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Impact of Osteopathy on Pain After Breast Cancer Surgery

NCT02621437 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Gil DUBERNARD, Pr · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621437 on ClinicalTrials.gov