PainNCT03674489
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
A study testing Neurodynamic Slider Mobilization and Neurodynamic Tensioner Mobilization in people with Pain and Pain, Neuropathic, run by Brenau University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain, Neuropathic
- What is being tested?
- Neurodynamic Slider Mobilization and Neurodynamic Tensioner Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65
- Ability to speak and comprehend English.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the detailed description
See protocol uploaded in documents section
- Conditions
- Pain, Pain, Neuropathic
- Being tested
- Neurodynamic Slider Mobilization, Neurodynamic Tensioner Mobilization, Sham Neurodynamic Mobilization
- Keywords
- neurodynamics, neurodynamic mobilization, quantitative sensory testing, median nerve, pressure pain threshold, thermal pain threshold, thermal pain tolerance
- Medical subject headings
- Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic Slider MobilizationOther
Also called ULNT2a Slider, MNT2 Slider
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.
Neurodynamic Tensioner MobilizationOther
Also called ULNT2a Tensioner, MNT2 Tensioner
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.
Sham Neurodynamic MobilizationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Neurodynamic Slider Mobilization | Active comparator | Not described Receives: Other: Neurodynamic Slider Mobilization |
| Neurodynamic Tensioner Mobilization | Active comparator | Not described Receives: Other: Neurodynamic Tensioner Mobilization |
| Sham Neurodynamic Mobilization | Sham comparator | Not described Receives: Other: Sham Neurodynamic Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brenau University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Maddox, PT, DPT, Brenau University
- Investigators
- Daniel Maddox, DPT, Principal investigator, Brenau University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674489
- Sponsor's protocol ID
- 1208684-5
- Status last verified
- Dec 2019
- First submitted
- 13 Sep 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls
- ClinicalTrials.gov ID
- NCT03674489
- Acronym / sponsor ID
- 1208684-5
- Conditions
- Pain, Pain, Neuropathic
- Keywords
- neurodynamics, neurodynamic mobilization, quantitative sensory testing, median nerve, pressure pain threshold, thermal pain threshold, thermal pain tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brenau UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
See protocol uploaded in documents section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-65
- Ability to speak and comprehend English.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodynamic Slider MobilizationAlso: ULNT2a Slider, MNT2 SliderSubjects 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 | Neurodynamic Slider Mobilization |
| Neurodynamic Tensioner MobilizationAlso: ULNT2a Tensioner, MNT2 TensionerSubjects 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 | Neurodynamic Tensioner Mobilization |
| Sham Neurodynamic MobilizationSubjects 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). | Other | Sham Neurodynamic Mobilization |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Maddox, DPT principal investigator
Brenau University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic Slider Mobilization and Neurodynamic Tensioner Mobilization in people with Pain and Pain, Neuropathic, run by Brenau University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: change from baseline immediately after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.