Neck PainNCT02890394
Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain
A study testing Suboccipital inhibition technique in people with Neck Pain and Myofascial Pain, run by University of Alcala.
Trial summary
The project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Myofascial Pain
- What is being tested?
- Suboccipital inhibition technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of full age .
- ≥ 15/50 rating in the Neck Disability Index
- Participants with good adhesion to the study .
- Participants who have signed informed after appropriate informed consent.
Who cannot join
- Cancer , inflammatory , infectious , vascular , neurological and metabolic processes.
- Patients who are under medical treatment.
- Patients with psychiatric illnesses.
- Women : pregnancy.
- Patients who have not signed the informed consent.
About this study
Official title: Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain: a Pilot Study
The project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In this technique the investigator would be carrying out the relaxation of the suboccipital muscles: lower rectus capitis posterior, superior oblique head straight back and head higher. It is a technique used very often but without knowledge about the time needed for implementation. In several studies that have used the technique it has been maintained for 2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three groups formed by patients with mechanical neck pain that they applied the technique two, four or ten minutes and a control group of patients with mechanical neck pain. The four groups were measured before and after treatment the pain threshold to pressure by algometer and conduct the test repositioning of the head to show any changes after application of the technique.
- Conditions
- Neck Pain, Myofascial Pain
- Being tested
- Suboccipital inhibition technique
- Keywords
- Neck Pain, Suboccipital inhibition, Physical Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital inhibition techniqueOther
Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull
| Study group | Role | What they receive |
|---|---|---|
| 2 minutes Group | Experimental | The group was perform the technique inhibition suboccipital two minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. Receives: Other: Suboccipital inhibition technique |
| 4 minutes Group | Experimental | The group was perform the technique inhibition suboccipital four minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. Receives: Other: Suboccipital inhibition technique |
| 8 minutes Group | Experimental | The group was perform the technique inhibition suboccipital eight minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. Receives: Other: Suboccipital inhibition technique |
| not intervention Group | No intervention | The not intervention group will be asked to lie supine on the table for ten minutes, collecting data by measuring with algometer and test repositioning of the head before and after laying. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pain threshold pressure after ten minutes from the suboccipital inhibition
Three measurements were performed with a rest period of 30 seconds between each measurement.
Measured: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
Change from repositioning of the head after ten minutes from the suboccipital inhibition
a target is placed on the wall in front of the subject at a distance of 90 cm and adjusted to align with the reference position of the head. a helmet with a laser on top is used. For each test subjects will be instructed to memorize the initial reference position by carrying out a maximum cervical rotation and returning to the reference position without speed limit. Subjects undertake 10 trials. Before each test, the examiner manually reposition the subject's head to the reference position. Once the subject is instructed to conduct the test measurement.
Measured: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionSep 2016 (estimated)
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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Sánchez Tejada, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890394
- Sponsor's protocol ID
- UAH
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT02890394
- Acronym / sponsor ID
- UAH
- Conditions
- Neck Pain, Myofascial Pain
- Keywords
- Neck Pain, Suboccipital inhibition, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 7 Sep 2016 (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.
The project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In this technique the investigator would be carrying out the relaxation of the suboccipital muscles: lower rectus capitis posterior, superior oblique head straight back and head higher. It is a technique used very often but without knowledge about the time needed for implementation. In several studies that have used the technique it has been maintained for 2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three groups formed by patients with mechanical neck pain that they applied the technique two, four or ten minutes and a control group of patients with mechanical neck pain. The four groups were measured before and after treatment the pain threshold to pressure by algometer and conduct the test repositioning of the head to show any changes after application of the technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 minutes Group | Experimental | Other: Suboccipital inhibition techniqueThe group was perform the technique inhibition suboccipital two minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. |
| 4 minutes Group | Experimental | Other: Suboccipital inhibition techniqueThe group was perform the technique inhibition suboccipital four minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. |
| 8 minutes Group | Experimental | Other: Suboccipital inhibition techniqueThe group was perform the technique inhibition suboccipital eight minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique. |
| not intervention Group | No intervention | –The not intervention group will be asked to lie supine on the table for ten minutes, collecting data by measuring with algometer and test repositioning of the head before and after laying. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women of full age .
- ≥ 15/50 rating in the Neck Disability Index
- Participants with good adhesion to the study .
- Participants who have signed informed after appropriate informed consent.
Key exclusion criteria (5 listed)
- Cancer , inflammatory , infectious , vascular , neurological and metabolic processes.
- Patients who are under medical treatment.
- Patients with psychiatric illnesses.
- Women : pregnancy.
- Patients who have not signed the informed consent.
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 |
|---|---|---|
| Suboccipital inhibition techniqueSuboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull | Other | 2 minutes Group, 4 minutes Group, 8 minutes Group |
Primary outcome
Change from pain threshold pressure after ten minutes from the suboccipital inhibition
Time frame: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
Three measurements were performed with a rest period of 30 seconds between each measurement.
Change from repositioning of the head after ten minutes from the suboccipital inhibition
Time frame: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
a target is placed on the wall in front of the subject at a distance of 90 cm and adjusted to align with the reference position of the head. a helmet with a laser on top is used. For each test subjects will be instructed to memorize the initial reference position by carrying out a maximum cervical rotation and returning to the reference position without speed limit. Subjects undertake 10 trials. Before each test, the examiner manually reposition the subject's head to the reference position. Once the subject is instructed to conduct the test measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibition technique in people with Neck Pain and Myofascial Pain, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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?
Results are not available in the source record.
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?
Change from pain threshold pressure after ten minutes from the suboccipital inhibition (time frame: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured). The study lists 2 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 7 Sep 2016.