- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674489
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Gainesville, Georgia, United States, 30501
- Brenau University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 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:
|
|
ACTIVE_COMPARATOR: 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:
|
|
SHAM_COMPARATOR: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change from baseline immediately after intervention
|
|
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.
|
change from baseline immediately after intervention
|
|
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.
|
change from baseline immediately after intervention
|
|
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.
|
change from baseline immediately after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Maddox, DPT, Brenau University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1208684-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
Clinical Trials on Neurodynamic Slider Mobilization
-
Riphah International UniversityCompleted
-
Cairo UniversityKafrelsheikh UniversityCompleted
-
Uğur SözlüGazi UniversityCompleted
-
Deraya UniversityCompletedLow Back Pain | Lumbar RadiculopathyEgypt
-
Dow University of Health SciencesRecruitingCarpal Tunnel SyndromePakistan
-
Cairo UniversityNot yet recruitingCarpal Tunnel Syndrome | Median Nerve EntrapmentEgypt
-
Aydin Adnan Menderes UniversityCompletedLow Back Pain | Lumbar Disc HerniationTurkey (Türkiye)
-
Cairo UniversityCompletedCervical Radiculopathy | Electromyography | Neuromobılızatıon | Nerve Conduction | Median NerveEgypt
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
The Hong Kong Polytechnic UniversityUnknownRheumatoid ArthritisHong Kong