Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
Primary Purpose
Pain, Pain, Neuropathic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurodynamic Slider Mobilization
Neurodynamic Tensioner Mobilization
Sham Neurodynamic Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring neurodynamics, neurodynamic mobilization, quantitative sensory testing, median nerve, pressure pain threshold, thermal pain threshold, thermal pain tolerance
Eligibility Criteria
Inclusion Criteria:
- Age: 18-65
- Ability to speak and comprehend English.
Exclusion Criteria:
- Current neck or upper extremity symptoms
- Disorders that could result in impaired sensation - such as diabetes.
- Current use of prescription pain medication or other medications that could result in altered pain perception - such as anti-anxiety medications or anti-depressants.
- History of any chronic painful condition
- Diagnosis of any major psychiatric disorder
- Current pregnancy
- Any painful condition within the past 3 months for which care was sought
Sites / Locations
- Brenau University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Neurodynamic Slider Mobilization
Neurodynamic Tensioner Mobilization
Sham Neurodynamic Mobilization
Arm Description
Outcomes
Primary Outcome Measures
Pressure Pain Threshold (PPT)
PPT will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior using a pressure algometer with an affixed 1cm2 rubber tip.
Thermal Pain Threshold (TPT)
TPT will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.
Thermal Pain Tolerance (TPTol)
TPTol will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.
Elbow Extension ROM Obtained on Neurodynamic Testing
A neurodynamic test of the median nerve will be performed according to the ULNT1 procedure originally described by David Butler. Degrees of elbow extension will then be recorded using a universal goniometer, and each subject will rate each of the following 5 sensory descriptors on a 10 cm Visual Analog Scale (VAS): "Stinging", "Tingling", "Tightness", "Sharpness", and "Numbness". The average of the 5 sensory descriptor ratings will then be averaged to create a single sensory descriptor VAS score - as outlined in Beneciuk et al 2009.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03674489
Brief Title
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
Official Title
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brenau University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background & Significance Pain is the primary reason many patients seek care from healthcare professionals who utilize various manual therapy techniques. Gaining further understanding of the hypoalgesic properties of such techniques can enable practitioners to more skillfully integrate them in managing patients presenting with pain. Previous research has revealed that various manual techniques result in both local and widespread hypoalgesic changes in asymptomatic controls and patients in pain. Much of this previous research has investigated thrust manipulation; however, there is a paucity of similar research investigating these effects in neurodynamic mobilization.
Specific Aims Aim: To assess for immediate local and widespread hypoalgesic effects of neurodynamic mobilization applied to the upper extremity.
Hypotheses:
Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in local and widespread Qualitative Sensory Testing (QST) measures compared to those who receive a sham mobilization.
Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in elbow ROM and reported sensation intensity with upper limb neurodyndamic testing as compared to those who receive a sham mobilization.
Aim: To assess for differences in immediate local and widespread hypoalgesic effects of sliding vs tensioning neurodynamic mobilization techniques applied to the upper extremity
Hypotheses:
Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in local and widespread QST measures compared to those who receive tensioning neurodynamic mobilization
Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in elbow range of motion (ROM) and reported sensation intensity with upper limb neurodynamic testing testing compared to those who receive a tensioning neurodynamic mobilization
Detailed Description
See protocol uploaded in documents section
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Neuropathic
Keywords
neurodynamics, neurodynamic mobilization, quantitative sensory testing, median nerve, pressure pain threshold, thermal pain threshold, thermal pain tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each subject will be randomized to one of three groups:
Neurodynamic Slider Mobilization
Neurodynamic Tensioner Mobilization
Sham Neurodynamic Mobilization
Outcomes will be assessed immediately prior to and immediately following the intervention.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurodynamic Slider Mobilization
Arm Type
Active Comparator
Arm Title
Neurodynamic Tensioner Mobilization
Arm Type
Active Comparator
Arm Title
Sham Neurodynamic Mobilization
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Neurodynamic Slider Mobilization
Other Intervention Name(s)
ULNT2a Slider, MNT2 Slider
Intervention Description
Subjects will be positioned in supine with the examiner supporting his/her arm and facing caudally. The arm will be taken into the ULNT2a position as described in Butler's text - so as to bias the median nerve. Once passive resistance is felt or a feeling of mild tension is reported in the median nerve field, a series of mobilizations will be performed to "slide" the nerve proximally and distally in an alternating manner via providing wrist extension with concurrent shoulder girdle elevation and then providing wrist flexion with concurrent shoulder girdle depression. This will be performed for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position) - not moving further into described tension or passive resistance.
Intervention Type
Other
Intervention Name(s)
Neurodynamic Tensioner Mobilization
Other Intervention Name(s)
ULNT2a Tensioner, MNT2 Tensioner
Intervention Description
Subjects will be positioned in supine with the examiner supporting his/her arm and facing caudally. The arm will be taken into the ULND2a position as described in Butler's text - so as to bias the median nerve. Once passive resistance is felt or a feeling of mild tension is reported in the median nerve field, a series of mobilizations will be performed to "tension" the nerve in an alternating on/off manner via providing wrist extension with concurrent shoulder girdle depression and then providing wrist flexion with concurrent shoulder girdle elevation. This will be performed for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position) - not moving further into described tension or passive resistance.
Intervention Type
Other
Intervention Name(s)
Sham Neurodynamic Mobilization
Intervention Description
Subjects will be positioned in supine with the examiner supporting his/her arm and facing cranially - in a similar position as the UNLD1 test described previously. From here, the therapist will position the patient's arm in 45 deg. of shoulder abduction without scapular depression, 45 deg. of shoulder external rotation, 45 deg. of elbow flexion, and forearm pronation. From this position, a series of sham mobilizations will be performed by passively alternating flexion and extension of the wrist for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position).
Primary Outcome Measure Information:
Title
Pressure Pain Threshold (PPT)
Description
PPT will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior using a pressure algometer with an affixed 1cm2 rubber tip.
Time Frame
change from baseline immediately after intervention
Title
Thermal Pain Threshold (TPT)
Description
TPT will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.
Time Frame
change from baseline immediately after intervention
Title
Thermal Pain Tolerance (TPTol)
Description
TPTol will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.
Time Frame
change from baseline immediately after intervention
Title
Elbow Extension ROM Obtained on Neurodynamic Testing
Description
A neurodynamic test of the median nerve will be performed according to the ULNT1 procedure originally described by David Butler. Degrees of elbow extension will then be recorded using a universal goniometer, and each subject will rate each of the following 5 sensory descriptors on a 10 cm Visual Analog Scale (VAS): "Stinging", "Tingling", "Tightness", "Sharpness", and "Numbness". The average of the 5 sensory descriptor ratings will then be averaged to create a single sensory descriptor VAS score - as outlined in Beneciuk et al 2009.
Time Frame
change from baseline immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18-65
Ability to speak and comprehend English.
Exclusion Criteria:
Current neck or upper extremity symptoms
Disorders that could result in impaired sensation - such as diabetes.
Current use of prescription pain medication or other medications that could result in altered pain perception - such as anti-anxiety medications or anti-depressants.
History of any chronic painful condition
Diagnosis of any major psychiatric disorder
Current pregnancy
Any painful condition within the past 3 months for which care was sought
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Maddox, DPT
Organizational Affiliation
Brenau University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brenau University
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
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