Clinical trial NCT02735668: Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment
Official title: Is Multimodal Physiotherapy More Effective Than Exercise Alone in Women With Peripheral Persistent Pain Following Breast Cancer Treatment? A Single-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Breast Cancer
Keywords: Shoulder Pain
Pattern Motor
Physical Therapy Modalities
Breast Cancer Treatment
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require
Secondary outcomes:
measure: Pain and Disability
timeFrame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
measure: Root-Mean-Square (RMS) EMG Amplitude
timeFrame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
measure: Onset EMG
timeFrame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
measure: Health-related quality of life
timeFrame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
measure: Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used.
timeFrame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
state: Madrid
Study officials:
affiliation: Department of Physiotherapy. University of Alcala.
name: Virginia P Gómez, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: