Nerve Mobilization Techniques After Breast Cancer Surgery

Breast Cancer Female Clinical Trial

— PT-ND-BC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250351
• Other study ID #: 12/2009
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: December 10, 2022

Study information

• Verified date: August 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: to determine nerve mobilization techniques effectiveness at improving shoulder disability in the early breast cancer postsurgical period, and whether the effect was maintained at 24-month follow up. 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. Hypothesis: nerve mobilization helps brachial plexus sliding among its interface which improves shoulder disability the inner arm. Key outcomes: pain, functional impairment, physical therapy, quality of life. Data analysis: quantitative variables through t-student test and qualitative variable though Chi test through by Statistical Package for the Social Sciences software.

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 ULNT1 will be perform to detect mechanosenstiviy-induced pain at presurgical and postsurgical assessments. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 10, 2022
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Neural mobilization group
See arm/group descriptions
• Control group
See arm/group descriptions

Locations

Country	Name	City	State
Spain	María Torres-Lacomba	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of shoulder disability	It will be measured by SPADI spanish validated version.	7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
Primary	Change of shoulder range of motion	It will be measured by an inclinometer under the universal instructions and validated of the goniometry.	7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline 7th after 24 months after intervention.
Primary	Change of strenght	It will be measured by a dynamometer under the universal instructions.	7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
Primary	Change of pain intensity	To measure the intensity and get the information on the characteristics (type of feeling, duration, aggravating factors and mitigating, irritability, nocturnal behavior and activities with the UL ...) will be used a validated questionnaire shoulder Pain and Disability Index (SPADI). Contains a numerical scale to collect each answer. The possible answers are 0 to 10, with 0 being no distress and 10 present such difficulty that needs help. The result of the questionnaire is between 0 (no pain) and 80 (the most pain possible).	7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
Primary	Change of health related quality of life	It will be measured by FACTB spanish validated version.	7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline

External Links

•   Physiotherapy in women´s health research group