AllodyniaRESISTALNCT02571010

Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia

A study testing Standard Medical treatment and Vibrotactile stimulation in people with Allodynia, run by CRRF La Châtaigneraie at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allodynia
What is being tested?: Standard Medical treatment and Vibrotactile stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteFrance
Study dates: Oct 2015to 2 May 2019
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

None listed.

Who cannot join

Patient with neuralgia (spontaneous pain) with or without allodynia;
Patient not able to participate actively to the rehabilitation exercises for physical reason, cognitive reason (ability to understand instructions) or behavioural reason (e.g. addiction...);
Patient with complex regional pain syndrome (type I);
Patients for whom cares cannot avoid any touch with allodynia area;
Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
Prior treatment by somatosensory rehabilitation;

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Duration of stay in the medical center < 11 weeks;
Patient with cognitive disorder;
Allodynia area of the patient presenting with conditions not recommended for vibrotactile stimulation: wound, unhealed nerve suture, recent skin transplantation, fragile organ such as eye.

Trial locations and contacts

1 site in 1 country.

France1 site

CRRF La Chataigneraie Convention
Paris, Île-de-France Region, 75015

Other trials in France

About this study

Official title: Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

Read the detailed description

This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each.

During the 38 week duration of the study, enrolled patients will be assessed at:

initial evaluation (first week of the study),
intermediary evaluation for every week and every modification of intensity of pain,
final evaluation at 10 weeks,
follow-up evaluation at 6 months.

Conditions: Allodynia
Being tested: Standard Medical treatment, Vibrotactile stimulation, Sham Stimulation with Vibradol device switched off
Keywords: static mechanical allodynia, somatosensory rehabilitation, vibrotactile stimulation
Medical subject headings: Hyperalgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Medical treatmentOther
Standard treatment with drugs and usual rehabilitation
Vibrotactile stimulationDevice
Rehabilitation by vibrotactile stimulation at medical center
Sham Stimulation with Vibradol device switched offDevice
Sham Rehabilitation at medical center but with Vibradol device switched off

Study groups in NCT02571010
Study group	Role	What they receive
Vibrotactile stimulation	Experimental	Patients in this arm will have * treatment by medications and rehabilitation * treatment by vibrotactile at medical center * stimulation at home by soft tissue * non stimulation on allodynia area Receives: Other: Standard Medical treatment; Device: Vibrotactile stimulation
Sham Stimulation with Vibradol device switched off	Sham comparator	Patients in this arm will have * treatment by medications and rehabilitation * Sham vibrotactile treatment at medical center but with Vibradol device switched off * abdominal breath exercises at home * non stimulation on allodynia area Receives: Other: Standard Medical treatment; Device: Sham Stimulation with Vibradol device switched off
Standard Medical treatment	Other	Observational group, treated as usually by medications and rehabilitation. Receives: Other: Standard Medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of baseline in reduction of surface of allodynia area
Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area
Measured: At baseline, each week during the 10 week treatment period and at 6 months

Secondary outcomes (5)

Change of baseline in reduction of pain
Reduction of pain will be evaluated by QDSA questionnaire.
Measured: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline in reduction of allodynia intensity
Reduction of allodynia intensity will be measured with the method with the colors
Measured: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline of patient's satisfaction with regard to received care
Patient's satisfaction with regard to pain relief will be evaluated by VAS
Measured: At baseline, at each week, at 10 weeks and at 6 months
Analgesics consumption
Amount of analgesic drugs
Measured: At 6 months
Afterglow effect
An evaluation of static mechanical allodynia in surface and intensity at 6 months
Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20152 May 2019

First posted8 Oct 2015 (estimated)
Study startOct 2015
Primary completion2 May 2019
Study completion2 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AllodyniaStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02571010
Sponsor's protocol ID: 14RBD-RESISTAL
Other IDs: 2014A013 08-39
Acronym: RESISTAL
Status last verified: Nov 2020
First submitted: 31 Aug 2015
Last updated: 12 Nov 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allodynia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration
ClinicalTrials.gov ID: NCT02571010
Acronym / sponsor ID: RESISTAL / 14RBD-RESISTAL
Conditions: Allodynia
Keywords: static mechanical allodynia, somatosensory rehabilitation, vibrotactile stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: CRRF La ChâtaigneraieUniversity, hospital or other
Collaborators: Hôpitaux Universitaires Paris Ile-de-Franc Ouest
Study start: Oct 2015 (actual)
Primary completion: 2 May 2019 (actual)
Study completion: 2 May 2019 (actual)
First posted: 8 Oct 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.

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

Detailed description

This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each.

During the 38 week duration of the study, enrolled patients will be assessed at:

initial evaluation (first week of the study),
intermediary evaluation for every week and every modification of intensity of pain,
final evaluation at 10 weeks,
follow-up evaluation at 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vibrotactile stimulation	Experimental	Other: Standard Medical treatment, Device: Vibrotactile stimulationPatients in this arm will have * treatment by medications and rehabilitation * treatment by vibrotactile at medical center * stimulation at home by soft tissue * non stimulation on allodynia area
Sham Stimulation with Vibradol device switched off	Sham comparator	Other: Standard Medical treatment, Device: Sham Stimulation with Vibradol device switched offPatients in this arm will have * treatment by medications and rehabilitation * Sham vibrotactile treatment at medical center but with Vibradol device switched off * abdominal breath exercises at home * non stimulation on allodynia area
Standard Medical treatment	Other	Other: Standard Medical treatmentObservational group, treated as usually by medications and rehabilitation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

Patient with neuralgia (spontaneous pain) with or without allodynia;
Patient not able to participate actively to the rehabilitation exercises for physical reason, cognitive reason (ability to understand instructions) or behavioural reason (e.g. addiction...);
Patient with complex regional pain syndrome (type I);
Patients for whom cares cannot avoid any touch with allodynia area;
Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);

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
Standard Medical treatmentStandard treatment with drugs and usual rehabilitation	Other	Sham Stimulation with Vibradol device switched off, Standard Medical treatment, Vibrotactile stimulation
Vibrotactile stimulationRehabilitation by vibrotactile stimulation at medical center	Device	Vibrotactile stimulation
Sham Stimulation with Vibradol device switched offSham Rehabilitation at medical center but with Vibradol device switched off	Device	Sham Stimulation with Vibradol device switched off

Primary outcome

Change of baseline in reduction of surface of allodynia area
Time frame: At baseline, each week during the 10 week treatment period and at 6 months
Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area

5 secondary outcomes

Change of baseline in reduction of pain
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline in reduction of allodynia intensity
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline of patient's satisfaction with regard to received care
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Analgesics consumption
Time frame: At 6 months
Afterglow effect
Time frame: At 6 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 12 Nov 2020.

Related trials for Allodynia

Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
RecruitingObservational study
Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)
Fibromyalgia, Chronic Pain
RecruitingPhase 3
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Fibromyalgia
Not yet recruiting
Multi-Segmental Spinal Manual Therapy in Women With Episodic Migraine
Migraine Disorders

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.

Rania Belmahfoud, MD study chair

CRRF La Chataigneraie Convention

Valérie Zingale study director

CRRF La Chataigneraie Convention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Medical treatment and Vibrotactile stimulation in people with Allodynia, run by CRRF La Châtaigneraie at 1 site 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 0 inclusion and 9 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 12 Nov 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 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. Some participants in this study may receive a placebo. 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?

Change of baseline in reduction of surface of allodynia area (time frame: At baseline, each week during the 10 week treatment period and at 6 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 NCT02571010.

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 12 Nov 2020.