Concurrent Treatment for Patients With Cervical Radiculopathy

Not Applicable

• Conditions: Spinal Nerve Root Disorder Nos
• Interventions: Other: concurrent traction and neuromobilization technique; Other: sequential traction and neuromobilization technique; Other: active exercise program; Other: manual therapy to cervical and thoracic spine

• Registration Number: NCT03636009
• Lead Sponsor: University of Indianapolis

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2018-10
• Study Start: 2018-10-01
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19
• Primary Completion: 2019-07-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent traction	concurrent traction and neuromobilization technique	Concurrent traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session
Concurrent traction	active exercise program	Concurrent traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session
Concurrent traction	manual therapy to cervical and thoracic spine	Concurrent traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session
Sequential traction	manual therapy to cervical and thoracic spine	Sequential traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session
Sequential traction	sequential traction and neuromobilization technique	Sequential traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session
Sequential traction	active exercise program	Sequential traction and neuromobilization technique at each scheduled session Active exercise program (4-5 exercises) at each session Manual therapy to cervical and thoracic spine at each session

Primary Outcome Measures

Name	Time	Method
changes in pain	after 4 weeks of intervention	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.
changes in function	After 4 weeks of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Difference in treatment time between the groups	4 weeks of intervention	average minutes in treatment in each group

Trial Locations

Locations (1)

Michiana Orthopaedics and Sports Physical Therapy; 🇺🇸 Mishawaka, Indiana, United States