HyperalgesiaEarly Phase 1NMNCT02011477
Hypoalgesic Effects Neural Mobilization Techniques
A Early Phase 1 study testing Neural Glide and Neural stretching in people with Hyperalgesia, run by Josue Fernandez Carnero at 1 site in Spain.
Trial summary
The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- Neural Glide and Neural stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Nov 2013
- Phase
- Early Phase 1
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.
Who cannot join
- rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.
- development of systemic or degenerative diseases
- subjects with symptoms of depression according Beck's questionnaire
- pain in any area between the lower back and head in the last 9 months
- traumatic event in the past 12 months
- history of neck or face pain in the last 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro superior de Estudios Universitarios La Salle
Madrid, Aravaca, 28023
About this study
Official title: Comparison of Hypoalgesic Effects of Neural Stretching Versus Neural Gliding: a Randomized Clinical Trial
The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.
Read the detailed description
Asymptomatic subjects will be randomly allocated into three groups: the neural glide group; the neural stretch group; and the placebo group. Each subject will receive one treatment session. Outcome measures included bilateral pressure pain threshold measured at the trigeminal, cervical, and tibialis anterior points, which will assess pre-treatment and immediately post-treatment by a blinded assessor. Three-way repeated measures analysis of variance was used to evaluate changes in pressure pain threshold, with group (experimental or control) as the between-subjects variable and time (pre-, post-treatment) or side (dominant, nondominant) as the within-subjects variable.
- Conditions
- Hyperalgesia
- Being tested
- Neural Glide, Neural stretching
- Keywords
- Neural mobilization, Physical therapy, Asymptomatic subjects
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural GlideOther
This technique involves two movements, throughout several joints to glide the nerves. The subject sit on a couch with the right lower limb extended and the left lower limb flexed. The therapist will take the subject's head by putting his hands on the suboccipital and front region. In the initial movement, performe craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject performed dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as performing plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject
Neural stretchingOther
In the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. The therapist was on the subject´s side, with his knee below the subject's head, bringing stability. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject
| Study group | Role | What they receive |
|---|---|---|
| Neural glide | Experimental | This technique involves two movements, initial and final. It consists of going from one to the other constantly. The therapist took the subject's head by putting his hands on the suboccipital and front region. In the initial movement, the therapist perform craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject perform dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as perform plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject. The session lasted 7 minutes. Receives: Other: Neural stretching |
| Placebo | Placebo comparator | The model of the ultrasound (ENRAF-NONIUS, P.O. Box 12080, 3004 GB Rotterdam, The Netherlands). The subject was placed in a prone position, with arms along the body and the head in the hole of the examining couch. The therapist applied a non-therapeutic dose of ultrasound for 7 minutes with no break all over the cervical area and trapezius, in circles. Receives: Other: Neural Glide; Other: Neural stretching |
| Neural Stretching | Active comparator | In the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject . In the final position, the therapist made the subject execute a craniocervical flexion while he pushed the subject's hands against the chest, in order to increase thoracic kyphosis. At the same time, the subject had to raise the elevated leg without separating the popliteal zone in the other knee, while maintaining dorsiflexion of the ankle and a maximum knee extension. The session lasted 7 minutes. Receives: Other: Neural Glide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold assessment
The pressure pain threshold (PPT) is defined as the amount of pressure at which the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA) consisting of a rubber head (1 cm2) attached to a pressure gauge was used to measure PPTs. Force was measured in kilograms (kg); therefore, thresholds were expressed in kg/cm2. The protocol will use a sequence of three measurements, with an interval of 30 seconds between them. PPT will assess over bilateral masseter points 1 and 2, the temporalis muscles, the suboccipital muscle, the upper trapezius muscle (midway between C7 and the acromion), and the tibialis anterior muscle (upper third of the muscle belly) by an assessor blinded to the subject's condition.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Hector Beltran, MSc, Principal investigator, Centro de estudios La Salle. Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011477
- Sponsor's protocol ID
- CSEULS-PI-001/2013
- Acronym
- NM
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hypoalgesic Effects of Neural Stretching Versus Neural Gliding: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02011477
- Acronym / sponsor ID
- NM / CSEULS-PI-001/2013
- Conditions
- Hyperalgesia
- Keywords
- Neural mobilization, Physical therapy, Asymptomatic subjects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Dec 2013 (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 purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.
Detailed description
Asymptomatic subjects will be randomly allocated into three groups: the neural glide group; the neural stretch group; and the placebo group. Each subject will receive one treatment session. Outcome measures included bilateral pressure pain threshold measured at the trigeminal, cervical, and tibialis anterior points, which will assess pre-treatment and immediately post-treatment by a blinded assessor. Three-way repeated measures analysis of variance was used to evaluate changes in pressure pain threshold, with group (experimental or control) as the between-subjects variable and time (pre-, post-treatment) or side (dominant, nondominant) as the within-subjects variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neural glide | Experimental | Other: Neural stretchingThis technique involves two movements, initial and final. It consists of going from one to the other constantly. The therapist took the subject's head by putting his hands on the suboccipital and front region. In the initial movement, the therapist perform craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject perform dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as perform plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject. The session lasted 7 minutes. |
| Placebo | Placebo comparator | Other: Neural Glide, Other: Neural stretchingThe model of the ultrasound (ENRAF-NONIUS, P.O. Box 12080, 3004 GB Rotterdam, The Netherlands). The subject was placed in a prone position, with arms along the body and the head in the hole of the examining couch. The therapist applied a non-therapeutic dose of ultrasound for 7 minutes with no break all over the cervical area and trapezius, in circles. |
| Neural Stretching | Active comparator | Other: Neural GlideIn the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject . In the final position, the therapist made the subject execute a craniocervical flexion while he pushed the subject's hands against the chest, in order to increase thoracic kyphosis. At the same time, the subject had to raise the elevated leg without separating the popliteal zone in the other knee, while maintaining dorsiflexion of the ankle and a maximum knee extension. The session lasted 7 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.
Key exclusion criteria (6 listed)
- rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.
- development of systemic or degenerative diseases
- subjects with symptoms of depression according Beck's questionnaire
- pain in any area between the lower back and head in the last 9 months
- traumatic event in the past 12 months
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 |
|---|---|---|
| Neural GlideThis technique involves two movements, throughout several joints to glide the nerves. The subject sit on a couch with the right lower limb extended and the left lower limb flexed. The therapist will take the subject's head by putting his hands on the suboccipital and front region. In the initial movement, performe craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject performed dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as performing plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject | Other | Neural Stretching, Placebo |
| Neural stretchingIn the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. The therapist was on the subject´s side, with his knee below the subject's head, bringing stability. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject | Other | Neural glide, Placebo |
Primary outcome
Pressure pain threshold assessment
Time frame: 5 minutes
The pressure pain threshold (PPT) is defined as the amount of pressure at which the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA) consisting of a rubber head (1 cm2) attached to a pressure gauge was used to measure PPTs. Force was measured in kilograms (kg); therefore, thresholds were expressed in kg/cm2. The protocol will use a sequence of three measurements, with an interval of 30 seconds between them. PPT will assess over bilateral masseter points 1 and 2, the temporalis muscles, the suboccipital muscle, the upper trapezius muscle (midway between C7 and the acromion), and the tibialis anterior muscle (upper third of the muscle belly) by an assessor blinded to the subject's condition.
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 13 Dec 2013.
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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.
Hector Beltran, MSc principal investigator
Centro de estudios La Salle. Universidad Autonoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neural Glide and Neural stretching in people with Hyperalgesia, run by Josue Fernandez Carnero 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 1 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 13 Dec 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 assessment (time frame: 5 minutes). 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 13 Dec 2013.