Concurrent Treatment for Patients With Cervical Radiculopathy

Sponsor

University of Indianapolis (Other)

Overall Status

Unknown status

CT.gov ID

NCT03636009

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Nerve Root Disorder Nos	Other: concurrent traction and neuromobilization technique Other: sequential traction and neuromobilization technique Other: active exercise program Other: manual therapy to cervical and thoracic spine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups receiving interventionsTwo groups receiving interventions

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concurrent traction 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	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 Other Names: Concurrent traction Neurmobilization technique Other: active exercise program Participants will have 4-5 exercises to perform at each session Other: manual therapy to cervical and thoracic spine Lateral glides to cervical spine and thoracic manipulations
Active Comparator: Sequential traction 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	Other: sequential traction and neuromobilization technique Participants will receive neuromobilzation techniques followed by supine cervical traction Other Names: Sequential traction Other: active exercise program Participants will have 4-5 exercises to perform at each session Other: manual therapy to cervical and thoracic spine Lateral glides to cervical spine and thoracic manipulations

Arm

Intervention/Treatment

Experimental: Concurrent traction

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

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

Other Names:

Concurrent traction

Neurmobilization technique

Other: active exercise program

Participants will have 4-5 exercises to perform at each session

Other: manual therapy to cervical and thoracic spine

Lateral glides to cervical spine and thoracic manipulations

Active Comparator: Sequential traction

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

Other: sequential traction and neuromobilization technique

Participants will receive neuromobilzation techniques followed by supine cervical traction

Other Names:

Sequential traction

Other: active exercise program

Participants will have 4-5 exercises to perform at each session

Other: manual therapy to cervical and thoracic spine

Lateral glides to cervical spine and thoracic manipulations

Outcome Measures

Primary Outcome Measures

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

Difference in treatment time between the groups [4 weeks of intervention]
average minutes in treatment in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michiana Orthopaedics and Sports Physical Therapy	Mishawaka	Indiana	United States	46544

Sponsors and Collaborators

University of Indianapolis

Investigators

Principal Investigator: James Bellew, EdD, University of Indianapolis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James W. Bellew, Professor, University of Indianapolis

ClinicalTrials.gov Identifier:

NCT03636009

Other Study ID Numbers:

0924

First Posted:

Aug 17, 2018

Last Update Posted:

Oct 19, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by James W. Bellew, Professor, University of Indianapolis

cervical radiculopathy

neck pain

neuromobilizations

Additional relevant MeSH terms:

Radiculopathy

Study Results

No Results Posted as of Oct 19, 2018