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A Clinical Trial of Mirror Treatment for Phantom Pain

Primary Purpose

Phantom Limb Pain, Complex Regional Pain Syndromes

Status
Completed
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Mirror treatment
Tactile treatment
Sponsored by
Trauma Care Foundation, Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain

Eligibility Criteria

16 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Trauma Care Foundation Cambodia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirror treatment

Tactile treatment

Arm Description

Five minutes treatment period twice a day for three weeks

Tactile massage twice a day for three weeks

Outcomes

Primary Outcome Measures

Phantom limb pain
Assessed by self-rating by each study patient

Secondary Outcome Measures

Full Information

First Posted
January 3, 2016
Last Updated
October 17, 2017
Sponsor
Trauma Care Foundation, Norway
Collaborators
University Hospital of North Norway, NCHADS - Ministry of Health of Cambodia
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1. Study Identification

Unique Protocol Identification Number
NCT02912975
Brief Title
A Clinical Trial of Mirror Treatment for Phantom Pain
Official Title
A Randomized Controlled Clinical Trial of Mirror Treatment in the Management of Phantom and Residual Limb Pain in Patients With Trans-tibial Land Mine Amputations in Cambodia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trauma Care Foundation, Norway
Collaborators
University Hospital of North Norway, NCHADS - Ministry of Health of Cambodia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered. Phase one: The study patients will be randomized for M or T treatment. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T); the responders (R) of the M, T and M+T enter the second phase of the study. The M+T non-responders discontinue the study. Phase two: The responders will be observed for a period of maximum three months. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. The main outcome indicators will be gathered at the start and the end of the second treatment period. The study closes at the end of the second treatment period. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Complex Regional Pain Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror treatment
Arm Type
Experimental
Arm Description
Five minutes treatment period twice a day for three weeks
Arm Title
Tactile treatment
Arm Type
Active Comparator
Arm Description
Tactile massage twice a day for three weeks
Intervention Type
Other
Intervention Name(s)
Mirror treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tactile treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phantom limb pain
Description
Assessed by self-rating by each study patient
Time Frame
Change after three months as compared to preintervention level
Other Pre-specified Outcome Measures:
Title
Physical function
Description
Assessed by questionnaire
Time Frame
Change after three months as compared to preintervention level

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snorre Sollied, MD, PhD
Organizational Affiliation
Department of Intensive Care, University Hospital North Norway
Official's Role
Study Director
Facility Information:
Facility Name
Trauma Care Foundation Cambodia
City
Battambang
ZIP/Postal Code
5004
Country
Cambodia

12. IPD Sharing Statement

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A Clinical Trial of Mirror Treatment for Phantom Pain

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