NCT03674489

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

September 13, 2018

Last Update Submit

December 5, 2019

Conditions

Keywords

neurodynamicsneurodynamic mobilizationquantitative sensory testingmedian nervepressure pain thresholdthermal pain thresholdthermal pain tolerance

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 COMPARATOR
Other: Neurodynamic Slider Mobilization

Neurodynamic Tensioner Mobilization

ACTIVE COMPARATOR
Other: Neurodynamic Tensioner Mobilization

Sham Neurodynamic Mobilization

SHAM COMPARATOR
Other: Sham Neurodynamic Mobilization

Interventions

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.

Also known as: ULNT2a Slider, MNT2 Slider
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 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.

Also known as: ULNT2a Tensioner, MNT2 Tensioner
Neurodynamic Tensioner 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).

Sham Neurodynamic Mobilization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

PainNeuralgia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Daniel Maddox, DPT

    Brenau University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
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

Locations