- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735668
Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Madrid
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Alcalá de Henares, Madrid, Spain, 28871
- Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Shoulder Conventional Exercises
The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
The protocol consists in: • Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:
Other Names:
The protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.
Other Names:
|
Experimental: Multimodal Physiotherapy
The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
The protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.
Other Names:
The protocol consists in:
Other Names:
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.
Other Names:
|
Experimental: Scapular exercises
The protocol consists in:
The treatment duration is 1 day per week during 6 weeks. |
The protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain and Disability
Time Frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
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.
|
Root-Mean-Square (RMS) EMG Amplitude
Time Frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
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
Time Frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
Beginning of motor activation, expressed in seconds (s), of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement.
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At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
Health-related quality of life
Time Frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
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.
Time Frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virginia P Gómez, PhD Student, Department of Physiotherapy. University of Alcala.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPSM_UAH_VPG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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