Clinical trial NCT01623141: Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With Complex Regional Pain Syndrome (CRPS)
Official title: Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With CRPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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)
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Decrease of the pressure pain thresholds of the distal hand joints
timeFrame: half an hour
Secondary outcomes:
measure: Increased bone metabolism in the 3 phase bone scintigraphy
timeFrame: 3 hours
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Bergmannsheil, department for pain management
state: Nordrhein-Westfalen
Study officials:
affiliation: Head of the pain clinic of the Bergmannsheil University Hospital
name: Christoph Maier, Prof. Dr.
role: STUDY_DIRECTOR
References: