A Clinical Trial of Mirror Treatment for Phantom Pain | NCT02912975

Studies
A Clinical Trial of Mirror Treatment for Phantom Pain

NCT02912975

Sponsor

Trauma Care Foundation, Norway

Status

Completed

Last Update Posted

Oct 18, 2017Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Phantom Limb Pain
Complex Regional Pain Syndromes

Interventions

Mirror treatment
Tactile treatment

Countries

Cambodia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Jul 15, 2017Actual

First Submitted Date

Jan 3, 2016

First Submission Date that Met QC Criteria

Sep 21, 2016

First Posted Date

Sep 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2017

Last Update Posted Date

Oct 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hans Husum, Clinic head, Trauma Care Foundation, NorwayPrincipal Investigator

Lead Sponsor

Trauma Care Foundation, NorwayOTHER

Collaborators

Name	Class
University Hospital of North Norway	OTHER
NCHADS - Ministry of Health of Cambodia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Physical function	Assessed by questionnaire	Change after three months as compared to preintervention level

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Snorre Sollied, MD, PhD	Department of Intensive Care, University Hospital North Norway	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trauma Care Foundation Cambodia		Battambang		5004	Cambodia

Condition Browse Module

MeSH Terms

ID	Term
D010591	Phantom Limb
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided