Nerve Mobilization Techniques After Breast Cancer Surgery (PT-ND-BC)

Effectiveness of Nerve Mobilization Techniques at Improving Upper Limb Morbidity Following Breast Cancer Surgery

Objective: To determine whether adding neurodynamic mobilization to early postoperative physiotherapy improves long-term shoulder disability after breast cancer surgery with axillary lymph node dissection. Design: prospective randomized and single blind trial where participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up will be conducted through seven physical therapy assessments: one before surgery, the second one after surgery, the third one post-physical therapy intervention, the fourth one after three months, the fifth after six months and, the sixth one after twelve months, and the seven one after 24 months. Participants: one hundred and forty women, who are undergoing a unilateral breast cancer surgery with axillary lymph node dissection in the Breast Cancer Unit from "Príncipe de Asturias" Hospital. Intervention: Early physical therapy to control group and Early physical therapy plus nerve mobilization to intervention group during the three following weeks from surgery. Mechanosensitivity-related symptoms will be assessed using the Upper Limb Neurodynamic Test 1 (ULNT1) before and after surgery. The primary outcome will be shoulder disability, measured with the disability subscale of the Shoulder Pain and Disability Index (SPADI). Secondary outcomes will include shoulder pain related to activities of daily living and the total SPADI score.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: Neural mobilization group; Other: Control group

Detailed Description

After giving their written informed consent, the participants will be summoned to perform the first assessment prior to surgery. Once participants will be discharged from hospital, approximately 3-5 days following the surgery, will be summoned to perform the second assessment. Those who will fulfil the selection criteria will be randomly allocated into two groups by an independent physical therapist. The experimental group will receive Early Physical Therapy plus neural mobilization and the control group will receive Early Physical Therapy. The same physical therapist will carry out all interventions for both groups. The physical therapist who will carry out the randomization process as well as the one who will perform the interventions will be the only two study members aware of group allocation. A third independent and blinded physical therapist will perform the assessments for all participants. Both physical therapists have more than fifteen years' experience in the treatment of breast cancer side effects. The Upper Limb Neurodynamic Test 1 (ULNT1) will be performed before surgery and after surgery to assess mechanosensitivity-related symptoms.The test sequence and the criteria will be followed to identify a positive test will reproduce from de study of de la Rosa.

In both groups, those women who will develop axillary web syndrome symptoms will receive an approach that aim at improving vascular tissue flexibility. If secondary lymphoedema will diagnose then complex decongestive physiotherapy will carry out.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28024
      • María Torres-Lacomba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women treated for unilateral breast cancer with surgery, including axillary lymph node dissection at the Department of Gynecology and Obstetrics of "Príncipe de Asturias" Hospital
• No contraindication to physical therapy
• Informed consent read, understood, and freely signed

Exclusion Criteria:

• Bilateral breast cancer
• Systemic disease (metastases)
• Infection
• Loco regional recurrence
• Chemotherapy as a neoadjuvant treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural mobilization group; 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M) plus neurodynamic techniques consisting of neural tissue longitudinal glide using the Upper Limb Neurodynamic Test 1 (ULNT1), the neurodynamic test sequence for the median nerve, described by Butler and adapted by de la Rosa. With participants in the supine position, the shoulder was abducted and externally rotated, the scapula depressed, the forearm supinated, and the wrist and fingers extended. Mobilization was applied by depressing the scapula, flexing the elbow, and elevating the scapula, extending the elbow, within a pain-free range. The mobilization was applied for 2 minutes. Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.	Other: Neural mobilization group; See arm/group descriptions; Other: Control group; See arm/group descriptions
Active Comparator: Control group; 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.	Other: Control group; See arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder disability	Shoulder disability will be assessed using the disability subscale of the Shoulder Pain and Disability Index (SPADI), which is a valid and reliable measure in breast cancer survivors.	Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily living-related shoulder pain	Daily living-related shoulder pain will be assessed using the SPADI pain subscale.	Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment
Shoulder pain and related disability	Shoulder pain and related disability will be assessed using the total SPADI score.	Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanosensitivity-related symptoms	Mechanosensitivity-related symptoms will be identified using the Upper Limb Neurodynamic Test 1 (ULNT1)	Before surgery (A0) and 3-5 days after surgery (A1)

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: María Torres-Lacomba, PhD, University of Alcala

Publications and helpful links

General Publications

• Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.
• de la Rosa-Diaz I, Torres-Lacomba M, Acosta-Ramirez P, Orive IG, Nee RJ, de la Villa-Polo P, Andres-Esteban EM, Sanchez-Sanchez B. Protective myoelectric activity at performing upper limb neurodynamic test 1 in breast cancer survivors. A cross-sectional observational study. Musculoskelet Sci Pract. 2018 Aug;36:68-80. doi: 10.1016/j.msksp.2018.05.003. Epub 2018 May 22.
• Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.
• Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y.

Helpful Links

• Physiotherapy in women´s health research group

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 12/2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No