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Trial record 47 of 130 for:    Complex Regional Pain Syndrome

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
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum

Brief Summary:
This study aims for a better understanding of the pathophysiological mechanisms of the complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the analysis of the heart-rate variability in patients with CRPS and a control-group. We hypothesize decreased conditioned pain modulation, less effects of remote ischemic conditioning and an affection of the heart-rate variability in patients with CPRS.

Condition or disease
Complex Regional Pain Syndrome Carpal Tunnel Syndrome Neuralgia

Detailed Description:

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
30 healthy probands
group without the condition of interest
30 CRPS patients
group with condition of interest
30 CTS patients
group with a different type of pain on the upper limbs



Primary Outcome Measures :
  1. CPM effect [ Time Frame: 60 seconds ]
    Conditioned Pain Modulation measured by the Heat-Cold-Pain Method

  2. 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
Study Population
Healthy subjects, CRPS-patients, CTS-patients
Criteria

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

Information from the National Library of Medicine

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


Locations
Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, Nordrhein-Westfalen, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Tina Mainka, Dr. med. University Hospital Bergmannsheil, Department of Pain Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Maier, Prof. Dr., Head of the Dep. of Pain Management, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02261012     History of Changes
Other Study ID Numbers: CRPS2014
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Nerve Compression Syndromes
Neuralgia
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Median Neuropathy
Mononeuropathies
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Autonomic Nervous System Diseases