Clinical trial NCT02571010: Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allodynia
Keywords: static mechanical allodynia
somatosensory rehabilitation
vibrotactile stimulation
Lead sponsor: CRRF La Châtaigneraie
Sponsor class: OTHER
Collaborators: name: Hôpitaux Universitaires Paris Ile-de-Franc Ouest
First posted: 2015-10-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change of baseline in reduction of surface of allodynia area
timeFrame: At baseline, each week during the 10 week treatment period and at 6 months
Secondary outcomes:
measure: Change of baseline in reduction of pain
timeFrame: At baseline, at each week, at 10 weeks and at 6 months
measure: Change of baseline in reduction of allodynia intensity
timeFrame: At baseline, at each week, at 10 weeks and at 6 months
measure: Change of baseline of patient's satisfaction with regard to received care
timeFrame: At baseline, at each week, at 10 weeks and at 6 months
measure: Analgesics consumption
timeFrame: At 6 months
measure: Afterglow effect
timeFrame: At 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: CRRF La Chataigneraie Convention
state: Île-de-France
Study officials:
affiliation: CRRF La Chataigneraie Convention
name: Rania Belmahfoud, MD
role: STUDY_CHAIR
affiliation: CRRF La Chataigneraie Convention
name: Valérie Zingale
role: STUDY_DIRECTOR
References: