PhysiotherapyNCT02599467
EMG at Performing ULTN 1 in Breast Cancer Patients
A study testing ULNT 1 and EMG recording in people with Physiotherapy, run by University of Alcala.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physiotherapy
- What is being tested?
- ULNT 1 and EMG recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No undergo breast cancer.
- To be the age and the sema dominant arm than one of the cases.
Who cannot join
- Current painful conditions involving their neck or dominant upper-extremity.
- Chronic pain conditions (i.e. Fibromyalgia).
- Current use of pain relievers.
About this study
Official title: Evoked EMG Muscle Activity at Performing ULTN 1 in Breast Cancer Patients
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.
Read the 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
- Being tested
- ULNT 1 and EMG recording
- Keywords
- Nerve Pain, Electromyography, Median Nerve, Breast Neoplasms
- Medical subject headings
- Neuralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULNT 1 and EMG recordingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: ULNT 1 and EMG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased evoked EMG muscle activity
Intensity of the evoked muscle activity from biceps brachii and triceps brachii muscles by EMG recording
Measured: 5 min
Secondary outcomes (1)
Upper limb range of motion restrictions
degrees of range of motion of three movements: shoulder abduction, shoulder external rotation and elbow flexion.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRENE DE LA ROSA DÍAZ, University of Alcala
- Investigators
- María Torres-Lacomba, Doctor, Study director, Universidad Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599467
- Sponsor's protocol ID
- IDLR1985
- Status last verified
- Nov 2015
- First submitted
- 15 Sep 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evoked EMG Muscle Activity at Performing ULTN 1 in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02599467
- Acronym / sponsor ID
- IDLR1985
- Conditions
- Physiotherapy
- Keywords
- Nerve Pain, Electromyography, Median Nerve, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case group 1: ALND | Experimental | Other: ULNT 1 and EMG recordingInclusion 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. |
| case group 2: SLNB | Experimental | Other: ULNT 1 and EMG recordingInclusion 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 |
| control group | Active comparator | Other: ULNT 1 and EMG recordingMatched 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No undergo breast cancer.
- To be the age and the sema dominant arm than one of the cases.
Key exclusion criteria (3 listed)
- Current painful conditions involving their neck or dominant upper-extremity.
- Chronic pain conditions (i.e. Fibromyalgia).
- Current use of pain relievers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULNT 1 and EMG recordingWhile 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. | Other | case group 1: ALND, case group 2: SLNB, control group |
Primary outcome
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
1 secondary outcome
Upper limb range of motion restrictions
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Torres-Lacomba, Doctor study director
Universidad Alcala
Questions about this trial
What is this clinical trial studying?
A study testing ULNT 1 and EMG recording in people with Physiotherapy, run by University of Alcala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased evoked EMG muscle activity (time frame: 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.