Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

University of Alcala

Status: Completed

Conditions: Breast Cancer; Shoulder Pain

Treatments: Other: Multimodal Physiotherapy; Behavioral: Therapeutic Education; Other: Shoulder Conventional Exercises; Other: Scapular exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT02735668

FPSM_UAH_VPG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Shoulder Conventional Exercises

Active Comparator group

Description:

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.

Treatment:

Behavioral: Therapeutic Education

Other: Shoulder Conventional Exercises

Multimodal Physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Scapular exercises

Behavioral: Therapeutic Education

Other: Multimodal Physiotherapy

Scapular exercises

Experimental group

Description:

The protocol consists in: * Scapular exercises * Therapeutic Education about chronic shoulder pain. The treatment duration is 1 day per week during 6 weeks.

Treatment:

Other: Scapular exercises

Behavioral: Therapeutic Education