Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With Complex Regional Pain Syndrome (CRPS)

Healthy Subjects Clinical Trial

Official title:

Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With CRPS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623141
• Other study ID #: Scinti/PressurePain2011
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: June 18, 2012
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I of the Upper Limb
• Complex Regional Pain Syndromes
• Healthy Subjects
• Reflex Sympathetic Dystrophy
• Unilateral Limb Pain of Other Origin

Intervention

Procedure:
• Pressure Pain measurement
The pressure pain thresholds were established using a manual pressure algometer. The investigated joints were the carpus, the metacarpophalangeal and the proximal interphalangeal joints

Locations

Country	Name	City	State
Germany	Bergmannsheil, department for pain management	Bochum	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	half an hour	No
Secondary	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.	3 hours	No