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Completed

NCT Number: NCT03250351

Nerve Mobilization Techniques After 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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

María Torres-Lacomba

Madrid, 28024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Neural mobilization group

Other

See arm/group descriptions

Control Group

Other

See arm/group descriptions

Primary outcomes

  1. Shoulder disability

    Time frame: 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 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.

Secondary outcomes

  1. Daily living-related shoulder pain

    Time frame: 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

    Daily living-related shoulder pain will be assessed using the SPADI pain subscale.

  2. Shoulder pain and related disability

    Time frame: 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 will be assessed using the total SPADI score.

Other outcomes

  1. Mechanosensitivity-related symptoms

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

    Mechanosensitivity-related symptoms will be identified using the Upper Limb Neurodynamic Test 1 (ULNT1)

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Acronym: PT-ND-BC

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Aug 15, 2017
Registry last updated
May 7, 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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