Back to resultsHypoalgesic Effects Neural Mobilization Techniques (NM)
Primary Purpose
Hyperalgesia
Status
Completed
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Neural Glide
Neural stretching
Sponsored by
About this trial
This is an interventional treatment trial for Hyperalgesia focused on measuring Neural mobilization, Physical therapy, Asymptomatic subjects
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.
Exclusion Criteria:
- 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
Sites / Locations
- Centro superior de Estudios Universitarios La Salle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Neural glide
Placebo
Neural Stretching
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02011477
First Posted
December 2, 2013
Last Updated
December 9, 2013
Sponsor
Josue Fernandez Carnero
Collaborators
Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02011477
Brief Title
Hypoalgesic Effects Neural Mobilization Techniques
Acronym
NM
Official Title
Comparison of Hypoalgesic Effects of Neural Stretching Versus Neural Gliding: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero
Collaborators
Universidad Autonoma de Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
Neural mobilization, Physical therapy, Asymptomatic subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neural glide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Neural Stretching
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neural Glide
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Neural stretching
Intervention Description
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
Primary Outcome Measure Information:
Title
Pressure pain threshold assessment
Description
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.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector Beltran, MSc
Organizational Affiliation
Centro de estudios La Salle. Universidad Autonoma de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro superior de Estudios Universitarios La Salle
City
Madrid
State/Province
Aravaca
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
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Hypoalgesic Effects Neural Mobilization Techniques
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