Clinical Trial: Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Single-port Thoracoscopic Sympathicotomy for Treatment of Complex Regional Pain Syndrome Type I, a Feasibility Study.

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


Detailed Summary:
Sponsor: University of Groningen

Current Primary Outcome: Change in perceived pain measured in Visual Analogue Scale [ Time Frame: Baseline, 1, 3 and 6 months postoperative ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in function in extremity [ Time Frame: Baseline, 1 and 6 months after intervention ]

Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.


Original Secondary Outcome: Same as current

Information By: University of Groningen

Dates:
Date Received: March 24, 2013
Date Started: August 2015
Date Completion: February 2017
Last Updated: February 8, 2016
Last Verified: February 2016