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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb
• Intervention / Treatment: Procedure: unilateral single-port VATS sympathicotomy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700
    • University Medical Centre Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sympathicotomy; unilateral single-port VATS sympathicotomy	Procedure: unilateral single-port VATS sympathicotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in perceived pain measured in Visual Analogue Scale	Baseline, 1, 3 and 6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in function in extremity	Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.	Baseline, 1 and 6 months after intervention

Collaborators and Investigators

• Sponsor: University of Groningen
• Investigators: Principal Investigator: Michiel Kuijpers, MD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: March 24, 2013
• First Submitted That Met QC Criteria: June 23, 2013
• First Posted (Estimate): June 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: NL41466.042.12