Algodystrophy of HandProHKM-SDRCNCT03260361
Hypnosis and MEOPA in Regional Painful Syndrome Complex
A study testing Hypnosis, kinesitherapy, MEOPA and Usual practice in people with Algodystrophy of Hand, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Relation between hypnosis and MEOPA on algodystrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Algodystrophy of Hand
- What is being tested?
- Hypnosis, kinesitherapy, MEOPA and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Sep 2017to 7 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regional Painful Syndrome Complex
Who cannot join
- deaf people
Trial locations and contacts
2 sites in 1 country.
France2 sites
Croix du Sud
Quint-Fonsegrives, 31130
University Hospital of Toulouse
Toulouse, 31059
About this study
Official title: Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex
Relation between hypnosis and MEOPA on algodystrophy.
- Conditions
- Algodystrophy of Hand
- Being tested
- Hypnosis, kinesitherapy, MEOPA, Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis, kinesitherapy, MEOPAOther
Also called Hypnosis Kinesitherapy and MEOPA (HKM)
classical intervention
Usual practiceOther
Usual practice with treatments and physio
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Kinesitherapy and MEOPA | Experimental | combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM) Receives: Other: Hypnosis, kinesitherapy, MEOPA |
| usual practice | Other | physiopathology and treatments Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measure using visual analogical ladder (EVA)
pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
Measured: 3 weeks
Secondary outcomes (3)
QDSA ( Saint Antoine Pain Questions)
description of the type of pain
Measured: 3 weeks
SF36 (Short Form (36) Health Survey)
quality of life appreciation
Measured: 3 weeks
HADs
Hospital Anxiety and Depression Scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start6 Sep 2017
- Primary completion7 Nov 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Algodystrophy of HandStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine QUINTARD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260361
- Sponsor's protocol ID
- RC31/16/8235
- Acronym
- ProHKM-SDRC
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.
PubMed 10524476
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex
- ClinicalTrials.gov ID
- NCT03260361
- Acronym / sponsor ID
- ProHKM-SDRC / RC31/16/8235
- Conditions
- Algodystrophy of Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 24 Aug 2017 (actual)
- 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.
Relation between hypnosis and MEOPA on algodystrophy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Kinesitherapy and MEOPA | Experimental | Other: Hypnosis, kinesitherapy, MEOPAcombined therapy of Hypnosis Kinesitherapy and MEOPA (HKM) |
| usual practice | Other | Other: Usual practicephysiopathology and treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Regional Painful Syndrome Complex
Key exclusion criteria (1 listed)
- deaf people
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 |
|---|---|---|
| Hypnosis, kinesitherapy, MEOPAAlso: Hypnosis Kinesitherapy and MEOPA (HKM)classical intervention | Other | Hypnosis Kinesitherapy and MEOPA |
| Usual practiceUsual practice with treatments and physio | Other | usual practice |
Primary outcome
Pain intensity measure using visual analogical ladder (EVA)
Time frame: 3 weeks
pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
3 secondary outcomes
QDSA ( Saint Antoine Pain Questions)
Time frame: 3 weeks
SF36 (Short Form (36) Health Survey)
Time frame: 3 weeks
HADs
Time frame: 3 weeks
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 23 Aug 2023.
- Background: PubMed 10524476Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.
- Individual participant dataSharing planned: No
Related trials for Algodystrophy of Hand
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.
Martine QUINTARD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis, kinesitherapy, MEOPA and Usual practice in people with Algodystrophy of Hand, run by University Hospital, Toulouse at 2 sites in France.
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 1 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
Pain intensity measure using visual analogical ladder (EVA) (time frame: 3 weeks). 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 NCT03260361, which also lists 1 linked publication.
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 23 Aug 2023.