Complex Regional Pain SyndromeNCT02261012
Examination of the Pathophysiologic Mechanisms of CRPS by Using QST, CPM, RIC, and Heart Rate Variability QST
An observational study of Complex Regional Pain Syndrome and Carpal Tunnel Syndrome, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndrome, Carpal Tunnel Syndrome, Neuralgia
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Aug 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects, CRPS-patients, CTS-patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 45Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, 44789
About this study
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
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.
Read the 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.
- Medical subject headings
- Complex Regional Pain Syndromes, Carpal Tunnel Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPM effect
Conditioned Pain Modulation measured by the Heat-Cold-Pain Method
Measured: 60 seconds
Remote Ischemic Conditioning
the perfusion increasing effect after RIC in all groups
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Tina Mainka, Dr. med., Principal investigator, University Hospital Bergmannsheil, Department of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261012
- Sponsor's protocol ID
- CRPS2014
- Status last verified
- Feb 2016
- First submitted
- 6 Oct 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28340289
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
- 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
- ClinicalTrials.gov ID
- NCT02261012
- Acronym / sponsor ID
- CRPS2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Oct 2014 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, CRPS-patients, CTS-patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (45 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Derived from this study: PubMed 28340289Hegelmaier 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.
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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.
Tina Mainka, Dr. med. principal investigator
University Hospital Bergmannsheil, Department of Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndrome and Carpal Tunnel Syndrome, run by Ruhr University of Bochum at 1 site in Germany.
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 6 inclusion and 45 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: finished, 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CPM effect (time frame: 60 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261012, which also lists 1 linked publication.
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.