Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

CRPS Clinical Trial

— MultiModCRPS  

Official title:

Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467556
• Other study ID #: Helsinki University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• CRPS type 1 for at least 6 months,

• pain NRS 4 or more

Exclusion Criteria:

• major psychiatric or neurological disease

Related Conditions & MeSH terms

• CRPS

Intervention

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

Behavioral:
• 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.

Other:
• Physiotherapy intervention
Graded motor imagenary with group and individual weekly sessions with daily practices at home.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direction of change in patient reported CRPS symptom discriptors	Reports of CRPS symptoms	Three months
Secondary	Direction of change in motor parameters	Measurements of strength of the hand, the active range of motion in the hand/arm, 9HPT, DASH questionnaire	Three months
Secondary	Direction of change in psychological parameters	Patient scores in BDI, PASS-20, CPAQ	Three months
Secondary	Direction of change in quality of life	Patient scores in 15D	Three months