Skip to main content
OpenTrials
Completed

NCT Number: NCT02912975

A Clinical Trial of Mirror Treatment for Phantom Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Phantom Limb Pain Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Phantom Limb Postoperative Complications Signs and Symptoms

Age range

16 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trauma Care Foundation Cambodia

Battambang, 5004, Cambodia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Phantom limb pain

    Time frame: Change after three months as compared to preintervention level

    Assessed by self-rating by each study patient

Other outcomes

  1. Physical function

    Time frame: Change after three months as compared to preintervention level

    Assessed by questionnaire

Sponsors and collaborators

Lead sponsor

Trauma Care Foundation, Norway

Other

Collaborators

  • NCHADS - Ministry of Health of Cambodia
  • University Hospital of North Norway

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2016
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.