Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin

NCT03149432 | Completed DMC

• 1 other identifier: 2016-A00771-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.

Conditions

Amputation; Phantom Pain Following Amputation of Lower Limb

Keywords

mirror therapy; amputation; phantom pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the phantom limb pain using a VAS

  The EVA and the details of the analgesic treatment were collected every two weeks, blinded by an independent evaluator. Patients should not tell the evaluator which group they are assigned to.

  4 weeks

Secondary Outcomes (5)

• Change from baseline of the Frequency of phantom limb pain episodes

  every 2 weeks from day inclusion to Week 8

• change from baseline of the duration of phantom limb pain episodes.

  every 2 weeks from day inclusion to Week 8

• Change from baseline of the consumption of pharmacological analgesic drugs

  every 2 weeks from day inclusion to Week 8

• Quality of life? MEASUREMENT OF PAIN SENSATION

  every 2 weeks from day inclusion to Week 8

• Sleep disorders

  every 2 weeks from day inclusion to Week 8

Study Arms (2)

Reference analgesic

ACTIVE COMPARATOR

Gabapentin Rehabilitation Local care

Drug: Gabapentin; Procedure: Rehabilitation; Other: Local care

reference analgesic and mirror therapy

EXPERIMENTAL

Mirror Therapy Gabapentin Rehabilitation Local care

Procedure: Mirror Therapy; Drug: Gabapentin; Procedure: Rehabilitation; Other: Local care

Interventions

Mirror Therapy PROCEDURE

by a mirror effect the patient sees his remaining arm at the place of the amputated arm that cause an illusion of presence of this arm to the brain and would have an effect of reducing phantom pain

reference analgesic and mirror therapy

Gabapentin DRUG

titration of Gabapentin up to 3600 mg or maximum tolerated dose for 8 weeks

Reference analgesic; reference analgesic and mirror therapy

Rehabilitation PROCEDURE

Daily care with physiotherapist ; orthoprosthetists , and specialized sports educators ; if necessary : occupational therapy.

Reference analgesic; reference analgesic and mirror therapy

Local care OTHER

local care for directed healing of the stump.

Reference analgesic; reference analgesic and mirror therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age who signed the memorandum.
• Patient hospitalized in the service for setting up equipment.
• In the aftermath of a major amputation of the lower limb, of vascular origin.
• Patients with phantom pain greater than or equal to 30 Visual Analog Evaluation (EVA); Whether pharmacologically or not.

You may not qualify if:

• Refusal to participate in the study.
• Presence of cognitive or psychiatric disorders that compromise the realization of mirror therapy.
• Presence of neurological, rheumatological or orthopedic disorders that may prevent movement of the unaffected limb.

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Institut Merle d'Aubigné

Valenton, 94460, France

Location

Related Publications (1)

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

  PMID: 37276273 DERIVED

MeSH Terms

Conditions

Phantom Limb

Interventions

Mirror Movement Therapy; Gabapentin; Rehabilitation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Larlène Lacout, MD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assossor won't know if the participant has received the mirror therapy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: May 11, 2017
• Study Start: February 22, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-05

Locations

FR (1)