Physical Exercise, Motor Activity and Post-mastectomy Pain Syndrome.

NCT05713786 | Completed

• 1 other identifier: BRCAMA
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain. Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.

Conditions

Chronic Pain

Keywords

Chronic pain; Post mastectomy pain syndrome; Motor activity; Pain markers

Outcome Measures

Primary Outcomes (2)

• Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.

  Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10).

  Evaluation performed three and six months after surgery

• Effects of motor and/or sports activity on interference of chronic pain in women underwent mastectomy.

  Interference of pain in activities of daily living is a key biomarker for establishing adequate pain therapy. Interference of pain measured with the Brief Pain Inventory - Short Form. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily activities. Each item is scored on a 10 point numeric rating scale where 0 = no interference/pain and 10 = severe or complete interference/pain.

  Evaluation performed three and six months after surgery

Secondary Outcomes (2)

• Biomarkers of inflammation.

  Evaluation performed three and six months after surgery

• Biomarkers of oxidative stress

  Evaluation performed three and six months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer.

You may qualify if:

• over the age of 18 with a diagnosis of previous Stages I-III breast cancer.

You may not qualify if:

• medical history of other types of cancer;
• disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
• recent symptoms of illness (cough, fever);
• waiting breast reconstruction;
• not chemotherapy or radiation during the first six months after surgery:

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, 98125, Italy

Location

Related Publications (9)

• Calapai M, Esposito E, Puzzo L, Vecchio DA, Blandino R, Bova G, Quattrone D, Mannucci C, Ammendolia I, Mondello C, Gangemi S, Calapai G, Cardia L. Post-Mastectomy Pain: An Updated Overview on Risk Factors, Predictors, and Markers. Life (Basel). 2021 Sep 29;11(10):1026. doi: 10.3390/life11101026.

  PMID: 34685397 BACKGROUND

• Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.

  PMID: 26267006 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Tait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30.

  PMID: 29966772 BACKGROUND

• Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.

  PMID: 30586070 BACKGROUND

• Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

  PMID: 3461421 BACKGROUND

• Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.

  PMID: 29392241 BACKGROUND

• Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.

  PMID: 17426506 BACKGROUND

• Kaushik AS, Strath LJ, Sorge RE. Dietary Interventions for Treatment of Chronic Pain: Oxidative Stress and Inflammation. Pain Ther. 2020 Dec;9(2):487-498. doi: 10.1007/s40122-020-00200-5. Epub 2020 Oct 21.

  PMID: 33085012 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gioacchino Calapai, MD

  Azienda Ospedaliera Universitaria "G. Martino"

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 6, 2023
• Study Start: September 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

IT (1)