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临床试验/NCT04690959
NCT04690959已完成不适用

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

University of Sharjah2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in dermatomal somatosensory evoked potentials

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: neural mobilization (Other)

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.

干预措施: neural mobilization (Other)

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.

干预措施: Sham intervention (Other)

结局指标

主要结局

Change in dermatomal somatosensory evoked potentials

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

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Moustafa

Associate professor-chair of Physiotherapy Department Affiliation: University of Sharjah

University of Sharjah

研究点 (2)

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