Neck PainNCT03902119
INYBI Tool in Chronic Neck Pain
A study testing INYBI tool and Manual suboccipital inhibition in people with Neck Pain, run by University of Seville at 1 site in Spain.
Trial summary
Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the suboccipital muscles compared with the use of the so-called INYBI tool in individuals with chronic non-specific neck pain, and the compare the results of using both approaches on pain relief, cervical range of motion neck and… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- INYBI tool and Manual suboccipital inhibition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2019to 27 Sep 2019
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of non-specific mechanical neck pain.
- Pain of more than 3 months of duration.
- Pain between the occiput and the third dorsal vertebra.
- Willingness to participate in the treatment and in the follow-up measurements
- Neck pain reproduced by neck movements or palpation
Who cannot join
- Cognitive impairment or inability to communicate.
- Having received manual therapy in the last two months before recruitment.
- Having received anti-inflammatory treatment, antidepressants or muscle relaxants in the last 72 hours.
- Any contraindication to treatment or evaluation procedures.
- Diagnosis of systemic diseases
- Diagnosis of fibromyalgia
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- Pregnancy
- Signs of spinal nerve root compression
- Previous whiplash
- Any diagnosed possible cause for their neck pain (infection, cancer, spinal stenosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the suboccipital muscles compared with the use of the so-called INYBI tool in individuals with chronic non-specific neck pain, and the compare the results of using both approaches on pain relief, cervical range of motion neck and vertical maximum mouth opening.
Design: Quantitative, experimental, longitudinal, prospective, and double blinded study.
Read more
Subjects: Patients between 18 and 40 years, with chronic non-specific neck pain of at least 3 months of evolution.
Methods: The experimental group will undergo a 5 minutes intervention for the suboccipital muscles using the INYBI tool. The control group will receive a 5 minutes of treatment involving the suboccipital muscles manual inhibition technique.
- Conditions
- Neck Pain
- Being tested
- INYBI tool, Manual suboccipital inhibition
- Keywords
- neck pain, randomized control trial, manual therapy, physical therapy, suboccipital inhibition
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INYBI toolDevice
Patients will lie down in supine position so that the INYBI tool will contact the suboccipital muscles at the posterior arch of the atlas. The therapist will adapt the height of the tool for each individual. All patients will use the softest head of the device. A 50Hz vibration speed will be set sup during 5 minutes.
Manual suboccipital inhibitionOther
Patients will lie down in supine position.The therapist will be seated at the head of the treatment table. The therapist will keep the metacarpophalangeal joints in a flexed position, while therapists fingertips of both hands will contact with the suboccipital muscles at the posterior arch of the atlas.
| Study group | Role | What they receive |
|---|---|---|
| INIBY tool | Experimental | Patients will undergo a single treatment session consisting of applying a suboccipital muscle inhibition technique using the so-called INYBI tool. The treatment session will last approximately 5 minutes Receives: Device: INYBI tool |
| Manual suboccipital inhibition | Active comparator | Patients will receive a single treatment session consisting of the use of the manual suboccipital muscles inhibition technique.The treatment session will last approximately 5 minutes Receives: Other: Manual suboccipital inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Measured: From baseline to immediately after treatment.
Active cervical range of movement (ROM). The range of movement will be assessed in degrees
Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer.
Measured: From baseline to immediately after treatment.
Pain free vertical mouth opening. This outcome will be evaluated in centimeters.
Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41.
Measured: From baseline to immediately after treatment.
Atlas rotation ROM, assessed in degrees
The atlas bone left and right rotation ROM will be assessed using the flexion-rotation test. For this test, with the participant in supine position, the maximum mobility in head rotation while keeping maximum passive neck flexion will be assessed
Measured: From baseline to immediately after treatment.
Self-reported pain intensity
Self-perceived pain intensity will be evaluated during all active cervical movements by a 0 to 10 Visual Analogue Scale (VAS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain
Measured: From baseline to immediately after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start24 Apr 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Alberto Heredia-Rizo, PhD, Study director, Physiotherapy Department, University of Sevilla, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902119
- Sponsor's protocol ID
- INYBI tool
- Status last verified
- Oct 2019
- First submitted
- 27 Mar 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
- ClinicalTrials.gov ID
- NCT03902119
- Acronym / sponsor ID
- INYBI tool
- Conditions
- Neck Pain
- Keywords
- neck pain, randomized control trial, manual therapy, physical therapy, suboccipital inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 3 Apr 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.
Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the suboccipital muscles compared with the use of the so-called INYBI tool in individuals with chronic non-specific neck pain, and the compare the results of using both approaches on pain relief, cervical range of motion neck and vertical maximum mouth opening.
Design: Quantitative, experimental, longitudinal, prospective, and double blinded study.
Subjects: Patients between 18 and 40 years, with chronic non-specific neck pain of at least 3 months of evolution.
Methods: The experimental group will undergo a 5 minutes intervention for the suboccipital muscles using the INYBI tool. The control group will receive a 5 minutes of treatment involving the suboccipital muscles manual inhibition technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INIBY tool | Experimental | Device: INYBI toolPatients will undergo a single treatment session consisting of applying a suboccipital muscle inhibition technique using the so-called INYBI tool. The treatment session will last approximately 5 minutes |
| Manual suboccipital inhibition | Active comparator | Other: Manual suboccipital inhibitionPatients will receive a single treatment session consisting of the use of the manual suboccipital muscles inhibition technique.The treatment session will last approximately 5 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of non-specific mechanical neck pain.
- Pain of more than 3 months of duration.
- Pain between the occiput and the third dorsal vertebra.
- Willingness to participate in the treatment and in the follow-up measurements
- Neck pain reproduced by neck movements or palpation
Key exclusion criteria (10 listed)
- Cognitive impairment or inability to communicate.
- Having received manual therapy in the last two months before recruitment.
- Having received anti-inflammatory treatment, antidepressants or muscle relaxants in the last 72 hours.
- Any contraindication to treatment or evaluation procedures.
- Diagnosis of systemic diseases
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 |
|---|---|---|
| INYBI toolPatients will lie down in supine position so that the INYBI tool will contact the suboccipital muscles at the posterior arch of the atlas. The therapist will adapt the height of the tool for each individual. All patients will use the softest head of the device. A 50Hz vibration speed will be set sup during 5 minutes. | Device | INIBY tool |
| Manual suboccipital inhibitionPatients will lie down in supine position.The therapist will be seated at the head of the treatment table. The therapist will keep the metacarpophalangeal joints in a flexed position, while therapists fingertips of both hands will contact with the suboccipital muscles at the posterior arch of the atlas. | Other | Manual suboccipital inhibition |
Primary outcome
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
Time frame: From baseline to immediately after treatment.
PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Active cervical range of movement (ROM). The range of movement will be assessed in degrees
Time frame: From baseline to immediately after treatment.
Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer.
Pain free vertical mouth opening. This outcome will be evaluated in centimeters.
Time frame: From baseline to immediately after treatment.
Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41.
Atlas rotation ROM, assessed in degrees
Time frame: From baseline to immediately after treatment.
The atlas bone left and right rotation ROM will be assessed using the flexion-rotation test. For this test, with the participant in supine position, the maximum mobility in head rotation while keeping maximum passive neck flexion will be assessed
Self-reported pain intensity
Time frame: From baseline to immediately after treatment.
Self-perceived pain intensity will be evaluated during all active cervical movements by a 0 to 10 Visual Analogue Scale (VAS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain
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 29 Oct 2019.
- 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.
Alberto Heredia-Rizo, PhD study director
Physiotherapy Department, University of Sevilla, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INYBI tool and Manual suboccipital inhibition in people with Neck Pain, run by University of Seville 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 5 inclusion and 10 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 29 Oct 2019. 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. 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?
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2 (time frame: From baseline to immediately after treatment.). The study lists 5 primary outcomes in all. 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 29 Oct 2019.