03383
- Conditions
- Complex Regional Pain Syndromes, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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.
Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified.
A combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS.
The present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRPS | – | Behavioral: Multimodal rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with CRPS 1 or 2, diagnosed according to the Budapest criteria that has received in-patient treatment at Uppsala University Hospital, comprised of graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation.
Key inclusion criteria (1 listed)
- Has participated in multimodal treatment for CRPS at Uppsala University Hospital
Key exclusion criteria (1 listed)
- Other serious physical or mental condition
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 |
|---|---|---|
| Multimodal rehabilitationA combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS. | Behavioural | CRPS |
Primary outcome
Diagnosis
Time frame: 1 day
Whether the subject still fulfill diagnostic criteria for CRPS
Subjective experience
Time frame: 1 day
A qualitative interview targeting the subjects own experience of the treatment and its effect
10 secondary outcomes
Level of pain
Time frame: 1 day
Subjective experience of quality of life
Time frame: 1 day
Global impression of change
Time frame: 1 day
Acceptance of pain
Time frame: 1 day (0-156, higher scores mean a better outcome)
Fear of pain
Time frame: 1 day (0-52, lower scores mean a better outcome)
Pain catastrophizing
Time frame: 1 day (0-52, lower scores mean a better outcome)
Avoidance of activities
Time frame: 1 day (0-100, lower scores mean a better outcome)
Neglect of the affected limb
Time frame: 1 day (0-36, lower scores mean a better outcome)
Subjective experience of quality of life 2
Time frame: 1 day
Subjective experience of quality of life 3
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Complex Regional Pain Syndromes
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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. This study is not recruiting at the moment.
Kristoffer Bothelius, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndromes and Chronic Pain, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.