- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599467
EMG at Performing ULTN 1 in Breast Cancer Patients
Evoked EMG Muscle Activity at Performing ULTN 1 in Breast Cancer Patients
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
|
Experimental: 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 |
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.
|
Active Comparator: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased evoked EMG muscle activity
Time Frame: 5 min
|
Intensity of the evoked muscle activity from biceps brachii and triceps brachii muscles by EMG recording
|
5 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper limb range of motion restrictions
Time Frame: 15 min
|
degrees of range of motion of three movements: shoulder abduction, shoulder external rotation and elbow flexion.
|
15 min
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: María Torres-Lacomba, Doctor, Universidad Alcala
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IDLR1985
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