Neck PainULNT1NCT04168476
Effectiveness of Scapula Mobilization on Mechanosensitivity of Upper Limb Neural Test 1 in Mechanical Neck Pain
A study testing Interscapular muscle release or scapular mobilization technique as described by Travell and Simons. and Calcaneus abduction and adduction mobilization technique in people with Neck Pain and Musculoskeletal Diseases, run by Aitor Vaquero Garrido at 1 site in Spain.
Trial summary
Between 45% and 70% of the general population suffers neck pain at some point in their lives, making it one of the most frequent reasons for taking sick leave. Given its importance in physiotherapy at clinical level, we seek to observe how a scapular mobilization technique might influence the neural mechanosensitivity… Read more about this study
- Who is it for?
- Ages 22 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Musculoskeletal Diseases
- What is being tested?
- Interscapular muscle release or scapular mobilization technique as described by Travell and Simons. and Calcaneus abduction and adduction mobilization technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 27 Feb 2020
- 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 22 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with mechanical cervicalgia and a positive median neurodynamic test (ULNT1) reproducing the patient's cervical pain.
- Sign the informed consent.
Who cannot join
- Do not sign informed consent.
- Patients who, due to previous malformations or injuries, are not able to be positioned in the position described for the ULNT1 test.
- Congenital malformations of the cervical spine and / or upper limb.
- Previous spine surgery.
- Neurological pathologies diagnosed, such as diabetic polyneuritis or others.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Scapula Mobilization Technique on Neural Mechanosensitivity of Upper Limb Neural Test 1 (ULNT1) in Subjects With Mechanical Neck Pain
Between 45% and 70% of the general population suffers neck pain at some point in their lives, making it one of the most frequent reasons for taking sick leave. Given its importance in physiotherapy at clinical level, we seek to observe how a scapular mobilization technique might influence the neural mechanosensitivity of the median nerve as measured by Upper Limb Neural Test 1 (ULNT1) on subjects with neck pain.
Hypotheses and objectives. Performing a scapular mobilization technique on subjects with neck pain and a positive ULNT1 improves the patient's response to said test. It also decreases the patient's neck pain as measured using a Visual Analog Scale (VAS) for pain and increases grip strength.
Material and method. A single-blind clinical trial was performed on subjects randomly assigned to either a treatment group or control group. The sample consisted of 60 subjects (N = 60) -30 in the treatment group (n = 30) and the other 30 as a control (n = 30) -and was made up of patients with neck pain and a positive ULNT1. A scapular mobilization was performed on the first group and on the second, a calcaneus abduction adduction on the opposite side from the positive ULNT1 as a placebo.
Read the detailed description
Mechanical cervicalgia is a very frequent and important clinical picture in physiotherapy consultations. It can be considered as a pluripatology as it covers somatic, functional, psychological and social aspects. This ailment is suffered by between 45 and 70% of the general population during some period of life and is one of the most frequent justifications of work leave and the main cause of permanent disability. Mechanical cervicalgia significantly decreases the quality of life of those who suffer from it: it frequently produces a significant disability when generating pain, functional deficit, headaches, movement restriction, vertiginous syndromes, nausea and / or vomiting, etc. This leads to reduced work time and increased health system costs, causing a strong economic and social impact. For example, Borghouts JA and Cols point out that in the Netherlands in 1996 these costs were approximately 686 million dollars, which constituted 1% of total health expenditure and 0.1% of its Gross Domestic Product (GDP) . In Spain, referrals to the cervicalgia physiotherapy service represent 10% of the total of all health demands; in Britain this percentage reaches 15% and in Canada 30%. Likewise, it should be considered that the direct cost caused by cervicalgia to the health system in our country, specifically to the Primary Care consultation, constitutes 2% of the total, and in some centers this figure reaches up to 12% if they are considered diagnostic tests, pharmaceutical expenses and visits to the specialist.
- Conditions
- Neck Pain, Musculoskeletal Diseases
- Being tested
- Interscapular muscle release or scapular mobilization technique as described by Travell and Simons., Calcaneus abduction and adduction mobilization technique
- Keywords
- Median Nerve, Hand Strength, Brachial plexus, Physical Therapy Modalities, Neck Pain
- Medical subject headings
- Neck Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.Other
Patient is sidelying with the testing side up. The auditor stands in front of the patient, reaches over the patient's shoulder to grasp the upper portion of the vertebral border of the scapula, and the other arm reaches under the patient's humerus to grasp the lower portion of the vertebral border of the scapula.
The auditor then slowly moves the scapula into elevation/depression, internal/external rotation/abduction and adduction.
To standardize the technique and be able to reproduce it in each participant, a set of 10 repetitions for each movement was performed in the same order.
Calcaneus abduction and adduction mobilization techniqueOther
Abduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables:
* Visual Analogue Scale
* Range of movement
* Hand grip strength. After a first assessment, scapula mobilization techniques were performed and participants reassessed. Receives: Other: Interscapular muscle release or scapular mobilization technique as described by Travell and Simons. |
| Control group | Placebo comparator | Participants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables:
* Visual Analogue Scale
* Range of movement
* Hand grip strength. The procedure was a contralateral calcaneus abduction and adduction mobilization technique was carried out. Receives: Other: Calcaneus abduction and adduction mobilization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer Test
The axis of the Goniometer is placed On the elbow joint. The stationary arm is lined up with the arm and the moveable arm along the forearm. The subject is asked to perform elbow extension and the angle is measured.
Improvement of this angle 10º. Inmediately after the intervention
Measured: Two minutes
Secondary outcomes (1)
Neck pain
Improvement of this 0,5 Newtons. Using a visual pain scale, with values between 0 and 10, the subject marks the intensity level of the neck pain. Inmediately after the intervention
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Jan 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aitor Vaquero Garrido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aitor Vaquero Garrido, University of Seville
- Investigators
- Aitor Vaquero Garrido, Study chair, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168476
- Sponsor's protocol ID
- Upper Limb Neural Test 1
- Acronym
- ULNT1
- Status last verified
- Oct 2020
- First submitted
- 15 Nov 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macias CH, Ortega JR, Serrano-Sanchez FJ, Diaz-Mancha JA, Fernandez Seguin L, Cabanes-Garcia J. Effectiveness of the scapula mobilization technique on the neural mechanosensitivity of the upper limb neural test 1 in individuals with mechanical cervicalgia. A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:1926-1931. doi: 10.1016/j.jbmt.2024.10.006. Epub 2024 Oct 11.
PubMed 39593546
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Scapula Mobilization Technique on Neural Mechanosensitivity of Upper Limb Neural Test 1 (ULNT1) in Subjects With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT04168476
- Acronym / sponsor ID
- ULNT1 / Upper Limb Neural Test 1
- Conditions
- Neck Pain, Musculoskeletal Diseases
- Keywords
- Median Nerve, Hand Strength, Brachial plexus, Physical Therapy Modalities, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aitor Vaquero GarridoUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- 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.
Between 45% and 70% of the general population suffers neck pain at some point in their lives, making it one of the most frequent reasons for taking sick leave. Given its importance in physiotherapy at clinical level, we seek to observe how a scapular mobilization technique might influence the neural mechanosensitivity of the median nerve as measured by Upper Limb Neural Test 1 (ULNT1) on subjects with neck pain.
Hypotheses and objectives. Performing a scapular mobilization technique on subjects with neck pain and a positive ULNT1 improves the patient's response to said test. It also decreases the patient's neck pain as measured using a Visual Analog Scale (VAS) for pain and increases grip strength.
Material and method. A single-blind clinical trial was performed on subjects randomly assigned to either a treatment group or control group. The sample consisted of 60 subjects (N = 60) -30 in the treatment group (n = 30) and the other 30 as a control (n = 30) -and was made up of patients with neck pain and a positive ULNT1. A scapular mobilization was performed on the first group and on the second, a calcaneus abduction adduction on the opposite side from the positive ULNT1 as a placebo.
Detailed description
Mechanical cervicalgia is a very frequent and important clinical picture in physiotherapy consultations. It can be considered as a pluripatology as it covers somatic, functional, psychological and social aspects. This ailment is suffered by between 45 and 70% of the general population during some period of life and is one of the most frequent justifications of work leave and the main cause of permanent disability. Mechanical cervicalgia significantly decreases the quality of life of those who suffer from it: it frequently produces a significant disability when generating pain, functional deficit, headaches, movement restriction, vertiginous syndromes, nausea and / or vomiting, etc. This leads to reduced work time and increased health system costs, causing a strong economic and social impact. For example, Borghouts JA and Cols point out that in the Netherlands in 1996 these costs were approximately 686 million dollars, which constituted 1% of total health expenditure and 0.1% of its Gross Domestic Product (GDP) . In Spain, referrals to the cervicalgia physiotherapy service represent 10% of the total of all health demands; in Britain this percentage reaches 15% and in Canada 30%. Likewise, it should be considered that the direct cost caused by cervicalgia to the health system in our country, specifically to the Primary Care consultation, constitutes 2% of the total, and in some centers this figure reaches up to 12% if they are considered diagnostic tests, pharmaceutical expenses and visits to the specialist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized prospective controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.Participants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables: * Visual Analogue Scale * Range of movement * Hand grip strength. After a first assessment, scapula mobilization techniques were performed and participants reassessed. |
| Control group | Placebo comparator | Other: Calcaneus abduction and adduction mobilization techniqueParticipants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables: * Visual Analogue Scale * Range of movement * Hand grip strength. The procedure was a contralateral calcaneus abduction and adduction mobilization technique was carried out. |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with mechanical cervicalgia and a positive median neurodynamic test (ULNT1) reproducing the patient's cervical pain.
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Do not sign informed consent.
- Patients who, due to previous malformations or injuries, are not able to be positioned in the position described for the ULNT1 test.
- Congenital malformations of the cervical spine and / or upper limb.
- Previous spine surgery.
- Neurological pathologies diagnosed, such as diabetic polyneuritis or others.
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 |
|---|---|---|
| Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.Patient is sidelying with the testing side up. The auditor stands in front of the patient, reaches over the patient's shoulder to grasp the upper portion of the vertebral border of the scapula, and the other arm reaches under the patient's humerus to grasp the lower portion of the vertebral border of the scapula. The auditor then slowly moves the scapula into elevation/depression, internal/external rotation/abduction and adduction. To standardize the technique and be able to reproduce it in each participant, a set of 10 repetitions for each movement was performed in the same order. | Other | Treatment group |
| Calcaneus abduction and adduction mobilization techniqueAbduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured. | Other | Control group |
Primary outcome
Goniometer Test
Time frame: Two minutes
The axis of the Goniometer is placed On the elbow joint. The stationary arm is lined up with the arm and the moveable arm along the forearm. The subject is asked to perform elbow extension and the angle is measured. Improvement of this angle 10º. Inmediately after the intervention
1 secondary outcome
Neck pain
Time frame: Two minutes
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 19 Oct 2020.
- Derived from this study: PubMed 39593546Macias CH, Ortega JR, Serrano-Sanchez FJ, Diaz-Mancha JA, Fernandez Seguin L, Cabanes-Garcia J. Effectiveness of the scapula mobilization technique on the neural mechanosensitivity of the upper limb neural test 1 in individuals with mechanical cervicalgia. A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:1926-1931. doi: 10.1016/j.jbmt.2024.10.006. Epub 2024 Oct 11.
- Individual participant dataSharing planned: No
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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.
Aitor Vaquero Garrido study chair
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscapular muscle release or scapular mobilization technique as described by Travell and Simons. and Calcaneus abduction and adduction mobilization technique in people with Neck Pain and Musculoskeletal Diseases, run by Aitor Vaquero Garrido at 1 site in Spain.
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 6 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Goniometer Test (time frame: Two minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168476, which also lists 1 linked publication.
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 19 Oct 2020.