Clinical trial NCT02912975: 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
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Complex Regional Pain Syndromes
Lead sponsor: Trauma Care Foundation, Norway
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: NCHADS - Ministry of Health of Cambodia
First posted: 2016-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Phantom limb pain
timeFrame: Change after three months as compared to preintervention level
Secondary outcomes:
Other outcomes:
measure: Physical function
timeFrame: Change after three months as compared to preintervention level
Locations:
city: Battambang
country: Cambodia
facility: Trauma Care Foundation Cambodia
Study officials:
affiliation: Department of Intensive Care, University Hospital North Norway
name: Snorre Sollied, MD, PhD
role: STUDY_DIRECTOR
References: