Impact of Osteopathy on Pain After Breast Cancer Surgery

Breast Cancer Clinical Trial

— IPOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621437
• Other study ID #: 69HCL14_0456
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2020

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Service de gynécologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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