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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Complex Regional Pain Syndrome Type I of the Upper Limb; Unilateral Limb Pain of Other Origin
• Intervention / Treatment: Procedure: Pressure Pain measurement

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44789
      • Bergmannsheil, department for pain management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CRPS; 18 patients with unilateral CPRS of the upper limb were included to the study	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; Other Names: SOMEDIC Production AB, Sweden, Algometer Type II
Patients with limb pain of other origin; 17 patients with unilateral upper limb pain of other origin served as control group	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; Other Names: SOMEDIC Production AB, Sweden, Algometer Type II
Healthy subjects; 18 healthy subjects were included to establish reference data for the pressure pain thresholds	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; Other Names: SOMEDIC Production AB, Sweden, Algometer Type II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2012
• Last Update Submitted That Met QC Criteria: June 18, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: CRPS; Pressure pain thresholds; TPBS; limb pain of other origin
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: Scinti/PressurePain2011