What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?

Cervical Radiculopathy Clinical Trial

Official title:

What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03898739
• Other study ID #: Traction decompression angle
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: Abeer F Hanafy, PhD
• Phone: 01063044443
• Email: abeerfarag22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effect of different angles of decompression on the Flexor Carpi Radialis (FCR) H-Reflex in patients with cervical radiculopathy

Description:

Cervical traction has long been defined as a distracting force that separate the cervical segments and relieve nerve roots compression. Yet, there is lack of knowledge that reports the effects of different traction decompression angles and determines the proper angle of pull among different angles of decompression system

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients will be included in the study if they have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities, second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI, and diagnosed as cervical disc protrusion (C5- C7) for at least three months.

Exclusion Criteria:

• Patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck, short neck (churchill neck), marked facet joint, neuro-central joint arthropathic pathology, osteoporotic patients.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Other:
• Cervical Traction from different angles
Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Khan RR, Awan WA, Rashid S, Masood T. A randomized controlled trial of intermittent Cervical Traction in sitting Vs. Supine position for the management of Cervical Radiculopathy. Pak J Med Sci. 2017 Nov-Dec;33(6):1333-1338. doi: 10.12669/pjms.336.13851. — View Citation

Liu J, Ebraheim NA, Sanford CG Jr, Patil V, Elsamaloty H, Treuhaft K, Farrell S. Quantitative changes in the cervical neural foramen resulting from axial traction: in vivo imaging study. Spine J. 2008 Jul-Aug;8(4):619-23. Epub 2007 Jun 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Flexor Carpi radialis H-reflex	The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient	Changes from Baseline to 6-weeks after treatment