Impact of Osteopathy on Pain After Breast Cancer Surgery
NCT ID: NCT02621437
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
161 participants
INTERVENTIONAL
2016-02-29
2020-06-30
Brief Summary
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Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).
The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.
This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention group (osteopathy)
Patients will have three sessions of osteopathy and 6 phone questionnaires.
Osteopathy sessions
\- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
phone questionnaires
Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
* pain questionnaire with digital scale,
* quality of life survey: SF-12
* HAD (Hospital and Anxiety Depression) questionnaire
control group
Patients will have 6 phone questionnaires.
phone questionnaires
Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
* pain questionnaire with digital scale,
* quality of life survey: SF-12
* HAD (Hospital and Anxiety Depression) questionnaire
Interventions
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Osteopathy sessions
\- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
phone questionnaires
Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
* pain questionnaire with digital scale,
* quality of life survey: SF-12
* HAD (Hospital and Anxiety Depression) questionnaire
Eligibility Criteria
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Inclusion Criteria
* Surgery for a malignant breast tumor with sentinel lymph node technique
* Patient affiliated to a social security system
* Willing and able to provide written informed consent
Exclusion Criteria
* Pregnant woman
* Surgery for a malignant breast tumor with lymph node dissection
* Receiving adjuvant therapy during the study
* Receiving physiotherapy sessions (other than those made in immediate post-operative)
* Participating in the space "Au Fil de Soi": relaxing body massage and Energy Resonance by Cutaneous Stimulation (RESC)
* Person under guardianship or supervision
* Patient with impaired cognitive functions or lack of understanding of the French language
* Presenting a contraindication for osteopathy (major infectious and inflammatory conditions, trauma and other severe diseases)
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Gil DUBERNARD, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Service de gynécologie
Lyon, , France
Countries
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Other Identifiers
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69HCL14_0456
Identifier Type: -
Identifier Source: org_study_id
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