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Concurrent Treatment for Patients With Cervical Radiculopathy

Primary Purpose

Spinal Nerve Root Disorder Nos

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
concurrent traction and neuromobilization technique
sequential traction and neuromobilization technique
active exercise program
manual therapy to cervical and thoracic spine
Sponsored by
University of Indianapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Nerve Root Disorder Nos focused on measuring cervical radiculopathy, neck pain, neuromobilizations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Michiana Orthopaedics and Sports Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent traction

Sequential traction

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Difference in treatment time between the groups
average minutes in treatment in each group

Full Information

First Posted
August 15, 2018
Last Updated
October 17, 2018
Sponsor
University of Indianapolis
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1. Study Identification

Unique Protocol Identification Number
NCT03636009
Brief Title
Concurrent Treatment for Patients With Cervical Radiculopathy
Official Title
The Concurrent Use of Intermittent Cervical Traction and Neuromobilization Techniques in Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Indianapolis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Nerve Root Disorder Nos
Keywords
cervical radiculopathy, neck pain, neuromobilizations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups receiving interventions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent traction
Arm Type
Experimental
Arm Description
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
Arm Title
Sequential traction
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
concurrent traction and neuromobilization technique
Other Intervention Name(s)
Concurrent traction, Neurmobilization technique
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
sequential traction and neuromobilization technique
Other Intervention Name(s)
Sequential traction
Intervention Description
Participants will receive neuromobilzation techniques followed by supine cervical traction
Intervention Type
Other
Intervention Name(s)
active exercise program
Intervention Description
Participants will have 4-5 exercises to perform at each session
Intervention Type
Other
Intervention Name(s)
manual therapy to cervical and thoracic spine
Intervention Description
Lateral glides to cervical spine and thoracic manipulations
Primary Outcome Measure Information:
Title
changes in pain
Description
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.
Time Frame
after 4 weeks of intervention
Title
changes in function
Description
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.
Time Frame
After 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Difference in treatment time between the groups
Description
average minutes in treatment in each group
Time Frame
4 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Christianson
Phone
574-485-6082
Email
christiansonpj@uindy.edu
First Name & Middle Initial & Last Name or Official Title & Degree
James Bellew, EdD
Phone
317-788-3522
Email
bellew@uindy.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bellew, EdD
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michiana Orthopaedics and Sports Physical Therapy
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
patrick christianson, MHs
Phone
574-807-9995
Email
pchristianson@selectmedical.com
First Name & Middle Initial & Last Name & Degree
James Bellew, EdD
Phone
317-788-3522
Email
bellewj@uindy.ede

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Concurrent Treatment for Patients With Cervical Radiculopathy

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