EMG at Performing ULTN 1 in Breast Cancer Patients

NCT ID: NCT02599467

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

Brief Summary

Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test for the median nerve, called upper limb neurodynamic test 1 (ULNT1). Design: A matched case-control observational study. Objective: to check the increased upper limb mechanosensitivity by shoulder range of motion (ROM) during ULNT1 and to determine, for the first time, the evoked electromyographic (EMG) muscle activity. Participants: 62 cases who underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital, Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity, breast cancer, pain, EMG, shoulder ROM, median nerve.

Detailed Description

Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test for the median nerve, called upper limb neurodynamic test 1 (ULNT1).A neural provocation test is a sequence of movements designed to assess the mechanics and physiology of part of the nervous system by elongating the length of the nerve bedding and by increasing the pressure in and around the peripheral nerve .The most reliable test to assess the upper limb neural mechanosensitivity is the neural provocation test for the median nerve, called upper limb neurodynamic test 1 (ULNT1). This test consists of depressing shoulder girdle in a neutral position, shoulder abduction and lateral rotation, elbow extension, forearm supination and wrist extension. Cervical contralateral lateral flexion may be included to further increase the loading of the brachial plexus and, as a sensitizing maneuver, to differentiate structurally between neural and non-neural involvement. The ULNT1 is considered as positive when symptoms are reproduced on affected upper limb, or side-to-side differences in ROM, or symptoms modified by lateral neck side-bending. Likewise, It is also necessary to assess the EMG activity of the involved muscles to verify the early and increased protective muscle response suggested throughout the neural strain performance.

It is also necessary to assess the EMG activity of the involved muscles to verify the early and increased protective muscle response suggested throughout the neural strain performance. Design: A matched case-control observational study. Objective: to check the increased upper limb mechanosensitivity by shoulder ROM during ULNT1 and to determine, for the first time, the evoked EMG muscle activity. Participants: 62 cases who underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital, Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity, breast cancer, pain, EMG, shoulder ROM, median nerve.

Conditions

Physiotherapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

case group 1: ALND

Inclusion criteria: unilateral breast cancer surgery with Axillary lymph node dissection (ALND) during the last year and a half. Exclusion criteria: bilateral breast cancer, ipsilateral shoulder pathology, neuropathy.

Procedure: ULNT 1 and EMG recording.

Group Type: EXPERIMENTAL

ULNT 1 and EMG recording

Intervention Type: OTHER

While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.

case group 2: SLNB

Inclusion criteria: unilateral breast cancer surgery with Sentinel Lymph Node Biopsy (SLNB) during the last year and a half. Exclusion criteria: bilateral breast cancer, ipsilateral shoulder pathology, neuropathy.

Procedure: ULNT 1 and EMG recording

Group Type: EXPERIMENTAL

ULNT 1 and EMG recording

Intervention Type: OTHER

While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.

control group

Matched by age and dominant arm to each case. Exclusion criteria: current painful conditions involving their neck or dominant upper-extremity, and chronic pain conditions or use of pain relievers.

Procedure: ULNT 1 and EMG recording.

Group Type: ACTIVE_COMPARATOR

ULNT 1 and EMG recording

Intervention Type: OTHER

While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.

Interventions

ULNT 1 and EMG recording

While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• No undergo breast cancer.
• To be the age and the sema dominant arm than one of the cases.

Exclusion Criteria

• Current painful conditions involving their neck or dominant upper-extremity.
• Chronic pain conditions (i.e. Fibromyalgia).
• Current use of pain relievers.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

IRENE DE LA ROSA DÍAZ

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María Torres-Lacomba, Doctor

Role: STUDY_DIRECTOR

Universidad Alcala

Other Identifiers

IDLR1985

Identifier Type: -

Identifier Source: org_study_id