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

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ClinicalTrials.gov Identifier: NCT01886625
Recruitment Status : Withdrawn (No local inclusions)
First Posted : June 26, 2013
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Michiel Kuijpers, University of Groningen

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


Condition or disease Intervention/treatment
Complex Regional Pain Syndrome Type I of the Upper Limb Procedure: unilateral single-port VATS sympathicotomy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-port Thoracoscopic Sympathicotomy for Treatment of Complex Regional Pain Syndrome Type I, a Feasibility Study.
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sympathicotomy
unilateral single-port VATS sympathicotomy
Procedure: unilateral single-port VATS sympathicotomy



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

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    1. Continuing pain which is disproportionate to any inciting event
    2. 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)
    3. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886625


Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700
Sponsors and Collaborators
University of Groningen
Investigators
Study Chair: Massimo A Mariani, MD, PhD University Medical Center Groningen
Principal Investigator: Michiel Kuijpers, MD University Medical Center Groningen

Responsible Party: Michiel Kuijpers, Principal Investigator, University of Groningen
ClinicalTrials.gov Identifier: NCT01886625     History of Changes
Other Study ID Numbers: NL41466.042.12
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases