Mechanical Neck Pain Clinical Trial
Official title:
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain: A Randomized Controlled Trial
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 |
Verified date | December 2020 |
Source | University of Sharjah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Ibrahim Moustafa | Sharjah | United Arab Emirate |
United Arab Emirates | University of Sharjah | Sharjah |
Lead Sponsor | Collaborator |
---|---|
University of Sharjah |
United Arab Emirates,
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
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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