- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02467556
Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome (MultiModCRPS)
March 20, 2020 updated by: Hanna Harno, Helsinki University Central Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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HUS
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Helsinki, HUS, Finland, 00029
- Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- CRPS type 1 for at least 6 months,
- pain NRS 4 or more
Exclusion Criteria:
- major psychiatric or neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
|
Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.
Other Names:
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.
Graded motor imagenary with group and individual weekly sessions with daily practices at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direction of change in patient reported CRPS symptom discriptors
Time Frame: Three months
|
Reports of CRPS symptoms
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Three months
|
Direction of change in psychological parameters
Time Frame: Three months
|
Patient scores in BDI, PASS-20, CPAQ
|
Three months
|
Direction of change in quality of life
Time Frame: Three months
|
Patient scores in 15D
|
Three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Eija Kalso, MD, PhD, professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 8, 2015
First Submitted That Met QC Criteria
June 9, 2015
First Posted (Estimate)
June 10, 2015
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 20, 2020
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Morphine
- Memantine
Other Study ID Numbers
- Helsinki University Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to make IPD available.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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