Impact of Osteopathy on Pain After Breast Cancer Surgery (IPOD)

Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Osteopathy sessions; Other: phone questionnaires

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de Gynécologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (osteopathy); Patients will have three sessions of osteopathy and 6 phone questionnaires.	Other: Osteopathy sessions; - Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),; Other: 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
Other: control group; Patients will have 6 phone questionnaires.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at Day 9
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at day 20
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at day 26
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at Day 34
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at Day 40
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery	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).	at Day 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 9
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 20
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 26
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 34
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 40
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.	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.	at day 48
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 9
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 20
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 26
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 34
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 40
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.	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.	at Day 48

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gil DUBERNARD, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: pain; quality of life; oncology; surgery; breast; osteopathy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 69HCL14_0456