Concurrent Treatment for Patients With Cervical Radiculopathy
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| ClinicalTrials.gov Identifier: NCT03636009 |
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Recruitment Status : Unknown
Verified October 2018 by James W. Bellew, University of Indianapolis.
Recruitment status was: Recruiting
First Posted : August 17, 2018
Last Update Posted : October 19, 2018
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Sponsor:
University of Indianapolis
Information provided by (Responsible Party):
James W. Bellew, University of Indianapolis
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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 | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Two 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 : | October 1, 2018 |
| Estimated Primary Completion Date : | July 31, 2019 |
| Estimated Study Completion Date : | September 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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
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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:
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 |
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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
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Other: sequential traction and neuromobilization technique
Participants will receive neuromobilzation techniques followed by supine cervical traction
Other Name: 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 |
Primary Outcome Measures :
- changes in pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 weeks of intervention ]average minutes in treatment in each group
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636009
Contacts
| Contact: Patrick Christianson | 574-485-6082 | christiansonpj@uindy.edu | |
| Contact: James Bellew, EdD | 317-788-3522 | bellew@uindy.edu |
Locations
| United States, Indiana | |
| Michiana Orthopaedics and Sports Physical Therapy | Recruiting |
| Mishawaka, Indiana, United States, 46544 | |
| Contact: patrick christianson, MHs 574-807-9995 pchristianson@selectmedical.com | |
| Contact: James Bellew, EdD 317-788-3522 bellewj@uindy.ede | |
Sponsors and Collaborators
University of Indianapolis
Investigators
| Principal Investigator: | James Bellew, EdD | University of Indianapolis |
| Responsible Party: | James W. Bellew, Professor, University of Indianapolis |
| ClinicalTrials.gov Identifier: | NCT03636009 |
| Other Study ID Numbers: |
0924 |
| First Posted: | August 17, 2018 Key Record Dates |
| Last Update Posted: | October 19, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by James W. Bellew, University of Indianapolis:
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cervical radiculopathy neck pain neuromobilizations |
Additional relevant MeSH terms:
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Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |