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Completed

NCT Number: NCT02467556

Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

A ten week open label study intervention to evaluate the outcome for a psychological intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS patients.

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Key information

Conditions

CRPS

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

About this study

Ten CRPS I patients attended an intervention for 10 weeks. First, the medication was started with morphine 10mg adding gradually to 30 mg per day. Then, in addition to morphine, memantine 5 mg was started adding the dose gradually up to 40 mg per day if tolerated. Physiotherapy and psychological intervention were mostly carried out in a weekly group gathering with home exercises that were recorded to a diary. Psychological and physiotherapy interventions lasted for eight weeks. A neurological examination was done before and after the intervention as well as a separate physiotherapist examination of the hands. Patients filled out questionnaires of mood, quality of life, pain, and CRPS descriptions before and after the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CRPS type 1 for at least 6 months,
  • pain NRS 4 or more

Exclusion criteria

  • major psychiatric or neurological disease

Treatment and study plan

Morphine, memantine

Drug

Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.

Other names: Depolan (morphine), Ebixa (memantine)

Psychological intervention

Behavioral

To help patients shift perspective from pain and CRPS-symptoms, to increase body awareness, to create vivid imagenary, to increase the use of a CRPS hand with mindfulness exposure exercises, to increase flexibility in behavioral repertoire, to explore the fusion of emotions, automatic cognitions and learned responses and to help patients to integrate new skills in their lives.

physiotherapy intervention

Other

Graded motor imagenary with group and individual weekly sessions with daily practices at home.

Primary outcomes

  1. Direction of change in patient reported CRPS symptom discriptors

    Time frame: Three months

    Reports of CRPS symptoms

Secondary outcomes

  1. Direction of change in motor parameters

    Time frame: Three months

    Measurements of strength of the hand, the active range of motion in the hand/arm, 9HPT, DASH questionnaire

  2. Direction of change in psychological parameters

    Time frame: Three months

    Patient scores in BDI, PASS-20, CPAQ

  3. Direction of change in quality of life

    Time frame: Three months

    Patient scores in 15D

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: MultiModCRPS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2015
Registry last updated
Mar 24, 2020

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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