Concurrent Treatment for Patients With Cervical Radiculopathy

NCT ID: NCT03636009

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Nerve Root Disorder Nos

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups receiving interventions
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

concurrent traction and neuromobilization technique

Intervention Type OTHER

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

active exercise program

Intervention Type OTHER

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

manual therapy to cervical and thoracic spine

Intervention Type OTHER

Lateral glides to cervical spine and thoracic manipulations

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

Group Type ACTIVE_COMPARATOR

sequential traction and neuromobilization technique

Intervention Type OTHER

Participants will receive neuromobilzation techniques followed by supine cervical traction

active exercise program

Intervention Type OTHER

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

manual therapy to cervical and thoracic spine

Intervention Type OTHER

Lateral glides to cervical spine and thoracic manipulations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

sequential traction and neuromobilization technique

Participants will receive neuromobilzation techniques followed by supine cervical traction

Intervention Type OTHER

active exercise program

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

Intervention Type OTHER

manual therapy to cervical and thoracic spine

Lateral glides to cervical spine and thoracic manipulations

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Concurrent traction Neurmobilization technique Sequential traction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Indianapolis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James W. Bellew

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Bellew, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Indianapolis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michiana Orthopaedics and Sports Physical Therapy

Mishawaka, Indiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick Christianson

Role: CONTACT

574-485-6082

James Bellew, EdD

Role: CONTACT

317-788-3522

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

patrick christianson, MHs

Role: primary

574-807-9995

James Bellew, EdD

Role: backup

317-788-3522

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0924

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.