Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function

Physical and Rehabilitation Medicine Clinical Trial

Official title:

Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function :Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690959
• Other study ID #: USharjah 2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 22, 2021

Study information

• Verified date: February 2021
• Source: University of Sharjah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A prospective, parallel randomized, controlled study will be conducted at a research laboratory of our University. Participant recruitment will begin following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection.

Per inclusion criteria, subjects will be between 18 and 50 years of age, not currently experiencing any neck or dominant upper extremity symptoms, do not have a history significant for a chronic painful condition, and will not using pain relievers. Prior to participating in any study-related procedures, participants will read and signed an informed consent form approved by the Institutional Review Board.

Participants will be divided into three groups; One group will receive neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve.

. the third group will receive sham neural mobilization intervention . Participants were not given information on which neural mobilization technique they were receiving; they were only told that they could receive one of two different neural mobilization techniques. Six sessions will be given every other day for 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 22, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Physical and Rehabilitation Medicine

Intervention

Other:
• neural mobilization
Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
• Sham intervention
it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.

Locations

Country	Name	City	State
United Arab Emirates	Ibrahim Moustafa	Sharjah	United Arab Emirate
United Arab Emirates	University of Sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Skin Sympathetic response	For measurement of the Skin Sympathetic response, electromyography equipment will be used. The skin temperature will be maintained at 32° )by making the stability of room temperature around 26° C, asking subjects to stay in the room for 20 minutes with that temperature before the examination and prevent local warm-up for extremities) . Active surface electrodes will be attached on the palmar side, and the references will be placed on the dorsum of the hand. The stimulus will be given at the wrist contralateral to the recording side. The latency and peak to peak amplitude will be determined. Sympathetic skin response will be considered absent if there is no response after ten stimuli.	baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week
Secondary	Change in Pressure pain threshold	An algometer will be used to measure Pressure pain threshold at both the thenar eminence and the proximal third of the right ventral forearm. . Before measurements on these points will be taken, Pressure pain threshold measurement will be demonstrated in the opposite upper limb to familiarize the patient with the procedure. Participants will be instructed to say "stop" when the sensation changed from pressure to pain. The Pressure pain threshold will be measured with the patient's hand and forearm in supination and supported on a table. Three measurements will be taken at each point. The mean value was used for between groups comparisons. A 30-second resting period will be allowed between each measurement. The pressure will be applied at a rate of 3 N/s up to a maximum of 60 N, which was not exceeded because of the risk of tissue damage.	baseline (pre-treatment) , 2 weeks of treatment and at 1 week following the end of treatment