CRPSPhase 4MultiModCRPSNCT02467556
Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome
A Phase 4 study testing Morphine, memantine, Psychological intervention and Physiotherapy intervention in people with CRPS, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- CRPS
- What is being tested?
- Morphine, memantine, Psychological intervention and Physiotherapy intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2011to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRPS type 1 for at least 6 months,
- pain NRS 4 or more
Who cannot join
- major psychiatric or neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Morphine, memantine, Psychological intervention, Physiotherapy intervention
- Keywords
- CRPS, intervention, multimodal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine, memantineDrug
Also called Depolan (morphine), Ebixa (memantine)
Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.
Psychological interventionBehavioural
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 interventionOther
Graded motor imagenary with group and individual weekly sessions with daily practices at home.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | 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). Receives: Drug: Morphine, memantine; Behavioral: Psychological intervention; Other: Physiotherapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direction of change in patient reported CRPS symptom discriptors
Reports of CRPS symptoms
Measured: Three months
Secondary outcomes (3)
Direction of change in motor parameters
Measurements of strength of the hand, the active range of motion in the hand/arm, 9HPT, DASH questionnaire
Measured: Three months
Direction of change in psychological parameters
Patient scores in BDI, PASS-20, CPAQ
Measured: Three months
Direction of change in quality of life
Patient scores in 15D
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CRPSStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Harno, Helsinki University Central Hospital
- Investigators
- Eija Kalso, MD, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467556
- Sponsor's protocol ID
- Helsinki University Hospital
- Acronym
- MultiModCRPS
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make IPD available.
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.
PubMed 24530407Gustin 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.
PubMed 20630656Elomaa 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.
PubMed 30789827
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome
- ClinicalTrials.gov ID
- NCT02467556
- Acronym / sponsor ID
- MultiModCRPS / Helsinki University Hospital
- Conditions
- CRPS
- Keywords
- CRPS, intervention, multimodal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Drug: Morphine, memantine, Behavioral: Psychological intervention, Other: Physiotherapy interventionOpen 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CRPS type 1 for at least 6 months,
- pain NRS 4 or more
Key exclusion criteria (1 listed)
- major psychiatric or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine, memantineAlso: Depolan (morphine), Ebixa (memantine)Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks. | Drug | intervention |
| Psychological interventionTo 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. | Behavioural | intervention |
| Physiotherapy interventionGraded motor imagenary with group and individual weekly sessions with daily practices at home. | Other | intervention |
Primary outcome
Direction of change in patient reported CRPS symptom discriptors
Time frame: Three months
Reports of CRPS symptoms
3 secondary outcomes
Direction of change in motor parameters
Time frame: Three months
Direction of change in psychological parameters
Time frame: Three months
Direction of change in quality of life
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 24530407Bean 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.
- Background: PubMed 20630656Gustin 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.
- Derived from this study: PubMed 30789827Elomaa 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
Related trials for CRPS
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Recruiting
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CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Kalso, MD, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine, memantine, Psychological intervention and Physiotherapy intervention in people with CRPS, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direction of change in patient reported CRPS symptom discriptors (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467556, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.