Complex Regional Pain Syndrome Type I of the Upper LimbNCT01886625
Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
A study testing unilateral single-port VATS sympathicotomy in people with Complex Regional Pain Syndrome Type I of the Upper Limb, run by University of Groningen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I of the Upper Limb
- What is being tested?
- unilateral single-port VATS sympathicotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years.
- ASA 1 en 2.
- CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.
- Continuing pain which is disproportionate to any inciting event
- Must report at least one symptom in each of the four following categories
- Sensory: reports of hyperesthesia
Show all 14Show fewer
- 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)
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700
About this study
Official title: 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
- Being tested
- unilateral single-port VATS sympathicotomy
- Medical subject headings
- Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral single-port VATS sympathicotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sympathicotomy | Experimental | unilateral single-port VATS sympathicotomy Receives: Procedure: unilateral single-port VATS sympathicotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived pain measured in Visual Analogue Scale
Measured: Baseline, 1, 3 and 6 months postoperative
Secondary outcomes (1)
Change in function in extremity
Strength in fingers, maximal flexion/extension in all digits, volumetric measurement, timing simple daily tasks.
Measured: Baseline, 1 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: No local inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type I of the Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel Kuijpers, University of Groningen
- Investigators
- Massimo A Mariani, MD, PhD, Study chair, University Medical Center GroningenMichiel Kuijpers, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886625
- Sponsor's protocol ID
- NL41466.042.12
- Status last verified
- Feb 2016
- First submitted
- 24 Mar 2013
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-port Thoracoscopic Sympathicotomy for Treatment of Complex Regional Pain Syndrome Type I, a Feasibility Study.
- ClinicalTrials.gov ID
- NCT01886625
- Acronym / sponsor ID
- NL41466.042.12
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No local inclusions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sympathicotomy | Experimental | Procedure: unilateral single-port VATS sympathicotomyunilateral single-port VATS sympathicotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 - 65 years.
- ASA 1 en 2.
- CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unilateral single-port VATS sympathicotomy | Procedure or surgery | Sympathicotomy |
Primary outcome
Change in perceived pain measured in Visual Analogue Scale
Time frame: Baseline, 1, 3 and 6 months postoperative
1 secondary outcome
Change in function in extremity
Time frame: Baseline, 1 and 6 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo A Mariani, MD, PhD study chair
University Medical Center Groningen
Michiel Kuijpers, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral single-port VATS sympathicotomy in people with Complex Regional Pain Syndrome Type I of the Upper Limb, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived pain measured in Visual Analogue Scale (time frame: Baseline, 1, 3 and 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.