Back to resultsSingle-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
Primary Purpose
Complex Regional Pain Syndrome Type I of the Upper Limb
Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
unilateral single-port VATS sympathicotomy
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome Type I of the Upper Limb
Eligibility Criteria
Inclusion Criteria:
Age 18 - 65 years.
- ASA 1 en 2.
CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.
- Continuing pain which is disproportionate to any inciting event
Must report at least one symptom in each of the four following categories
- Sensory: reports of hyperesthesia
- Vasomotor: reports of temperature asymmetry, skin color change or asymmetry.
- Sudomotor/edema: reports of edema, sweating changes, sweating asymmetry
- Motor/trophic: reports of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
Must display at least one sign in two or more of the following categories:
- Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
- Vasomotor: evidence of temperature asymmetry, color changes, asymmetry
- Sudomotor/edema: evidence of edema, sweating changes, sweating asymmetry
- Motor/trophic: evidence of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
Exclusion Criteria:
Known COPD > Gold class 1.
- History of smoking > 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
- Documented substance addiction.
- Previous intra-thoracic pleural drainage on affected side.
- Previous thoracic surgery on affected side (including sternotomy). - Gross pulmonary or pleural abnormalities on chest X-ray.
- Pregnancy, determined by preoperative pregnancy test.
- Unsuitable anatomy (e.g. due to severe physical malformations).
Sites / Locations
- University Medical Centre Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sympathicotomy
Arm Description
unilateral single-port VATS sympathicotomy
Outcomes
Primary Outcome Measures
Change in perceived pain measured in Visual Analogue Scale
Secondary Outcome Measures
Change in function in extremity
Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.
Full Information
NCT ID
NCT01886625
First Posted
March 24, 2013
Last Updated
February 8, 2016
Sponsor
University of Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01886625
Brief Title
Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
Official Title
Single-port Thoracoscopic Sympathicotomy for Treatment of Complex Regional Pain Syndrome Type I, a Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No local inclusions
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Groningen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background of the study: CRPS type-1 is a pain syndrome that usually develops after an initiating noxious event (e.g. fracture) in an extremity. Although treatment options life dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical therapy exist, the treatment effect is often unsatisfactory, even leading to amputation of the extremity. Surgical treatment of chronic pain disorders by dividing the sympathetic chain is an established treatment. Its more invasive nature has prevented widespread application. After introduction of minimal invasive techniques in recent years, the UMCG has now devised a truly minimal invasive, yet safe and effective thoracoscopic technique, that requires only a single 1 cm long incision in the anterior axillary line. This technique is developed as treatment for primary focal axillary and palmar hyperhidrosis, and is performed in over 50 patients producing very satisfying results. This fact has led to the hypothesis that this same surgical technique can offer this group of chronic pain patients a safe, effective treatment modality.
Objective of the study: The effect of the intervention on pain an regain of function in de affected extremity. This will be quantified in multiple questionnaires at baseline and three follow-up points, and by clinical evaluation of the hand function at baseline and two follow-up points.
Study design: Single center prospective feasibility study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome Type I of the Upper Limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sympathicotomy
Arm Type
Experimental
Arm Description
unilateral single-port VATS sympathicotomy
Intervention Type
Procedure
Intervention Name(s)
unilateral single-port VATS sympathicotomy
Primary Outcome Measure Information:
Title
Change in perceived pain measured in Visual Analogue Scale
Time Frame
Baseline, 1, 3 and 6 months postoperative
Secondary Outcome Measure Information:
Title
Change in function in extremity
Description
Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.
Time Frame
Baseline, 1 and 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 - 65 years.
ASA 1 en 2.
CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.
Continuing pain which is disproportionate to any inciting event
Must report at least one symptom in each of the four following categories
Sensory: reports of hyperesthesia
Vasomotor: reports of temperature asymmetry, skin color change or asymmetry.
Sudomotor/edema: reports of edema, sweating changes, sweating asymmetry
Motor/trophic: reports of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
Must display at least one sign in two or more of the following categories:
Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
Vasomotor: evidence of temperature asymmetry, color changes, asymmetry
Sudomotor/edema: evidence of edema, sweating changes, sweating asymmetry
Motor/trophic: evidence of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
Exclusion Criteria:
Known COPD > Gold class 1.
History of smoking > 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
Documented substance addiction.
Previous intra-thoracic pleural drainage on affected side.
Previous thoracic surgery on affected side (including sternotomy). - Gross pulmonary or pleural abnormalities on chest X-ray.
Pregnancy, determined by preoperative pregnancy test.
Unsuitable anatomy (e.g. due to severe physical malformations).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo A Mariani, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michiel Kuijpers, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands
12. IPD Sharing Statement
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Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
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