CRPS Type I of the Upper ExtremityNCT01888783
Two Measures of Tactile Acuity in CRPS Type I Patients
A study testing Tactile acuity measured by 2PD and the GOT in people with CRPS Type I of the Upper Extremity and Neuropathy of the Median Nerve, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRPS Type I of the Upper Extremity, Neuropathy of the Median Nerve, Healthy Controls
- What is being tested?
- Tactile acuity measured by 2PD and the GOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 2013
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
- Patients diagnosed with a neuropathy of the median nerve
- Healthy Controls,matched in age and gender to both patient cohorts
Who cannot join
- intolerable hyperalgesia
- lesions at the fingertips
- high grade digit contracture
- central neurologic disorders
- psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, 44789
Christoph Maier, Prof. Dr., +49 2343023402, Christoph.Maier@rub.de
Marianne David, Dr., +49 2343023324, Marianne.David@rub.de
About this study
Official title: Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
- Being tested
- Tactile acuity measured by 2PD and the GOT
- Keywords
- CRPS Type I, tactile acuity, 2-point-discrimination, Grating Orientation Task, sensory signs
- Medical subject headings
- Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile acuity measured by 2PD and the GOTOther
Also called 2-point-discrimination (2PD), Grating Orientation Task (GOT)
For a detailed description of the methods see "outcome measures"
| Study group | Role | What they receive |
|---|---|---|
| CRPS Type I | Experimental | Patients diagnosed with complex regional pain syndrome type I of the upper limb Receives: Other: Tactile acuity measured by 2PD and the GOT |
| Median Nerve Neuropathy | Active comparator | Patients diagnosed with a neuropathy of the median nerve of the upper limb. Receives: Other: Tactile acuity measured by 2PD and the GOT |
| Healthy Controls | Active comparator | Healthy adult persons. Receives: Other: Tactile acuity measured by 2PD and the GOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
tactile acuity as measured by 2-point-discrimination
Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given
Measured: unique measurement of maximal one hour duration
tactile acuity as measured by the Grating Orientation Task (GOT)
Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used
Measured: unique measurement of maximal half an hour duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPS Type I of the Upper ExtremityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- Christoph Maier, Prof. Dr., Study chair, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888783
- Sponsor's protocol ID
- GOT_CRPS2013
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
- ClinicalTrials.gov ID
- NCT01888783
- Acronym / sponsor ID
- GOT_CRPS2013
- Keywords
- CRPS Type I, tactile acuity, 2-point-discrimination, Grating Orientation Task, sensory signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 28 Jun 2013 (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 to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRPS Type I | Experimental | Other: Tactile acuity measured by 2PD and the GOTPatients diagnosed with complex regional pain syndrome type I of the upper limb |
| Median Nerve Neuropathy | Active comparator | Other: Tactile acuity measured by 2PD and the GOTPatients diagnosed with a neuropathy of the median nerve of the upper limb. |
| Healthy Controls | Active comparator | Other: Tactile acuity measured by 2PD and the GOTHealthy adult persons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
- Patients diagnosed with a neuropathy of the median nerve
- Healthy Controls,matched in age and gender to both patient cohorts
Key exclusion criteria (5 listed)
- intolerable hyperalgesia
- lesions at the fingertips
- high grade digit contracture
- central neurologic disorders
- psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile acuity measured by 2PD and the GOTAlso: 2-point-discrimination (2PD), Grating Orientation Task (GOT)For a detailed description of the methods see "outcome measures" | Other | CRPS Type I, Healthy Controls, Median Nerve Neuropathy |
Primary outcome
tactile acuity as measured by 2-point-discrimination
Time frame: unique measurement of maximal one hour duration
Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given
tactile acuity as measured by the Grating Orientation Task (GOT)
Time frame: unique measurement of maximal half an hour duration
Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Related trials for CRPS Type I of the Upper Extremity
Recruiting
The Effects of Whirlpool and Contrast Bath in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture
Distal Radius Fracture, Complex Regional Pain Syndrome Type I
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.
Christoph Maier, Prof. Dr. study chair
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile acuity measured by 2PD and the GOT in people with CRPS Type I of the Upper Extremity and Neuropathy of the Median Nerve, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Maier, Prof. Dr. (+49 2343023402, Christoph.Maier@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tactile acuity as measured by 2-point-discrimination (time frame: unique measurement of maximal one hour duration). 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?
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 2 Aug 2013.