Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls

Sponsor
Brenau University (Other)
Overall Status
Completed
CT.gov ID
NCT03674489
Collaborator
(none)
60
1
3
10
6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Neurodynamic Slider Mobilization
  • Other: Neurodynamic Tensioner Mobilization
  • Other: Sham Neurodynamic Mobilization
N/A

Detailed Description

See protocol uploaded in documents section

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Neurodynamic Slider Mobilization

Other: Neurodynamic Slider Mobilization
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.
Other Names:
  • ULNT2a Slider
  • MNT2 Slider
  • Active Comparator: Neurodynamic Tensioner Mobilization

    Other: Neurodynamic Tensioner Mobilization
    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.
    Other Names:
  • ULNT2a Tensioner
  • MNT2 Tensioner
  • Sham Comparator: Sham Neurodynamic Mobilization

    Other: Sham Neurodynamic Mobilization
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Pressure Pain Threshold (PPT) [change from baseline immediately after intervention]

      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.

    2. Thermal Pain Threshold (TPT) [change from baseline immediately after intervention]

      TPT will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.

    3. Thermal Pain Tolerance (TPTol) [change from baseline immediately after intervention]

      TPTol will be assessed bilaterally over the thenar eminences, over the dorsal aspect of the 1st carpometacarpal (CMC) joint, and over the tibialis anterior.

    4. Elbow Extension ROM Obtained on Neurodynamic Testing [change from baseline immediately after intervention]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brenau University Gainesville Georgia United States 30501

    Sponsors and Collaborators

    • Brenau University

    Investigators

    • Principal Investigator: Daniel Maddox, DPT, Brenau University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Maddox, PT, DPT, Assistant Professor, Brenau University
    ClinicalTrials.gov Identifier:
    NCT03674489
    Other Study ID Numbers:
    • 1208684-5
    First Posted:
    Sep 17, 2018
    Last Update Posted:
    Dec 9, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Maddox, PT, DPT, Assistant Professor, Brenau University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 9, 2019