Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

NCT ID: NCT02467556

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

CRPS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Morphine, memantine

Intervention Type: DRUG

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

Psychological intervention

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Morphine, memantine

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

Intervention Type: DRUG

Psychological intervention

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.

Intervention Type: BEHAVIORAL

Physiotherapy intervention

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

Intervention Type: OTHER

Other Intervention Names

Depolan (morphine), Ebixa (memantine)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• major psychiatric or neurological disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanna Harno

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eija Kalso, MD, PhD

Role: STUDY_DIRECTOR

Professor

Locations

Helsinki University Central Hospital

Helsinki, HUS, Finland

Countries

Finland

References

Bean DJ, Johnson MH, Kydd RR. The outcome of complex regional pain syndrome type 1: a systematic review. J Pain. 2014 Jul;15(7):677-90. doi: 10.1016/j.jpain.2014.01.500. Epub 2014 Feb 12.

Reference Type: BACKGROUND

PMID: 24530407 (View on PubMed)

Gustin SM, Schwarz A, Birbaumer N, Sines N, Schmidt AC, Veit R, Larbig W, Flor H, Lotze M. NMDA-receptor antagonist and morphine decrease CRPS-pain and cerebral pain representation. Pain. 2010 Oct;151(1):69-76. doi: 10.1016/j.pain.2010.06.022. Epub 2010 Jul 13.

Reference Type: BACKGROUND

PMID: 20630656 (View on PubMed)

Elomaa M, Hotta J, de C Williams AC, Forss N, Ayrapaa A, Kalso E, Harno H. Symptom reduction and improved function in chronic CRPS type 1 after 12-week integrated, interdisciplinary therapy. Scand J Pain. 2019 Apr 24;19(2):257-270. doi: 10.1515/sjpain-2018-0098.

Reference Type: DERIVED

PMID: 30789827 (View on PubMed)

Other Identifiers

Helsinki University Hospital

Identifier Type: -

Identifier Source: org_study_id