An interventional study of Stretching exercises and Two way traction in Cervical Lordosis Rehabilitation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL \< 25° will be included. Patients will be assigned randomly into two equal groups, study and control . Both groups will receive neck stretching and exercises and infrared; additionally the study group will receive cervical extension traction. Treatments will be applied 3 time per week for 10 weeks after which groups will be followed for 3-months and 2-years. Amplitude of dermatomal somatosensory evoked potentials (DSSEPS), Cervical lordosis, and pain scales (NRS) will be measured.
Previous studies testing the effects of 3-point bending types of cervical traction, have not clarified exactly what impact the sagittal cervical curve correction has on nerve root function and pain responses associated with improving an abnormal cervical lordosis in cervical spondylotic patients. The present randomized controlled trial will be undertaken to investigate the neurophysiological and pain response outcomes of 3-point bending (2-way) traction compared to standard care in patient cases with lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study will be that cervical lordosis restoration will have short- and long-term effects on DSSEPs and pain outcomes in CSR patients.
30 studies on the registry are indexed under Lordosis; 5 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 15 interventional studies indexed under Lordosis.
Browse Lordosis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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The study group will receive 3-point bending cervical extension traction following the protocol of Harrison et al. The duration of each session will starte at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session
Other: Stretching exercises · Other: Two way traction
Stretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform.
Other: Stretching exercises
Exercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times
During the traction, the head halter will be fixed posteriorly to cause slight distraction, retraction, and slight extension and at the same time a front anterior strap had weight will be applied over a pulley that allows transverse traction load to be applied to the apex of the participants cervical curve alteration. Weights will start at 15 lbs. (6.8 Kg) on the anterior strap and will increase over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 Kg).
The Change in amplitude of dermatomal somatosensory evoked potentials
In all dermatomes, two complete recording runs will be undertaken during each session, with averages of 250-1,200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C6, C7, and C8 dermatomes being stimulated
Time frame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
The change in pain intensity
Measurement of pain will be performed by using a visual analogue scale (VAS). The subjects will be asked about the perception of pain using a 10-cm line with 0 (no pain) on one end and 10 (worst pain) on the other. subjects will be asked to place a mark along the line to denote their level of pain
Time frame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jan 2022, 24 months.
Of 11 interventional studies with no phase under Lordosis, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 24 months is above that.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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