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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04484324
Other study ID # USharjah2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2020
Est. completion date July 20, 2020

Study information

Verified date December 2020
Source University of Sharjah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. One of these parameters, that might be affecting the treatment outcome the most, is the stretching duration, thus far there is a little agreement on the optimal stretching duration. This non agreement in exact stretching parameters is obvious between authors and researchers in the field of muscle energy techniques (MET) as well as those who have used and advocate various durations for the passive stretch that follows the contraction phase in MET.


Description:

comparison and subsequent conclusions about appropriate stretching times are mainly based on mechanical factors such as range of motion and flexibility, while ignoring the neural adversative mechanical tension that may be created during stretching exercises. According to the literature , stretching induced neural tension may adversely affect the central nervous system and nerve root function due to the absence of the perineurium, which is the primary load carrying structure. Thus, safe or unsafe limits of nerve elongation are not well established, despite several basic scientific and clinical studies.. Consequently, in the present study, the current study aimed to answer the question: Is it theoretically possible, that increased longitudinal strain and stress on the spinal cord and nerve root from continuous stretching exercises may subtly impair the neural function? Our hypothesis is that a duration threshold exists where, once reached, adverse neural function will be apparent resulting in a reduction of either or both latency and amplitudes of evoked potentials.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 20, 2020
Est. primary completion date July 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Eligible patients had to be between 18 and 40 years of age - have generalized neck pain for more than 3 months. - with symptoms provoked by neck postures, movements, or palpation Exclusion Criteria: - Subjects' exclusion criteria included specific neck pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory or rheumatic disease. Furthermore, subjects were excluded if they had a history of spine surgery and any objective findings consistent with neurological conditions and vascular disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stretching exercises
Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.

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, 

References & Publications (1)

Allison, T, G McCarthy, C C Wood, and S J Jones. 1991. "Potentials Evoked in Human and Monkey Cerebral Cortex by Stimulation of the Median Nerve. A Review of Scalp and Intracranial Recordings." Brain : A Journal of Neurology, December, 2465-2503. Baker, P

Outcome

Type Measure Description Time frame Safety issue
Primary The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials Dermatomal Somatosensory Evoked Potentials will be elicited by repetitive, square wave (0.5 ms) electrical pulses (at 3 Hz) from standard clinical surface gel electrodes (20 mm) overlying cervical sensory dermatomes. Dermatomal somatosensory evoked potential will be collected at a stimulus intensity well above perception threshold.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 C4 to C8 dermatomes being stimulated will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Secondary The change in Neck Disability Index The Neck Disability Index , consisting of 10 items related to daily living activities, will be our primary patient-reported outcome measure. Each item is scored out of five (with the no disability response given a score of 0) giving a total score for the questionnaire out of 50. Higher scores represent greater disability. will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Secondary The change in Cervical range of motion Cervical spine global range-of-motion will be measured using the valid and reliable cervical range-of-motion (CROM) device. The participant will perform flexion, extension, right/left lateral flexion, right/left rotation in upright sitting. The patient was instructed to perform each movement when he/she attained the maximum active range of motion. Three trials were conducted for each direction of movement, and the average of the three measurements will be recorded for analysis. will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Secondary The change in Neck pain intensity Neck pain intensity will be measured using the numerical pain rating scale . The patients will be asked to place a mark along the line indicating their current pain intensity; 0 reflecting ''no pain'' and 10 reflecting the ''worst pain''. will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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