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Examination of the Pathophysiologic Mechanisms of CRPS by Using QST, CPM, RIC, and Heart Rate Variability QST

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Completed
CT.gov ID
NCT02261012
Collaborator
(none)
62
Enrollment
1
Location
16
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Apr 1, 2014
    Actual Primary Completion Date :
    Apr 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. CPM effect [60 seconds]

      Conditioned Pain Modulation measured by the Heat-Cold-Pain Method

    2. Remote Ischemic Conditioning [45 minutes]

      the perfusion increasing effect after RIC in all groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 9, 2014
    Last Update Posted:
    Feb 9, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Neuralgia
    Complex Regional Pain Syndromes
    Reflex Sympathetic Dystrophy
    Syndrome

    Study Results

    No Results Posted as of Feb 9, 2016