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

CRRF La Châtaigneraie

Status: Completed

Conditions: Allodynia

Treatments: Device: Sham Stimulation with Vibradol device switched off; Device: Vibrotactile stimulation; Other: Standard Medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02571010

2014A013 08-39 (Registry Identifier)

14RBD-RESISTAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

1. Male or female patients aged ≥18 years;
2. Static mechanical allodynia for less than 3 months, whatever its etiology and topography;
3. Probable peripheral or central neuropathic pain or defined according to the IASP criteria;
4. Neuropathic pain diagnostic questionnaire DN4 score ≥ 4/10;
5. Chronic pain with average intensity ≥ 4/10;
6. Analgesic treatment unchanged within 15 days prior to screening, and not planned to be modified during the study;
7. Patient who can attend follow-up visits during the study;
8. Patient affiliated to a health insurance plan or entitled;
9. Patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion Criteria:

1. Patient with neuralgia (spontaneous pain) with or without allodynia;
2. 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...);
3. Patient with complex regional pain syndrome (type I);
4. Patients for whom cares cannot avoid any touch with allodynia area;
5. Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
6. Prior treatment by somatosensory rehabilitation;
7. Duration of stay in the medical center < 11 weeks;
8. Patient with cognitive disorder;
9. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups

Vibrotactile stimulation

Experimental group

Description:

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

Treatment:

Device: Vibrotactile stimulation

Other: Standard Medical treatment

Sham Stimulation with Vibradol device switched off

Sham Comparator group

Description:

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

Treatment:

Other: Standard Medical treatment

Device: Sham Stimulation with Vibradol device switched off

Standard Medical treatment

Other group

Description:

Observational group, treated as usually by medications and rehabilitation.

Treatment:

Other: Standard Medical treatment