Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
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
Complex Regional Pain Syndrome Type I of the Upper Limb
Procedure: unilateral single-port VATS sympathicotomy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single-port Thoracoscopic Sympathicotomy for Treatment of Complex Regional Pain Syndrome Type I, a Feasibility Study.|
- Change in perceived pain measured in Visual Analogue Scale [ Time Frame: Baseline, 1, 3 and 6 months postoperative ] [ Designated as safety issue: Yes ]
- Change in function in extremity [ Time Frame: Baseline, 1 and 6 months after intervention ] [ Designated as safety issue: No ]Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.
|Study Start Date:||August 2015|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
unilateral single-port VATS sympathicotomy
|Procedure: unilateral single-port VATS sympathicotomy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886625
|University Medical Centre Groningen|
|Groningen, Netherlands, 9700|
|Study Chair:||Massimo A Mariani, MD, PhD||University Medical Center Groningen|
|Principal Investigator:||Michiel Kuijpers, MD||University Medical Center Groningen|