Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

NCT ID: NCT02735668

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-02-29

Brief Summary

The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle activity and health-related quality of life.

Detailed Description

Introduction: chronic shoulder pain is a frequent consequence after breast cancer treatment with a reported prevalence of 25% to 60% and is commonly termed "Persistent Pain after Breast Cancer Treatment" (PPBCT). Frequently, PPBCT includes neuropathic pain due to damage of neural tissue during surgery. However, recent studies, consider that myofascial pain syndrome and heightened mechanosensitivity of neural tissue can be also present in this women. Although PPBCT is typically managed with pharmacological treatment,currently, physiotherapy is presented as an alternative method. Physiotherapy in relation to the shoulder, commonly, focuses its treatment with therapeutic exercise. In this sense, there is great controversy about which are the most appropriate exercises. Recent authors, bet for more precise and analytical exercises in relation with scapula and reject conventional exercises for the shoulder. Taking into account each of the sources of pain presented by these women and the benefits of therapeutic exercise, it would be interesting to study which approach of physiotherapy treatment would be more appropriate in these women.

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:

An experimental group, where the participants will be treated with Multimodal Physiotherapy;

Another experimental group where will be realized Scapular Exercises only;

And a third group where will be done Shoulder Conventional Exercises.

Pre- intervention, immediate post-intervention, 3, and 6 months assessments will be made. The selection criteria will be: women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months. The participants must understand and sign freely Informed Consent.

Sample size: 30 women for each group.

Data Analysis: A descriptive analysis of all variables will be performed. It will be established for all cases a confidence level of 95% (p <0.05). The effectiveness will be assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.

Conditions

Shoulder Pain; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shoulder Conventional Exercises

The protocol consists in:

• Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment.
• Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

Group Type: ACTIVE_COMPARATOR

Shoulder Conventional Exercises

Intervention Type: OTHER

The protocol consists in:

• Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:

• Mobilisation Joint Exercises.
• Isometrics and Resisted Exercises (elastic bands).

Therapeutic Education

Intervention Type: BEHAVIORAL

The protocol consists in:

Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.

Multimodal Physiotherapy

The protocol consists in:

• Dry Needling in active myofascial trigger points.
• Neurodynamic techniques.
• Scapular exercises.
• Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

Group Type: EXPERIMENTAL

Multimodal Physiotherapy

Intervention Type: OTHER

The protocol consists in:

• Dry Needling in active myofascial trigger points related to shoulder joint (optimal hygiene and disinfection before and after needling). Special care in muscles located in the arm in women with axillary node dissection.
• If Upper Limb Neural Tension Test is positive, neurodynamic techniques will be included.

Scapular exercises

Intervention Type: OTHER

The protocol consists in:

Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation.

Therapeutic Education

Intervention Type: BEHAVIORAL

The protocol consists in:

Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.

Scapular exercises

The protocol consists in:

• Scapular exercises
• Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

Group Type: EXPERIMENTAL

Scapular exercises

Intervention Type: OTHER

The protocol consists in:

Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation.

Therapeutic Education

Intervention Type: BEHAVIORAL

The protocol consists in:

Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.

Interventions

Shoulder Conventional Exercises

The protocol consists in:

• Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:

• Mobilisation Joint Exercises.
• Isometrics and Resisted Exercises (elastic bands).

Intervention Type: OTHER

Multimodal Physiotherapy

The protocol consists in:

• Dry Needling in active myofascial trigger points related to shoulder joint (optimal hygiene and disinfection before and after needling). Special care in muscles located in the arm in women with axillary node dissection.
• If Upper Limb Neural Tension Test is positive, neurodynamic techniques will be included.

Intervention Type: OTHER

Scapular exercises

The protocol consists in:

Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation.

Intervention Type: OTHER

Therapeutic Education

The protocol consists in:

Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.

Intervention Type: BEHAVIORAL

Other Intervention Names

Conventional physical therapy; Specific physical therapy; Specific physical therapy; Hygienic and behavioral advises

Eligibility Criteria

Inclusion Criteria

• Women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months.
• Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence).
• Women who have read, understood and signed informed consent freely

Exclusion Criteria

• Women treated with bilateral breast cancer.
• Women with shoulder pain episodes prior to breast cancer treatment.
• Women with predominant central sensitization pain identified by the Central Sensitization Inventory (> 40 points)
• Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Virginia Prieto Gómez

Research Expert of Healthcare (Msc)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virginia P Gómez, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy. University of Alcala.

Locations

Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

FPSM_UAH_VPG

Identifier Type: -

Identifier Source: org_study_id