Concurrent Treatment for Patients With Cervical Radiculopathy

Spinal Nerve Root Disorder Nos Clinical Trial

Official title:

The Concurrent Use of Intermittent Cervical Traction and Neuromobilization Techniques in Patients With Cervical Radiculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03636009
• Other study ID #: 0924
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2018
• Source: University of Indianapolis
• Contact: Patrick Christianson
• Phone: 574-485-6082
• Email: christiansonpj[@]uindy.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of two treatment interventions in patients with cervical radiculopathy. One group will receive a concurrent approach using traction and neuromobilizations. The other group will receive the sequential approach of traction and neuromobilizations

Description:

Physical therapists routinely use cervical traction and manual therapy in patients with cervical radiculopathy. The standard of care is a sequential approach in which the patients receive interventions successively. This study will provide the standard of care approach for one group while the other group receives the concurrent approach in which the patient will have neuromobilizations while they are receiving mechanical traction. Both groups will also receive exercise and manual therapy to the cervical and thoracic spine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Participants that test positive on at least 3 out of 4 special tests.

• Participants will score at least 10 on the Neck Disability Index

• Participants will score at least 2 on the numeric pain rating scale

Exclusion Criteria:

• Do not test positive on at least 3 of 4 special tests.

• Signs of cervical trauma

• Cervical myelopathy

• Active pregnancy

• Medical red flags (fracture, tumor, long term steroid use, rheumatoid arthritis, and osteoporosis)

• Evidence of vascular compromise

• Cervical spine surgery

• Recent injections in the past six weeks

Related Conditions & MeSH terms

• Radiculopathy
• Spinal Nerve Root Disorder Nos

Intervention

Other:
• concurrent traction and neuromobilization technique
participant will be on a mechanical traction machine with an on:off cycle. During the on cycle, the primary researcher will be performing a neuromobilization technique on the symptomatic arm. Patients will also receive exercise and manual therapy
• sequential traction and neuromobilization technique
Participants will receive neuromobilzation techniques followed by supine cervical traction
• active exercise program
Participants will have 4-5 exercises to perform at each session
• manual therapy to cervical and thoracic spine
Lateral glides to cervical spine and thoracic manipulations

Locations

Country	Name	City	State
United States	Michiana Orthopaedics and Sports Physical Therapy	Mishawaka	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in pain	Measured using the Numeric pain rating scale. Minimum score is 0 and maximum score is 10. 0 describes no pain and 10 describes worst pain imaginable.	after 4 weeks of intervention
Primary	changes in function	Measured using the Neck Disability Index. The Neck Disability Index has a minimum score of 0 and maximum score of 50. It is typically expressed as a percentage by multiplying the score by 2. Higher scores represent greater disability.	After 4 weeks of intervention
Secondary	Difference in treatment time between the groups	average minutes in treatment in each group	4 weeks of intervention