NCT04690959

Brief Summary

the current study will try to answer the question: Is it theoretically possible, that increased longitudinal stress on nerve root from sliding or tensioning intervention may subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently affect the neural function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

13 days

First QC Date

December 26, 2020

Last Update Submit

February 27, 2021

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 L3,L4,L5, S1 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) , 2 weeks ,through study completion, an average of 1 week

Secondary Outcomes (2)

  • Change in Skin Sympathetic response

    baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week

  • Change in Pressure pain threshold

    baseline (pre-treatment) , 2 weeks of treatment and at 1 week following the end of treatment

Study Arms (3)

Neural gliding mobilization

EXPERIMENTAL

Initial participant positioning for gliding will be : lying in supine, shoulder at approximately 90 of abduction, wrist in neutral, elbow at 90 flexion and head/neck neutral. From this starting position, participants actively and simultaneously will perform extension of the elbow (to 45) and ipsilateral neck flexion (to approximately 45) and then returned to 90 of elbow flexion and 45 of contralateral neck flexion while maintaining the shoulder at 90 abduction. According to Silva et al., (2014) this combination of movements was the one that promoted the greatest excursion of the median nerve (10.2 mm) . For gliding, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series was performed.

Other: neural mobilization

Neural tensioning mobilization

EXPERIMENTAL

Tensioning will be performed with the subject lying supine. The investigator will perform the upper limb neurodynamic test as reported by Butler (2000): shoulder depression; 110 of shoulder abduction; external shoulder rotation; wrist and fingers extension; forearm supination and then elbow extension. The final test position will be defined as either i) end of joint amplitude or ii) the joint amplitude that provokes pain, paresthesia or numbness. In this case, a decrease of 5 to 10 of range of motion (elbow extension) will be allowed for symptoms to disappear and from this end position the investigator will perform repetitive movements of approximately 10 of elbow flexion/extension while maintaining the test end position for all the other joints. For tensioning, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series will be performed. After each cycle of 10 repetitions, the position will be held for 10 seconds.

Other: neural mobilization

Control

SHAM COMPARATOR

Participants in the sham group will receive a treatment consisting of maneuvers that mimic the neural mobilization treatment but not to stress the neural tissues in the upper extremity. The sham mobilization consists of passively positioning the participants in the following consecutive positions: (1) a neutral cervical spine (0° of lateral flexion), (2) 45°of shoulder abduction without scapula depression, and (3) 45° of shoulder external rotation combined with 45° of elbow flexion with forearm pronation. This will be immediately followed by 10 cycles of passive wrist flexion/extension at a rate of approximately 6 seconds per cycle (3 seconds into extension and 3 seconds into flexion) . Upon moving from wrist flexion to extension, an initial sense of resistance will be used as a sign to alternate directions. Following the 10th cycle, a static hold will be maintained while in wrist flexion for 10 seconds.

Other: Sham intervention

Interventions

Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.

Also known as: neurodynamics
Neural gliding mobilizationNeural tensioning mobilization

it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.

Control

Eligibility Criteria

Age18 Years - 30 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 Sites (2)

Ibrahim Moustafa

Sharjah city, United Arab Emirate, 27272, United Arab Emirates

Location

University of Sharjah

Sharjah city, 27272, United Arab Emirates

Location

Study Officials

  • Ibrahim Moustafa, associate professor

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participants as well as The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor-chair of Physiotherapy Department Affiliation: University of Sharjah

Study Record Dates

First Submitted

December 26, 2020

First Posted

December 31, 2020

Study Start

January 1, 2021

Primary Completion

January 14, 2021

Study Completion

January 22, 2021

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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

Locations