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NCT Number: NCT01623141

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

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Key information

Conditions

Complex Regional Pain Syndrome Type I of the Upper Limb Autonomic Nervous System Diseases Complex Regional Pain Syndromes Healthy Subjects Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Reflex Sympathetic Dystrophy Unilateral Limb Pain of Other Origin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergmannsheil, department for pain management

Bochum, North Rhine-Westphalia, 44789, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure Pain measurement

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Increased bone metabolism in the 3 phase bone scintigraphy

    Time frame: 3 hours

    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.

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2012
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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