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Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

Primary Purpose

Shoulder Pain, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Shoulder Conventional Exercises
Multimodal Physiotherapy
Scapular exercises
Therapeutic Education
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Pattern Motor, Physical Therapy Modalities, Breast Cancer Treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Shoulder Conventional Exercises

Multimodal Physiotherapy

Scapular exercises

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Pain Intensity
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".

Secondary Outcome Measures

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.
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
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.
Health-related quality of life
Questionnaire: Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4
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: A patient's regional pain complaint; Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle; Identification of a palpable taut band; As well as a palpable, and exquisitely tender spot along the length of that taut band; Some degree of restricted range of motion of the involved muscle. Three minor criteria have been suggested to further aid in the diagnosis of myofascial pain syndrome: Palpation of a trigger point should reproduce the clinical pain complaint; A local twitch response may be elicited by transverse snapping or needling of the trigger point; The alleviation of pain by trigger point inactivation.

Full Information

First Posted
April 3, 2016
Last Updated
July 28, 2023
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT02735668
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Breast Cancer
Keywords
Shoulder Pain, Pattern Motor, Physical Therapy Modalities, Breast Cancer Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shoulder Conventional Exercises
Arm Type
Active Comparator
Arm 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.
Arm Title
Multimodal Physiotherapy
Arm Type
Experimental
Arm 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.
Arm Title
Scapular exercises
Arm Type
Experimental
Arm Description
The protocol consists in: Scapular exercises Therapeutic Education about chronic shoulder pain. The treatment duration is 1 day per week during 6 weeks.
Intervention Type
Other
Intervention Name(s)
Shoulder Conventional Exercises
Other Intervention Name(s)
Conventional physical therapy
Intervention Description
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
Intervention Name(s)
Multimodal Physiotherapy
Other Intervention Name(s)
Specific physical therapy
Intervention Description
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
Intervention Name(s)
Scapular exercises
Other Intervention Name(s)
Specific physical therapy
Intervention Description
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
Behavioral
Intervention Name(s)
Therapeutic Education
Other Intervention Name(s)
Hygienic and behavioral advises
Intervention Description
The protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Time Frame
Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require
Secondary Outcome Measure Information:
Title
Pain and Disability
Description
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.
Time Frame
At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Title
Root-Mean-Square (RMS) EMG Amplitude
Description
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
Time Frame
At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Title
Onset EMG
Description
Beginning of motor activation, expressed in seconds (s), of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement.
Time Frame
At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Title
Health-related quality of life
Description
Questionnaire: Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4
Time Frame
At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Title
Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used.
Description
Travell and Simon's Criteria consists in (Wolfe et al 1992): The major criteria include: A patient's regional pain complaint; Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle; Identification of a palpable taut band; As well as a palpable, and exquisitely tender spot along the length of that taut band; Some degree of restricted range of motion of the involved muscle. Three minor criteria have been suggested to further aid in the diagnosis of myofascial pain syndrome: Palpation of a trigger point should reproduce the clinical pain complaint; A local twitch response may be elicited by transverse snapping or needling of the trigger point; The alleviation of pain by trigger point inactivation.
Time Frame
At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia P Gómez, PhD Student
Organizational Affiliation
Department of Physiotherapy. University of Alcala.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

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