Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes

July 10, 2022 updated by: Omnia Saeed Mahmoud Ahmed, General Committee of Teaching Hospitals and Institutes, Egypt

Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain After Pain Management Protocol of Physiotherapy

The purpose of the Breast Cancer EDGE Task Force is to provide physiotherapists with a comprehensive list of outcome measures that can be administered to a selected patient population, to assess post-mastectomy pain syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Female breast cancer incidence rates are slowly increasing by about 0.5% each year since the mid-2000s, attributed a minimum of partially to continued declines in fertility and increases in excess weight. the best number of deaths are from cancers of the lung, prostate, and colorectum in men and of the lung, breast, and colorectum in women. Incidence from 2014 through 2018 continued a slow increase for female breast cancer. For women, breast cancer, and lung cancer, account for 51% of all new diagnoses, with breast cancer alone accounting for nearly one-third.

According to the literature, the prevalence of chronic pain after breast cancer treatment varies from 25% to 60% in other countries.

Survival rates for breast cancer vary worldwide, but normally, rates have improved. In most countries, the five-year survival rate of early-stage breast cancers is 80-90 percent, falling to 24 percent for breast cancers diagnosed at a more advanced stage.

A systematic review evaluating risk factors for the event of persistent pain after surgery found that additionally to younger age, preoperative pain, intercostobrachial nerve damage during surgery, radiotherapy, also psychological morbidities are among the foremost frequently reported factors associated with chronic pain after breast cancer treatment.

Surgery could be a mainstay of primary breast cancer therapy. Alterations in surgical technique have reduced normal tissue injury, yet pain and functional compromise continue to occur following treatment.

Assa suggested that damage to the intercostobrachial nerve (ICBN) is also chargeable for the event of persistent pain arises from the lateral cutaneous branch of the second intercostal nerve and enters the axilla by perforating the second intercostal space and musculus serratus anterior within the midaxillary line. It then passes with considerable variability to the posteromedial border of the upper arm, leaving the ICBN in danger of harm during axillary surgery Post-mastectomy pain syndrome (PMPS) could be a chronic pain condition, typically neuropathic, which might occur following surgery on the breast.

Pain may be a common complication of breast cancer surgery. The event of chronic pain is one of the foremost frequently seen sequelae within the cancer survivor population.

Persistent pain after mastectomy was first reported during the 1970s, characterized as a dull, burning, and aching sensation within the anterior chest, arm, and axilla, exacerbated by movement of the shoulder girdle.

Although the pain related to breast cancer surgery includes different conditions (e.g., phantom-breast pain, pain around the mastectomy scar, or pain within the anterior chest wall). neuropathic pain due to intercostobrachial neuropathy-i.e. painful intercostobrachial neuropathy-is the foremost representative type of pain in breast cancer survivors The exact explanation for PMPS is unclear, but various etiological theories are postulated, including dissection of the intercostobrachial nerve, intraoperative damage to axillary nerve pathways, and pain caused by a neuroma, although evidence regarding the epidemiology of PMPS is growing, little is known about risk factors for the event of PMPS, or the long-term outcome of this chronic pain condition.

the International Association for the Study of Pain has defined chronic pain as that persisting beyond the traditional healing time of three months. Chronic pain was defined as PMPS supported by three criteria: character, location, and timing of pain. The identical criteria for PMPS were used at both time points to make sure comparability. Pain location was recorded as the same side of surgery, chest wall, axilla, or ipsilateral arm.

And "unpleasant sensory and emotional experience related to actual or potential tissue damage, or described in terms of such damage".

As the lesion recovers or the threat disappears, the pain sensation should normally decrease. However, when the pain remains persistent after the traditional tissue healing process, it can be considered chronic.

But, Neuropathic pain (NP), is defined by the International Association for the Study of Pain (IASP) as ''pain arising as a direct consequence of a lesion or disease affecting the somatosensory system will be a vital source of disability and distress in breast cancer patients already laid low with the psychological and medical stressors related to diagnosis and treatment and has been considered the foremost important contributor to chronic breast pain.

Neuropathic pain following breast surgery is often characterized by radiating pain, numbness, pins, and needles, burning, or stabbing. and is often related to paresthesia and hypersensitivity near the operative site.

The development of postoperative neuropathic pain (NPP) is related to many psychosocial and medical stressors, and for several, it represents a failure to return to normal life The current literature shows that chronic pain is related to nerve damage associated with the surgical technique, adjuvant therapy (such as chemotherapy, radiotherapy, and endocrine therapy), and younger age. However, these findings are equivocal because there's a body of literature that found no association between chemotherapy and chronic pain.

An important portion of breast cancer survivors needs to cope with complications and sequelae physical (lymphedema, neuropathy/pain, fatigue, menopausal symptoms, weight gain, etc.) and psychological nature (fear of recurrence, fear of death, change in body image, change in relationship, financial stress, etc.). These complications can arise during the treatment or can persist long after treatment cessation.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Haram
      • Giza, Haram, Egypt, 12555
        • Baheya Centre for Early Detection and Treatment of Breast Cancer institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Chronic pain >= 3 months
  • Pain is localized to the chest wall or axilla.
  • The onset of pain is clearly after surgery or radiation therapy.
  • Pain is persistent, not fluctuating.
  • The patient is a minimum of 6 weeks post-radiation therapy.

Exclusion Criteria:

  • Time since surgery was less than 6 months.
  • The pain wasn't presented as an outcome, previous ipsilateral breast cancer, pregnancy, disease within the nervous system, psychiatric disease.
  • Time since diagnosis was less than 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

Seven of the 22 pain measures demonstrated satisfactory psychometric properties and clinical utility and are thereby recommended for clinical and research use in adults with a diagnosis of cancer.

Participants received Physical therapy program is critical to preserve flexibility, strength, range of motion, and normal neuromuscular recruitment. Patients' efforts to cut back their pain through avoidance behaviors can severely undermine function if mobility, activity of daily living, performance, or vocational capacity are affected. Physical therapy may involve trials of analgesic modalities like desensitization techniques, transcutaneous electrical nerve stimulation (TENS), and topical cold. Modality trials are rapid, relatively harmless, and inexpensive with the additional benefit that patients can self-administer effective treatments The pain management protocol of physiotherapy of PMPS depends mainly on education regarding the subsequent points that are paramount.
Other: questionnaires
Participants were recruited from the Baheya Centre for Early Detection and Treatment of Breast Cancer institution. Patients were eligible if they had a previously post-mastectomy pain syndrome (PMPS), and were presented with pain within the surgical area lasting more than 3 months. They were evaluated by questionnaires and methods of pain assessment then received their physiotherapy program specific for pain relief for six sessions, and so re-evaluation. All women gave informed written consent in Arabic and English forms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGill Pain Questionnaire-Short Form
Time Frame: baseline
15-word descriptors that describe two dimensions of pain: sensory and affective.
baseline
Numeric Rating Scale
Time Frame: baseline
the most ordinarily used one is the 11-item version, the rating of pain from (0 - 10).
baseline
Visual Analog Scale
Time Frame: baseline
is a 10 cm-long horizontal line with the words "no pain" at one end and "pain as bad as it can be" at the other.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory
Time Frame: baseline

There's a complete of 32 items on the Brief Pain Inventory, it describes pain interferes with 7 domains of function within the last 24 hours:

general activity, mood, walking ability, normal work, relations with people, sleep, and pleasure of life using a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
baseline
Brief Pain Inventory-Short Form
Time Frame: baseline
is a tool developed specifically to be used in individuals with cancer.
baseline
McGill Pain Questionnaire
Time Frame: baseline

is a unique measure because it assesses pain using a multidimensional approach based on the gate control theoretical framework.

contains three major classes of word descriptors: sensory, affective, and evaluative.
baseline
Pain Disability Index
Time Frame: baseline

is a multidimensional tool designed to measure the degree to of chronic pain affects an individual's ability to perform a variety of activities.

The PDI contains seven categories: family/home responsibility, recreation, social activity, occupation, sexual behavior, self-care, and life support activity.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

March 3, 2022

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 10, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103030005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-mastectomy Pain Syndrome

Clinical Trials on questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe