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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01623141
First received: June 15, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Complex Regional Pain Syndrome Type I of the Upper Limb
Unilateral Limb Pain of Other Origin
Healthy Subjects
Procedure: Pressure Pain measurement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With CRPS

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Decrease of the pressure pain thresholds of the distal hand joints [ Time Frame: half an hour ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Increased bone metabolism in the 3 phase bone scintigraphy [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: SOMEDIC Production AB, Sweden, Algometer Type II

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01623141

Locations
Germany
Bergmannsheil, department for pain management
Bochum, Nordrhein-Westfalen, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Study Director: Christoph Maier, Prof. Dr. Head of the pain clinic of the Bergmannsheil University Hospital
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr. med. (Head of the pain clinic of the Bergmannsheil University Hospital), Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01623141     History of Changes
Other Study ID Numbers: Scinti/PressurePain2011
Study First Received: June 15, 2012
Last Updated: June 18, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
CRPS
TPBS
Pressure pain thresholds
limb pain of other origin

Additional relevant MeSH terms:
Reflex Sympathetic Dystrophy
Somatoform Disorders
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014