Amputation Clinical Trial
— MIR-PHANOfficial title:
Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin
Verified date | May 2019 |
Source | Centre d'Investigation Clinique et Technologique 805 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient over 18 years of age who signed the memorandum. - Patient hospitalized in the service for setting up equipment. - In the aftermath of a major amputation of the lower limb, of vascular origin. - Patients with phantom pain greater than or equal to 30 Visual Analog Evaluation (EVA); Whether pharmacologically or not. Exclusion Criteria: - Refusal to participate in the study. - Presence of cognitive or psychiatric disorders that compromise the realization of mirror therapy. - Presence of neurological, rheumatological or orthopedic disorders that may prevent movement of the unaffected limb. |
Country | Name | City | State |
---|---|---|---|
France | Institut Merle d'Aubigné | Valenton |
Lead Sponsor | Collaborator |
---|---|
Centre d'Investigation Clinique et Technologique 805 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline of the phantom limb pain using a VAS | The EVA and the details of the analgesic treatment were collected every two weeks, blinded by an independent evaluator. Patients should not tell the evaluator which group they are assigned to. | 4 weeks | |
Secondary | Change from baseline of the Frequency of phantom limb pain episodes | Frequencies of painful attacks were collected every two weeks, blinded by an independent evaluator. Patients should not tell the evaluator which group they are assigned to. | every 2 weeks from day inclusion to Week 8 | |
Secondary | change from baseline of the duration of phantom limb pain episodes. | Duration of painful attacks were collected every two weeks, blinded by an independent evaluator. Patients should not tell the evaluator which group they are assigned to. | every 2 weeks from day inclusion to Week 8 | |
Secondary | Change from baseline of the consumption of pharmacological analgesic drugs | The consumption of pharmacological analgesic drugs were collected every two weeks, blinded by an independent evaluator. Patients should not tell the evaluator which group they are assigned to. | every 2 weeks from day inclusion to Week 8 | |
Secondary | Quality of life? MEASUREMENT OF PAIN SENSATION | SF12 | every 2 weeks from day inclusion to Week 8 | |
Secondary | Sleep disorders | Spiegel Questionnaire | every 2 weeks from day inclusion to Week 8 |
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