Trial record 10 of 59 for:    Open Studies | "Complex Regional Pain Syndromes"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Groningen
Sponsor:
Information provided by (Responsible Party):
Michiel Kuijpers, University of Groningen
ClinicalTrials.gov Identifier:
NCT01886625
First received: March 24, 2013
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

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 Intervention
Complex Regional Pain Syndrome Type I of the Upper Limb
Procedure: unilateral single-port VATS sympathicotomy

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Groningen:

Primary Outcome Measures:
  • Change in perceived pain measured in Visual Analogue Scale [ Time Frame: Baseline, 1, 3 and 6 months postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sympathicotomy
unilateral single-port VATS sympathicotomy
Procedure: unilateral single-port VATS sympathicotomy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886625

Contacts
Contact: Michiel Kuijpers, MD +31503613238 m.kuijpers@umcg.nl

Locations
Netherlands
University Medical Centre Groningen Not yet recruiting
Groningen, Netherlands, 9700
Sponsors and Collaborators
University of Groningen
Investigators
Study Chair: Massimo A Mariani, MD, PhD University Medical Centre Groningen
Principal Investigator: Michiel Kuijpers, MD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Michiel Kuijpers, Principal Investigator, University of Groningen
ClinicalTrials.gov Identifier: NCT01886625     History of Changes
Other Study ID Numbers: NL41466.042.12
Study First Received: March 24, 2013
Last Updated: June 23, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 18, 2014