Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment

NCT02735668 | Completed DMC

• 1 other identifier: FPSM_UAH_VPG
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Breast Cancer

Keywords

Shoulder Pain; Pattern Motor; Physical Therapy Modalities; Breast Cancer Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Pain and Disability

  At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.

• Root-Mean-Square (RMS) EMG Amplitude

  At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.

• Onset EMG

  At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.

• Health-related quality of life

  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.

  At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.

Study Arms (3)

Shoulder Conventional Exercises

ACTIVE COMPARATOR

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.

Other: Shoulder Conventional Exercises; Behavioral: Therapeutic Education

Multimodal Physiotherapy

EXPERIMENTAL

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.

Other: Multimodal Physiotherapy; Other: Scapular exercises; Behavioral: Therapeutic Education

Scapular exercises

EXPERIMENTAL

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

Other: Scapular exercises; Behavioral: Therapeutic Education

Interventions

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.

Also known as: Specific physical therapy

Multimodal Physiotherapy

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.

Also known as: Hygienic and behavioral advises

Multimodal Physiotherapy; Scapular exercises; Shoulder Conventional Exercises

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).

Also known as: Conventional physical therapy

Shoulder Conventional Exercises

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.

Also known as: Specific physical therapy

Multimodal Physiotherapy; Scapular exercises

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

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

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Shoulder Pain; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Virginia P Gómez, PhD Student

  Department of Physiotherapy. University of Alcala.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Expert of Healthcare (Msc)

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2022
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)