Complex Regional Pain Syndrome Type I of the Upper LimbNCT01623141
Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With Complex Regional Pain Syndrome (CRPS)
An observational study of Complex Regional Pain Syndrome Type I of the Upper Limb and Unilateral Limb Pain of Other Origin, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The aim of the study is to investigate the correlation between increased bone metabolism in the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. 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 Type I of the Upper Limb, Unilateral Limb Pain of Other Origin, Healthy Subjects
- What is being tested?
- Pressure Pain measurement
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Oct 2011
- 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: The study sample consists of three groups: 1. Patients with CRPS of one of the upper limb type 1 (n=18) 2. Patients with unilateral upper limb pain of other origin (n=17) 3. Healthy subjects (n=18) All patients were recruited from the Department of Pain medicine and the Department of nuclear medicine of the University Hospital Bergmannsheil
Who may be able to join
- every participant:
- aged > 18 years with written informed consent
- adequate understanding of the german language
- indication for a TPBS independent of the study
- Patients with CRPS:
- patients with CRPS type 1 of the upper limb diagnosed on the basis of the budapest criteria (Harden, Bruehl et al., 2010)
Show all 12Show fewer
- unilateral pain
- Control group:
- patients with pain of the upper limbs of other origin than CRPS who underwent a TPBS
- unilateral pain
- Healthy subjects:
- checked by the DFNS IMI questionnaire
Who cannot join
- missing informed consent
- inadequate understanding of the german language
- disease duration of more than 12 months
- other disease of the upper extremity (e.g. polyarthrosis, rheumatoid arthritis)
- pregnancy/ lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bergmannsheil, department for pain management
Bochum, North Rhine-Westphalia, 44789
About this study
Official title: Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With CRPS
The aim of the study is to investigate the correlation between increased bone metabolism in the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The investigators assume that there will be a significant correlation between the investigated values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.
Read the detailed description
Pressure pain of the distal hand joints is a predominant symptom of CRPS. But so far, the diagnostic value of pressure pain in the diagnosis of CRPS has not been investigated. We compared the pressure pain thresholds of the carpus, metacarpophalangeal and proximal interphalangeal joints to a region of interest-based (ROI) analysis of a TBPS in patients with CRPS and patients with limb pain of other origin (non-CRPS-group).Additionally, the PPTs were established for a healthy control group to get reference data.
- Conditions
- Complex Regional Pain Syndrome Type I of the Upper Limb, Unilateral Limb Pain of Other Origin, Healthy Subjects
- Being tested
- Pressure Pain measurement
- Keywords
- CRPS, TPBS, Pressure pain thresholds, limb pain of other origin
- 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.
Pressure Pain measurementProcedure or surgery
Also called SOMEDIC Production AB, Sweden, Algometer Type II
The pressure pain thresholds were established using a manual pressure algometer. The investigated joints were the carpus, the metacarpophalangeal and the proximal interphalangeal joints
| Study group | Role | What they receive |
|---|---|---|
| Patients with CRPS | 18 patients with unilateral CPRS of the upper limb were included to the study Receives: Procedure: Pressure Pain measurement | |
| Patients with limb pain of other origin | 17 patients with unilateral upper limb pain of other origin served as control group Receives: Procedure: Pressure Pain measurement | |
| Healthy subjects | 18 healthy subjects were included to establish reference data for the pressure pain thresholds Receives: Procedure: Pressure Pain measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the pressure pain thresholds of the distal hand joints
The pressure pain thresholds (PPT) were mesured for the carpus, metacarpophalangeal and proximal interphalangeal joints of both hands. The mean of three determined measurements of each joint was taken as the final value. Subseqently the PPT were compared to the results of the 3 phase bone scintigraphy and the reference data of the healthy subjects.
Measured: half an hour
Secondary outcomes (1)
Increased bone metabolism in the 3 phase bone scintigraphy
All Patients with CRPS and limb pain of other origin underwented a 3 phase bone scitigraphy to investigate a possible increased bone metabolism. Phase one and two were recorded within the first five minutes after injection of approximately 500-700 MBq 99mTechnetium-labeled methylene diphosphonate. The third phase was obtained two to three hours after injection.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type I of the Upper LimbStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr., Study director, Head of the pain clinic of the Bergmannsheil University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623141
- Sponsor's protocol ID
- Scinti/PressurePain2011
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With CRPS
- ClinicalTrials.gov ID
- NCT01623141
- Acronym / sponsor ID
- Scinti/PressurePain2011
- Conditions
- Complex Regional Pain Syndrome Type I of the Upper Limb, Unilateral Limb Pain of Other Origin, Healthy Subjects
- Keywords
- CRPS, TPBS, Pressure pain thresholds, limb pain of other origin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Jun 2012 (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.
The aim of the study is to investigate the correlation between increased bone metabolism in the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The investigators assume that there will be a significant correlation between the investigated values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.
Detailed description
Pressure pain of the distal hand joints is a predominant symptom of CRPS. But so far, the diagnostic value of pressure pain in the diagnosis of CRPS has not been investigated. We compared the pressure pain thresholds of the carpus, metacarpophalangeal and proximal interphalangeal joints to a region of interest-based (ROI) analysis of a TBPS in patients with CRPS and patients with limb pain of other origin (non-CRPS-group).Additionally, the PPTs were established for a healthy control group to get reference data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPS | – | Procedure: Pressure Pain measurement18 patients with unilateral CPRS of the upper limb were included to the study |
| Patients with limb pain of other origin | – | Procedure: Pressure Pain measurement17 patients with unilateral upper limb pain of other origin served as control group |
| Healthy subjects | – | Procedure: Pressure Pain measurement18 healthy subjects were included to establish reference data for the pressure pain thresholds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample consists of three groups: 1. Patients with CRPS of one of the upper limb type 1 (n=18) 2. Patients with unilateral upper limb pain of other origin (n=17) 3. Healthy subjects (n=18) All patients were recruited from the Department of Pain medicine and the Department of nuclear medicine of the University Hospital Bergmannsheil
Key inclusion criteria (12 listed)
- aged > 18 years with written informed consent
- adequate understanding of the german language
- indication for a TPBS independent of the study
- patients with CRPS type 1 of the upper limb diagnosed on the basis of the budapest criteria (Harden, Bruehl et al., 2010)
- unilateral pain
Key exclusion criteria (5 listed)
- missing informed consent
- inadequate understanding of the german language
- disease duration of more than 12 months
- other disease of the upper extremity (e.g. polyarthrosis, rheumatoid arthritis)
- pregnancy/ lactation period
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 |
|---|---|---|
| Pressure Pain measurementAlso: SOMEDIC Production AB, Sweden, Algometer Type IIThe pressure pain thresholds were established using a manual pressure algometer. The investigated joints were the carpus, the metacarpophalangeal and the proximal interphalangeal joints | Procedure or surgery | Healthy subjects, Patients with CRPS, Patients with limb pain of other origin |
Primary outcome
Decrease of the pressure pain thresholds of the distal hand joints
Time frame: half an hour
The pressure pain thresholds (PPT) were mesured for the carpus, metacarpophalangeal and proximal interphalangeal joints of both hands. The mean of three determined measurements of each joint was taken as the final value. Subseqently the PPT were compared to the results of the 3 phase bone scintigraphy and the reference data of the healthy subjects.
1 secondary outcome
Increased bone metabolism in the 3 phase bone scintigraphy
Time frame: 3 hours
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 19 Jun 2012.
Related trials for Complex Regional Pain Syndrome Type I of the Upper Limb
Recruiting
Effects of Task-Based Mirror Therapy for Post-stroke Shoulder-Hand Syndrome
Stroke
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 director
Head of the pain clinic of the Bergmannsheil University Hospital
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 Type I of the Upper Limb and Unilateral Limb Pain of Other Origin, 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 12 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: finished, as of the sponsor's last update on 19 Jun 2012. 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?
Decrease of the pressure pain thresholds of the distal hand joints (time frame: half an hour). 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 19 Jun 2012.