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Completed

NCT Number: NCT04597866

Treatment of Complex Regional Pain Syndrome, a 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.

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Chronic Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, 75185, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other serious physical or mental condition

Treatment and study plan

Multimodal rehabilitation

Behavioral

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

Primary outcomes

  1. Diagnosis

    Time frame: 1 day

    Whether the subject still fulfill diagnostic criteria for CRPS

  2. Subjective experience

    Time frame: 1 day

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

Secondary outcomes

  1. Level of pain

    Time frame: 1 day

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

  2. Subjective experience of quality of life

    Time frame: 1 day

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

  3. Global impression of change

    Time frame: 1 day

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

  4. Acceptance of pain

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

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

  5. Fear of pain

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

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

  6. Pain catastrophizing

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

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

  7. Avoidance of activities

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

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

  8. Neglect of the affected limb

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

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

  9. Subjective experience of quality of life 2

    Time frame: 1 day

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

  10. Subjective experience of quality of life 3

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up

Acronym: TORNADO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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