NCT03174249

Brief Summary

Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are treated with graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

March 28, 2017

Last Update Submit

May 30, 2017

Conditions

Complex Regional Pain Syndromes

Keywords

Behavioural therapyExposure in vivoCortical reorganisationMirror therapy

Outcome Measures

Primary Outcomes (1)

  • Photograph series of daily activities, PHODA

    A measure of avoidance of activities - the subject reports level of hesitation in performing a number of everyday activities on a 0-100 rating scale.

    12 weeks

Secondary Outcomes (1)

  • The Tampa Scale of Kinesiophobia - Short Form, TSK-SF

    12 weeks

Study Arms (1)

Exposure therapy

EXPERIMENTAL

Graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Behavioral: Exposure therapy

Interventions

Exposure therapyBEHAVIORAL

Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.

Also known as: Mirror therapy, Desensibilisation training, Sensory re-education
Exposure therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complex regional pain syndrome II

You may not qualify if:

  • Severe psychiatric disorder drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Implosive TherapyMirror Movement Therapy

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPhysical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Torsten Gordh, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A series of case-studies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

June 2, 2017

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)