Concurrent Treatment for Patients With Cervical Radiculopathy

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Christianson; Phone Number: 574-485-6082; Email: christiansonpj@uindy.edu
• Study Contact Backup: Name: James Bellew, EdD; Phone Number: 317-788-3522; Email: bellew@uindy.edu

Study Locations

• United States
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • Recruiting
      • Michiana Orthopaedics and Sports Physical Therapy
      • Contact: patrick christianson, MHs; Phone Number: 574-807-9995; Email: pchristianson@selectmedical.com
      • Contact: James Bellew, EdD; Phone Number: 317-788-3522; Email: bellewj@uindy.ede

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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; Other: sequential traction and neuromobilization technique; Participants will receive neuromobilzation techniques followed by supine cervical traction; Other Names: Sequential traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in treatment time between the groups	average minutes in treatment in each group	4 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Indianapolis
• Investigators: Principal Investigator: James Bellew, EdD, University of Indianapolis

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: neck pain; cervical radiculopathy; neuromobilizations
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 0924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No