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CompletedNCT04597866TORNADOUpdated Feb 28, 2024

Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up

An observational study in Complex Regional Pain Syndromes and Chronic Pain, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Has participated in multimodal treatment for CRPS at Uppsala University Hospital

Exclusion criteria

Exclusion Criteria:

  • Other serious physical or mental condition
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • CRPS

    Behavioral: Multimodal rehabilitation

Interventions

  • BehavioralMultimodal rehabilitation

    A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.

05

What researchers measure

Primary outcomes

  1. Diagnosis

    Whether the subject still fulfill diagnostic criteria for CRPS

    Time frame: 1 day

  2. Subjective experience

    A qualitative interview targeting the subjects own experience of the treatment and its effect

    Time frame: 1 day

Secondary outcomes

  1. Level of pain

    Subjective level of pain on a Likert-scale 0-10 (NRS)

    Time frame: 1 day

  2. Subjective experience of quality of life

    Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)

    Time frame: 1 day

  3. Global impression of change

    Global impression of change measured with a single question (0-6, higher scores mean a better outcome)

    Time frame: 1 day

  4. Acceptance of pain

    Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)

    Time frame: 1 day (0-156, higher scores mean a better outcome)

  5. Fear of pain

    Measured with the Tampa Scale of Kinesiophobia, TSK (0-52, lower scores mean a better outcome)

    Time frame: 1 day (0-52, lower scores mean a better outcome)

  6. Pain catastrophizing

    Measured with Pain Catastrophizing Scale, PCS (0-52, lower scores mean a better outcome)

    Time frame: 1 day (0-52, lower scores mean a better outcome)

  7. Avoidance of activities

    Measured with the Photograph Series of Daily Activities, PHODA (0-100, lower scores mean a better outcome)

    Time frame: 1 day (0-100, lower scores mean a better outcome)

  8. Neglect of the affected limb

    Measured with a five item questionnaire (0-36, lower scores mean a better outcome)

    Time frame: 1 day (0-36, lower scores mean a better outcome)

  9. Subjective experience of quality of life 2

    EuroQol 5D, EQ-5D (0-15, higher scores means a better outcome)

    Time frame: 1 day

  10. Subjective experience of quality of life 3

    Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)

    Time frame: 1 day

06

Study locations

1 site
  • Uppsala University
    Uppsala, 75185, Sweden
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04597866
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Sep 21, 2020
Primary completion
Jun 30, 2021
Completion
Dec 31, 2021
Last update
Feb 28, 2024

Study contacts

Kristoffer Bothelius, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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