Nerve Mobilization Techniques After Breast Cancer Surgery

NCT03250351 | Completed DMC

• 1 other identifier: 12/2009
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Daily living-related shoulder pain

  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

  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 Outcomes (1)

• Mechanosensitivity-related symptoms

  Before surgery (A0) and 3-5 days after surgery (A1)

Study Arms (2)

Neural mobilization group

EXPERIMENTAL

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; Other: Control group

Control group

ACTIVE COMPARATOR

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

Interventions

Neural mobilization group OTHER

See arm/group descriptions

Neural mobilization group

Control group OTHER

See arm/group descriptions

Control group; Neural mobilization group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

María Torres-Lacomba

Madrid, Madrid, 28024, Spain

Location

Related Publications (4)

• 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.

  PMID: 20068255 BACKGROUND

• 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.

  PMID: 29860136 BACKGROUND

• 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.

  PMID: 35079831 BACKGROUND

• 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.

  PMID: 26001890 BACKGROUND

Related Links

• Physiotherapy in women´s health research group

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• María Torres-Lacomba, PhD

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As masking techniques, the people responsible for randomization of intervention in each group, the evaluation of subjects and data collection, the analysis of data will be independent. Participants are also masked, since we think they are unable to distinguish between NDG and CG interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups: Experimental group \& Control group

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 15, 2017
• Study Start: August 10, 2017
• Primary Completion: November 10, 2020
• Study Completion: December 10, 2022
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)