A Clinical Trial of Mirror Treatment for Phantom Pain

Not Applicable

Completed

• Conditions: Complex Regional Pain Syndromes; Phantom Limb Pain
• Interventions: Other: Tactile treatment; Other: Mirror treatment

• Registration Number: NCT02912975
• Lead Sponsor: Trauma Care Foundation, Norway

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.

Study Timeline

• Study First Submitted: 2016-01-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2017-03
• Study Completion: 2017-07-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mirror treatment	Tactile treatment	Five minutes treatment period twice a day for three weeks
Tactile treatment	Mirror treatment	Tactile massage twice a day for three weeks

Primary Outcome Measures

Name	Time	Method
Phantom limb pain	Change after three months as compared to preintervention level	Assessed by self-rating by each study patient

Trial Locations

Locations (1)

Trauma Care Foundation Cambodia; 🇰🇭 Battambang, Cambodia