NCT02571010

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

August 31, 2015

Last Update Submit

November 10, 2020

Conditions

Allodynia

Keywords

static mechanical allodyniasomatosensory rehabilitationvibrotactile stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline, each week during the 10 week treatment period and at 6 months

Secondary Outcomes (5)

  • Change of baseline in reduction of pain

    At baseline, at each week, at 10 weeks and at 6 months

  • Change of baseline in reduction of allodynia intensity

    At baseline, at each week, at 10 weeks and at 6 months

  • Change of baseline of patient's satisfaction with regard to received care

    At baseline, at each week, at 10 weeks and at 6 months

  • Analgesics consumption

    At 6 months

  • Afterglow effect

    At 6 months

Study Arms (3)

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

Other: Standard Medical treatmentDevice: 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

Other: Standard Medical treatmentDevice: Sham Stimulation with Vibradol device switched off

Standard Medical treatment

OTHER

Observational group, treated as usually by medications and rehabilitation.

Other: Standard Medical treatment

Interventions

Standard Medical treatmentOTHER

Standard treatment with drugs and usual rehabilitation

Sham Stimulation with Vibradol device switched offStandard Medical treatmentVibrotactile stimulation
Vibrotactile stimulationDEVICE

Rehabilitation by vibrotactile stimulation at medical center

Vibrotactile stimulation
Sham Stimulation with Vibradol device switched offDEVICE

Sham Rehabilitation at medical center but with Vibradol device switched off

Sham Stimulation with Vibradol device switched off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRRF La Chataigneraie Convention

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rania Belmahfoud, MD

    CRRF La Chataigneraie Convention

    STUDY CHAIR

  • Valérie Zingale

    CRRF La Chataigneraie Convention

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

FR(1)