Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function
1 other identifier
interventional
90
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
2 active sites
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
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2021
CompletedMarch 2, 2021
February 1, 2021
13 days
December 26, 2020
February 27, 2021
Conditions
Keywords
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
EXPERIMENTALInitial 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.
Neural tensioning mobilization
EXPERIMENTALTensioning 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.
Control
SHAM COMPARATORParticipants 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.
Interventions
Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.
Eligibility Criteria
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
University of Sharjah
Sharjah city, 27272, United Arab Emirates
Study Officials
- PRINCIPAL INVESTIGATOR
Ibrahim Moustafa, associate professor
University of Sharjah
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
- 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