NCT05813002

Brief Summary

the main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

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

April 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 1, 2023

Last Update Submit

April 1, 2023

Conditions

Keywords

Randomized controlled trialNeurodynamicsEvoked potentialSomatosensory

Outcome Measures

Primary Outcomes (1)

  • Change in dermatomal somatosensory evoked potentials.

    In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at \< 5 k Cutaneous areas of C5,C6,C7 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.

    baseline (pre-treatment) and immediately after the treatment

Study Arms (3)

standard neurodynamic sequence

ACTIVE COMPARATOR

Participants in the first group will receive the standard neurodynamic sequence. The starting position for this sequence will be shoulder in extension with lateral rotation, elbow in full flexion and wrist in neutral position. Passively the shoulder is abducted till 90 degrees followed by wrist extension then ended by elbow extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions

Other: standard neural mobilization

Distal to proximal neurodynamic sequence

ACTIVE COMPARATOR

The second group participants will receive the distal to proximal neurodynamic sequence. For this sequence the starting position will be shoulder in full extension with lateral rotation, elbow fully extended and wrist in neutral position. the sequence will start with wrist extension, going to elbow extension, and ending with shoulder abduction. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions

Other: Distal to proximal neural mobilization

proximal to distal neurodynamic sequence

ACTIVE COMPARATOR

The participants in the third experimental group will receive the proximal to distal sequence which will start with shoulder abduction, elbow extension and then wrist extension. The starting position is shoulder in extension and laterally rotated, elbow in full flexion, and wrist in neutral position. The shoulder will be passively mobilized to 90 degrees of abduction, elbow into full extension and wrist in full extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions

Other: proximal to distal neural mobilization

Interventions

is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.

standard neurodynamic sequence

is a distal to proximal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.

Distal to proximal neurodynamic sequence

is a proximal to distal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.

proximal to distal neurodynamic sequence

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • not currently experiencing any neck or dominant upper extremity symptoms.
  • do not have a history significant for a chronic painful condition.
  • do not using pain relievers.

You may not qualify if:

  • inflammatory joint disease or other systemic pathologies.
  • prior history of overt injury and surgery relating to the musculoskeletal system.
  • disorder related to the spine and extremities.
  • musculoskeletal pain in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ibrahim M moustafa, Professor

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim M [imoustafa], Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor, who took the measurements for all groups will be blinded to the subject's group.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to one of three different groups. One group will receive the standard neural mobilization, the second group will receive Distal-Proximal neural mobilization, and the third group will receive Proximal-Distal neural mobilization, all targeting the median nerve.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-chair of Physiotherapy Department

Study Record Dates

First Submitted

April 1, 2023

First Posted

April 14, 2023

Study Start

April 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

no plan to make individual participant data (IPD) available to other researchers.