NCT02146716

Brief Summary

The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

May 19, 2014

Last Update Submit

August 22, 2017

Conditions

Keywords

RESC, alcohol withdrawal syndrome

Outcome Measures

Primary Outcomes (1)

  • Cushman Score measure after Energetic Resonance by Cutaneous Stimulation

    CUSHMAN score is represented by a scale with 7 variables collecting physiological modifications or behavioural manifestations related to adrenergic answer, neurovegetative signs, confusion, nervousness, perceptive or hallucinatory phenomena.

    daily during one week

Secondary Outcomes (4)

  • Anxiety depression scale

    pre-screening, day 3 and day 7

  • prescribed benzodiazepine amount

    day 0 to day 7

  • Analogic Visual Scale

    before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.

  • Quality of life scale

    day 0

Study Arms (2)

Control

NO INTERVENTION

Energetic Resonance by Cutaneous Stimulation

EXPERIMENTAL

Energetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms.

Other: Energetic Resonance by Cutaneous Stimulation

Interventions

Energetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points.

Energetic Resonance by Cutaneous Stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 and 80 years,
  • Patient with alcohol addiction,
  • Patient needing alcohol withdrawal in a hospital.
  • Patient with social Security,
  • Patient with inform consent signed.

You may not qualify if:

  • Pregnant women
  • Minor.
  • Major with guardianship.
  • People without sufficient information because of troubles of cognitive functions, or without sufficient knowledge of French language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital croix rousse

Lyon, France

Location

Study Officials

  • Claude Augustin-Normand, Dr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 26, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations