Examination of the Pathophysiologic Mechanisms of CRPS by Using QST, CPM, RIC, and Heart Rate Variability QST
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| ClinicalTrials.gov Identifier: NCT02261012 |
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Recruitment Status :
Completed
First Posted : October 9, 2014
Last Update Posted : February 9, 2016
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| Condition or disease |
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| Complex Regional Pain Syndrome Carpal Tunnel Syndrome Neuralgia |
CRPS is an illness which (seriously) affects patients in their daily life activity. The fact that the pathophysiological mechanisms are not well understood yet makes it hard to treat these patients in the right manner.
Possible patho-mechanisms might be microvascular changes and dysfunctions of the inhibitory descending pain system. Furthermore, recent studies showed that CRPS patients have macrovascular changes and a lower blood level of NO on the affected side. This indicates a NO mediated perfusion dysfunction.
Aim of this study is to examine the pathophysiological mechanism of CRPS in relation to healthy subjects and patients with a different type of pain syndrome (carpal tunnel syndrome) on the upper limb.
The investigators try to get a better understanding of the changes in the pain inhibitory system and micro- and macrocirculating blood-systems, as well as of the autonomic system of CRPS-patients.
| Study Type : | Observational |
| Actual Enrollment : | 62 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Examination of the Pathological Mechanism of the Complex Regional Pain Syndrome of the Upper Limb in Comparison to Patients With Painful Carpal Tunnel Syndrome and Healthy Subjects - an Explorative Clinical Study |
| Study Start Date : | April 2014 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | August 2015 |
| Group/Cohort |
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30 healthy probands
group without the condition of interest
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30 CRPS patients
group with condition of interest
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30 CTS patients
group with a different type of pain on the upper limbs
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- CPM effect [ Time Frame: 60 seconds ]Conditioned Pain Modulation measured by the Heat-Cold-Pain Method
- Remote Ischemic Conditioning [ Time Frame: 45 minutes ]the perfusion increasing effect after RIC in all groups
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
CRPS-patients
Inclusion Criteria:
- Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average pain in the last 4 weeks ≥ 3 in pain Detect)
- Pain history < 1 year
Exclusion criteria:
- Bilateral pain on the upper limbs
- Inadequate knowledge of the german language in speaking and writing
- Acute psychiatric sickness
- Polyneuropathy
- Any added neuropathic sickness on the not affected upper limb sight
- Intolerable pain during the testing
- Injuries within the tested areal
- Acute injuries on the hand
- Pregnancy
- Missing informed consent
CTS-patients
Inclusion Criteria:
- Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average pain in the last 4 weeks ≥ 3 in pain Detect)
- Pain history < 1 year
Exclusion criteria:
- Bilateral pain on the upper limbs
- Inadequate knowledge of the german language in speaking and writing
- Acute psychiatric sickness
- Polyneuropathy
- Any added neuropathic sickness on the not affected upper limb sight
- Intolerable pain during the testing
- Injuries within the tested areal
- Acute injuries on the hand
- Pregnancy
- Missing informed consent
Healthy subjects
Inclusion Criteria:
- Age > 18 years
- Written consent
Exclusion criteria:
- Inadequate knowledge of the german language in speaking and writing
- Current pain
- Pain within in the last 14 days
- Any serious internistic medicin
- Any chronic skin disease
- Any central neural sickness
- Polyneuropathy
- Peripheral nerve lesion within the testing areal
- Any radiculopathy with permanent pain (in the last 3 months)
- Any psychiatric sickness
- Migraine ( at least one attack in the last 24 h)
- Repeating headache (in the last 3 month on >5 days/month)
- Taking any analgesics in the last 14 days
- Taking triptans in the last 24 months
- Taking any psychotropic's in the last 3 months
- Any repeated taking of medication, including amber or different psychostimulants (excluding contraceptives)
- Taking of any prescription and non-prescription drugs (except contraceptives) in the last 7 days or 5 half-life periods(which is always longer) before including into the study
- Achilles reflex absent or within in the side-difference pathologic hypoactive or hyperactive
- pallaesthesia <5/8 (<4/8 at >60 years) on the internal malleolus on both sides
- abuse of alcohol or medications/drugs (corresponding to the DSM IV criteria)
- joining a medical study <30 days before inclusion into the current study
- jet lag, irregular work schedule, sleep deprivation within the last 3 days
- change of intestity during physical activity, e.g. beginning an activity in the last weeks before inclusion into the current study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261012
| Germany | |
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH | |
| Bochum, Nordrhein-Westfalen, Germany, 44789 | |
| Principal Investigator: | Tina Mainka, Dr. med. | University Hospital Bergmannsheil, Department of Pain Medicine |
| Responsible Party: | Christoph Maier, Prof. Dr., Head of the Dep. of Pain Management, Ruhr University of Bochum |
| ClinicalTrials.gov Identifier: | NCT02261012 |
| Other Study ID Numbers: |
CRPS2014 |
| First Posted: | October 9, 2014 Key Record Dates |
| Last Update Posted: | February 9, 2016 |
| Last Verified: | February 2016 |
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Carpal Tunnel Syndrome Neuralgia Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases |
Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Pain Neurologic Manifestations Autonomic Nervous System Diseases |