Concurrent Treatment for Patients With Cervical Radiculopathy

NCT03636009 | Unknown

• 1 other identifier: 0924
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Nerve Root Disorder Nos

Keywords

cervical radiculopathy; neck pain; neuromobilizations

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Difference in treatment time between the groups

  4 weeks of intervention

Study Arms (2)

Concurrent traction

EXPERIMENTAL

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; Other: active exercise program; Other: manual therapy to cervical and thoracic spine

Sequential traction

ACTIVE COMPARATOR

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; Other: active exercise program; Other: manual therapy to cervical and thoracic spine

Interventions

concurrent traction and neuromobilization technique 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

Also known as: Concurrent traction, Neurmobilization technique

Concurrent traction

sequential traction and neuromobilization technique OTHER

Participants will receive neuromobilzation techniques followed by supine cervical traction

Also known as: Sequential traction

Sequential traction

active exercise program OTHER

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

Concurrent traction; Sequential traction

manual therapy to cervical and thoracic spine OTHER

Lateral glides to cervical spine and thoracic manipulations

Concurrent traction; Sequential traction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Indianapolis: lead

Study Sites (1)

Michiana Orthopaedics and Sports Physical Therapy

Mishawaka, Indiana, 46544, United States

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Bellew, EdD

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Christianson

CONTACT

574-485-6082; christiansonpj@uindy.edu

James Bellew, EdD

CONTACT

317-788-3522; bellew@uindy.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups receiving interventions

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: October 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)