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Completed

NCT Number: NCT02621437

Impact of Osteopathy on Pain After 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de gynécologie

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Osteopathy sessions

Other
  • Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),

phone questionnaires

Other

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

Primary outcomes

  1. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: at Day 9

    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).

  2. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: at day 20

    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).

  3. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: at day 26

    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).

  4. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: at Day 34

    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).

  5. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: at Day 40

    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).

  6. Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery

    Time frame: 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 outcomes

  1. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: at day 9

    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.

  2. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: at day 20

    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.

  3. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: at day 26

    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.

  4. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: at day 34

    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.

  5. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: at day 40

    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.

  6. Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    Time frame: 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.

  7. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: at Day 9

    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.

  8. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: at Day 20

    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.

  9. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: at Day 26

    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.

  10. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: at Day 34

    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.

  11. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: at Day 40

    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.

  12. Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IPOD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2015
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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