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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder Conventional Exercises | Active Comparator | The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
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| Multimodal Physiotherapy | Experimental | The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
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| Scapular exercises | Experimental | The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder Conventional Exercises | Other | The protocol consists in: • Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain". | Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Disability | The questionnaire Shoulder Pain and Disability Index validated in Spanish, to measure the intensity and information on the characteristics of pain and the level of shoulder disability is used. This questionnaire contains a numerical scale from 0 to 10 to collect each answer. | At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia P Gómez, PhD Student | Department of Physiotherapy. University of Alcala. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala. | Alcalá de Henares | Madrid | 28871 | Spain |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| Multimodal Physiotherapy | Other | The protocol consists in:
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| Scapular exercises | 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. |
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| Therapeutic Education | 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. |
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| Root-Mean-Square (RMS) EMG Amplitude | Quantification of motor unit recruitment (electrical activity), by analyzing the RMS, expressed in microvolts (normalized data expressed as a percentage) of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement | At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required. |
| Onset EMG | Beginning of motor activation, expressed in seconds (s), of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement. | At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required. |
| Health-related quality of life | Questionnaire: Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4 | At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required. |
| Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used. | Travell and Simon's Criteria consists in (Wolfe et al 1992): The major criteria include:
Three minor criteria have been suggested to further aid in the diagnosis of myofascial pain syndrome:
| At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |