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

Complex Regional Pain Syndrome Type I of the Upper Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01886625
• Other study ID #: NL41466.042.12
• Status: Withdrawn
• Phase: N/A
• First received: March 24, 2013
• Last updated: February 8, 2016
• Start date: August 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2016
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I of the Upper Limb
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• unilateral single-port VATS sympathicotomy

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived pain measured in Visual Analogue Scale		Baseline, 1, 3 and 6 months postoperative	Yes
Secondary	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	No