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Completed

NCT Number: NCT02735668

Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

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.

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Key information

Conditions

Shoulder Pain Arthralgia Breast Cancer Breast Diseases Breast Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Alcalá de Henares, Madrid, 28871, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shoulder Conventional Exercises

Other

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).

Other names: Conventional physical therapy

Multimodal physiotherapy

Other

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.

Other names: Specific physical therapy

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.

Other names: Specific physical therapy

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.

Other names: Hygienic and behavioral advises

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2016
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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