Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls

• ClinicalTrials.gov Identifier: NCT03674489
• Recruitment Status: Completed
• First Posted: September 17, 2018
• Last Update Posted: December 9, 2019
• Sponsor: Brenau University
• Information provided by (Responsible Party): Daniel Maddox, PT, DPT, Brenau University

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
Pain; Pain, Neuropathic	Other: Neurodynamic Slider Mobilization; Other: Neurodynamic Tensioner Mobilization; Other: Sham Neurodynamic Mobilization	Not Applicable

Detailed Description:

See protocol uploaded in documents section

Study Design

• Study Type: Interventional (Clinical Trial)
• 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.

• 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: October 1, 2018
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: August 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Georgia

Brenau University

Gainesville, Georgia, United States, 30501

Sponsors and Collaborators

Brenau University

Investigators

• Principal Investigator: Daniel Maddox, DPT; Brenau University

More Information

• Responsible Party: Daniel Maddox, PT, DPT, Assistant Professor, Brenau University
• ClinicalTrials.gov Identifier: NCT03674489
• Other Study ID Numbers: 1208684-5
• First Posted: September 17, 2018
• Last Update Posted: December 9, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• 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, Brenau University:

neurodynamics; neurodynamic mobilization; quantitative sensory testing; median nerve; pressure pain threshold; thermal pain threshold; thermal pain tolerance

Additional relevant MeSH terms:

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations