PT-ND-BC: Nerve Mobilization Techniques After Breast Cancer Surgery

Sponsor

University of Alcala (Other)

Overall Status

Completed

CT.gov ID

NCT03250351

Collaborator

(none)

140

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: to determine nerve mobilization techniques effectiveness at improving shoulder mobility and arm sensitive disorders in the early breast cancer postsurgical period 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 six 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 Gynaecology and Obstetrics 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 sensitive disorders, pain and functionality of the inner arm. Key outcomes: range of motion, pain, sensitive disorder, functionality, 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Other: Neurodynamic techniques Other: Early physical therapy plus educational strategy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups: Experimental group & Control grupTwo groups: Experimental group & Control grup

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 10, 2017

Actual Primary Completion Date :

Dec 10, 2019

Actual Study Completion Date :

Feb 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurodynamic group 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program 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. 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: Neurodynamic techniques See arm/group descriptions Other: Early physical therapy plus educational strategy 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 consisting of physical therapy aimed at reducing postoperative edema, treatment of the scar, the muscle pain and / or joint and recovery and integration of the upper limb functional motor patterns plus instructions with printed material about lymphatic system, lymphedema, pain, movement & pain; etc…. (educational strategy). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.	Other: Early physical therapy plus educational strategy See arm/group descriptions

Arm

Intervention/Treatment

Experimental: Neurodynamic group

3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program 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. 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: Neurodynamic techniques

See arm/group descriptions

Other: Early physical therapy plus educational strategy

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 consisting of physical therapy aimed at reducing postoperative edema, treatment of the scar, the muscle pain and / or joint and recovery and integration of the upper limb functional motor patterns plus instructions with printed material about lymphatic system, lymphedema, pain, movement & pain; etc…. (educational strategy). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.

Other: Early physical therapy plus educational strategy

See arm/group descriptions

Outcome Measures

Primary Outcome Measures

Change of shoulder range of motion [6 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.]
It will be measured by an inclinometer under the universal instructions and validated of the goniometry.
Change of sensitive disorder [6 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]
Descriptive scale: Hypoesthesia, hyperesthesia, allodynia, mechanical allodynia.
Change of pain intensity [6 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]
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).
Change of shoulder disability [6 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]
It will be measured by SPADI spanish validated version.
Change of health related quality of life [6 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]
It will be measured by FACTB spanish validated version.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women treated for unilateral breast cancer with surgery, including lymphadenectomy or sentinel lymph node biopsy 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:

Women treated for unilateral breast cancer with no lymphadenectomy or no sentinel lymph node biopsy approach
Presence of lymphedema
Bilateral breast cancer
Systemic disease (metastases)
Infection
Loco regional recurrence.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	María Torres-Lacomba	Madrid		Spain	28024

Sponsors and Collaborators

University of Alcala

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Torres Lacomba, Professor, University of Alcala

ClinicalTrials.gov Identifier:

NCT03250351

Other Study ID Numbers:

12/2009

First Posted:

Aug 15, 2017

Last Update Posted:

Apr 7, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 7, 2020