Impact of Osteopathy on Pain After Breast Cancer Surgery

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Osteopathy sessions; Other: phone questionnaires

• Registration Number: NCT02621437
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-03
• Study Start: 2016-02
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

Inclusion Criteria

• Adult woman
• 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

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Exclusion Criteria

• Under-age women
• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (osteopathy)	Osteopathy sessions	Patients will have three sessions of osteopathy and 6 phone questionnaires.
Intervention group (osteopathy)	phone questionnaires	Patients will have three sessions of osteopathy and 6 phone questionnaires.
control group	phone questionnaires	Patients will have 6 phone questionnaires.

Primary Outcome Measures

Name	Time	Method
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	at Day 48	The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	at day 48	Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	at Day 48	Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.

Trial Locations

Locations (1)

Service de gynécologie; 🇫🇷 Lyon, France