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

Civil Hospices of Lyon

Status: Completed

Conditions: Breast Cancer

Treatments: Other: phone questionnaires; Other: Osteopathy sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT02621437

69HCL14_0456

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

161 participants in 2 patient groups

Intervention group (osteopathy)

Experimental group

Description:

Patients will have three sessions of osteopathy and 6 phone questionnaires.

Treatment:

Other: Osteopathy sessions

Other: phone questionnaires

control group

Other group

Description:

Patients will have 6 phone questionnaires.

Treatment:

Other: phone questionnaires