Clinical Trials Directory

Trials / Completed

CompletedNCT02735668

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
University of Alcala · Academic / Other
Sex
Female
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERShoulder Conventional ExercisesThe 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).
OTHERMultimodal PhysiotherapyThe 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.
OTHERScapular exercisesThe 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.
BEHAVIORALTherapeutic EducationThe protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.

Timeline

Start date
2016-04-01
Primary completion
2021-02-01
Completion
2022-04-01
First posted
2016-04-13
Last updated
2026-03-09

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02735668. Inclusion in this directory is not an endorsement.