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

NCT05458154 | Completed DMC

• 1 other identifier: 202103030005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-mastectomy Pain Syndrome

Keywords

breast cancer; mastectomy; pain; syndrome; Assessment; EDGE task force; physiotherapy

Outcome Measures

Primary Outcomes (3)

• McGill Pain Questionnaire-Short Form

  15-word descriptors that describe two dimensions of pain: sensory and affective.

  baseline

• Numeric Rating Scale

  the most ordinarily used one is the 11-item version, the rating of pain from (0 - 10).

  baseline

• Visual Analog Scale

  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 Outcomes (4)

• Brief Pain Inventory

  baseline

• Brief Pain Inventory-Short Form

  baseline

• McGill Pain Questionnaire

  baseline

• Pain Disability Index

  baseline

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Interventions

questionnaires OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

Baheya Centre for Early Detection and Treatment of Breast Cancer institution

Giza, Haram, 12555, Egypt

Location

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MeSH Terms

Conditions

Breast Neoplasms; Pain; Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical therapy

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 14, 2022
• Study Start: March 3, 2021
• Primary Completion: March 3, 2022
• Study Completion: April 4, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

EG (1)