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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Complex Regional Pain Syndromes
• Intervention / Treatment: Behavioral: Multimodal rehabilitation

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Other serious physical or mental condition

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRPS	Behavioral: Multimodal rehabilitation; A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis	Whether the subject still fulfill diagnostic criteria for CRPS	1 day
Subjective experience	A qualitative interview targeting the subjects own experience of the treatment and its effect	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pain	Subjective level of pain on a Likert-scale 0-10 (NRS)	1 day
Subjective experience of quality of life	Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)	1 day
Global impression of change	Global impression of change measured with a single question (0-6, higher scores mean a better outcome)	1 day
Acceptance of pain	Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)	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)	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)	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)	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)	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)	1 day
Subjective experience of quality of life 3	Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)	1 day

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Kristoffer Bothelius, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 2020-03383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No