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

NCT ID: NCT02261012

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-08-31

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.

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.

Conditions

Complex Regional Pain Syndrome; Carpal Tunnel Syndrome; Neuralgia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

30 healthy probands

group without the condition of interest

No interventions assigned to this group

30 CRPS patients

group with condition of interest

No interventions assigned to this group

30 CTS patients

group with a different type of pain on the upper limbs

No interventions assigned to this group

Eligibility Criteria

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

• 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

• Age > 18 years
• Written consent

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Christoph Maier, Prof. Dr.

Head of the Dep. of Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tina Mainka, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bergmannsheil, Department of Pain Medicine

Locations

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

References

Hegelmaier T, Kumowski N, Mainka T, Vollert J, Goertz O, Lehnhardt M, Zahn PK, Maier C, Kolbenschlag J. Remote ischaemic conditioning decreases blood flow and improves oxygen extraction in patients with early complex regional pain syndrome. Eur J Pain. 2017 Sep;21(8):1346-1354. doi: 10.1002/ejp.1033. Epub 2017 Mar 24.

Reference Type: DERIVED

PMID: 28340289 (View on PubMed)

Other Identifiers

CRPS2014

Identifier Type: -

Identifier Source: org_study_id