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

NCT ID: NCT01886625

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-02-28

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

Conditions

Complex Regional Pain Syndrome Type I of the Upper Limb

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sympathicotomy

unilateral single-port VATS sympathicotomy

Group Type: EXPERIMENTAL

unilateral single-port VATS sympathicotomy

Intervention Type: PROCEDURE

Interventions

unilateral single-port VATS sympathicotomy

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Groningen

OTHER

Sponsor Role: lead

Responsible Party

Michiel Kuijpers

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo A Mariani, MD, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

Michiel Kuijpers, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

NL41466.042.12

Identifier Type: -

Identifier Source: org_study_id