Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

Phase 4

Completed

• Conditions: CRPS
• Interventions: Drug: Morphine, memantine; Behavioral: Psychological intervention; Other: Physiotherapy intervention

• Registration Number: NCT02467556
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• major psychiatric or neurological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	Morphine, memantine	Open label study with psychological intervention and physiotherapy intervention with medication of morphine, memantine for ten weeks (morphine 30mg tbl per day and memantine up to 40mg tbl per day if tolerated).
intervention	Psychological intervention	Open label study with psychological intervention and physiotherapy intervention with medication of morphine, memantine for ten weeks (morphine 30mg tbl per day and memantine up to 40mg tbl per day if tolerated).
intervention	Physiotherapy intervention	Open label study with psychological intervention and physiotherapy intervention with medication of morphine, memantine for ten weeks (morphine 30mg tbl per day and memantine up to 40mg tbl per day if tolerated).

Primary Outcome Measures

Name	Time	Method
Direction of change in patient reported CRPS symptom discriptors	Three months	Reports of CRPS symptoms

Secondary Outcome Measures

Name	Time	Method
Direction of change in psychological parameters	Three months	Patient scores in BDI, PASS-20, CPAQ
Direction of change in motor parameters	Three months	Measurements of strength of the hand, the active range of motion in the hand/arm, 9HPT, DASH questionnaire
Direction of change in quality of life	Three months	Patient scores in 15D

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland