Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedDecember 9, 2019
December 1, 2019
10 months
September 13, 2018
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
change from baseline immediately after intervention
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.
change from baseline immediately after intervention
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.
change from baseline immediately after intervention
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.
change from baseline immediately after intervention
Study Arms (3)
Neurodynamic Slider Mobilization
ACTIVE COMPARATORNeurodynamic Tensioner Mobilization
ACTIVE COMPARATORSham Neurodynamic Mobilization
SHAM COMPARATORInterventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- Age: 18-65
- Ability to speak and comprehend English.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brenau University
Gainesville, Georgia, 30501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Maddox, DPT
Brenau University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 17, 2018
Study Start
October 1, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
December 9, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share