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

NCT01886625 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-02-09

No results posted yet for this study

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

Conditions

  • Complex Regional Pain Syndrome Type I of the Upper Limb

Interventions

PROCEDURE

unilateral single-port VATS sympathicotomy

Sponsors & Collaborators

  • University of Groningen

    lead OTHER

Principal Investigators

  • Massimo A Mariani, MD, PhD · University Medical Center Groningen

  • Michiel Kuijpers, MD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886625 on ClinicalTrials.gov