A Clinical Trial of Mirror Treatment for Phantom Pain

NCT02912975 | Completed DMC

• 1 other identifier: 975 905 055
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.

Conditions

Phantom Limb Pain; Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• Phantom limb pain

  Assessed by self-rating by each study patient

  Change after three months as compared to preintervention level

Other Outcomes (1)

• Physical function

  Change after three months as compared to preintervention level

Study Arms (2)

Mirror treatment

EXPERIMENTAL

Five minutes treatment period twice a day for three weeks

Other: Tactile treatment

Tactile treatment

ACTIVE COMPARATOR

Tactile massage twice a day for three weeks

Other: Mirror treatment

Interventions

Mirror treatment OTHER

The mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient.

Tactile treatment

Tactile treatment OTHER

In Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material.

Mirror treatment

Eligibility Criteria

• Age: 16 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Present age \>16 years.
• Unilateral trans-tibial land mine amputation more than 12 months before entering the study.
• Suffering from phantom limb pain and/or CRPS-2.

You may not qualify if:

• Amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities.
• Chronic alcoholism or drug abuse.
• Loss or deformities of limbs other than the actual amputation.
• Mental and/or cognitive disorders making self-reporting unreliable.

Sponsors & Collaborators

• Trauma Care Foundation, Norway: lead
• University Hospital of North Norway: collaborator
• NCHADS - Ministry of Health of Cambodia: collaborator

Study Sites (1)

Trauma Care Foundation Cambodia

Battambang, 5004, Cambodia

Location

MeSH Terms

Conditions

Phantom Limb; Complex Regional Pain Syndromes

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; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Snorre Sollied, MD, PhD

  Department of Intensive Care, University Hospital North Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic head

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: September 23, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 15, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

CA (1)