EMG at Performing ULTN 1 in Breast Cancer Patients

NCT02599467 | Completed DMC

• 1 other identifier: IDLR1985
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physiotherapy

Keywords

Nerve Pain; Electromyography; Median Nerve; Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Increased evoked EMG muscle activity

  Intensity of the evoked muscle activity from biceps brachii and triceps brachii muscles by EMG recording

  5 min

Secondary Outcomes (1)

• Upper limb range of motion restrictions

  15 min

Study Arms (3)

case group 1: ALND

EXPERIMENTAL

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.

Other: ULNT 1 and EMG recording

case group 2: SLNB

EXPERIMENTAL

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

Other: ULNT 1 and EMG recording

control group

ACTIVE COMPARATOR

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.

Other: ULNT 1 and EMG recording

Interventions

ULNT 1 and EMG recording 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 1: ALND; case group 2: SLNB; control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

MeSH Terms

Conditions

Neuralgia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• María Torres-Lacomba, Doctor

  Universidad Alcala

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: November 6, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11