Spinal Nerve Root Disorder NosNCT03636009
Concurrent Treatment for Patients With Cervical Radiculopathy
A study testing concurrent traction and neuromobilization technique, sequential traction and neuromobilization technique and active exercise program in people with Spinal Nerve Root Disorder Nos, run by University of Indianapolis at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Nerve Root Disorder Nos
- What is being tested?
- concurrent traction and neuromobilization technique, sequential traction and neuromobilization technique and active exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michiana Orthopaedics and Sports Physical Therapy
Mishawaka, Indiana, 46544
patrick christianson, MHs, 574-807-9995, pchristianson@selectmedical.com
James Bellew, EdD, 317-788-3522, bellewj@uindy.ede
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Nerve Root Disorder Nos
- Being tested
- concurrent traction and neuromobilization technique, sequential traction and neuromobilization technique, active exercise program, manual therapy to cervical and thoracic spine
- Keywords
- cervical radiculopathy, neck pain, neuromobilizations
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent traction and neuromobilization techniqueOther
Also called Concurrent traction, Neurmobilization 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
sequential traction and neuromobilization techniqueOther
Also called Sequential traction
Participants will receive neuromobilzation techniques followed by supine cervical traction
active exercise programOther
Participants will have 4-5 exercises to perform at each session
manual therapy to cervical and thoracic spineOther
Lateral glides to cervical spine and thoracic manipulations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: sequential traction and neuromobilization technique; Other: active exercise program; Other: manual therapy to cervical and thoracic spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 4 weeks of intervention
Secondary outcomes (1)
Difference in treatment time between the groups
average minutes in treatment in each group
Measured: 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Nerve Root Disorder NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups receiving interventions
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Bellew, University of Indianapolis
- Investigators
- James Bellew, EdD, Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636009
- Sponsor's protocol ID
- 0924
- Status last verified
- Oct 2018
- First submitted
- 15 Aug 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Concurrent Use of Intermittent Cervical Traction and Neuromobilization Techniques in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT03636009
- Acronym / sponsor ID
- 0924
- Conditions
- Spinal Nerve Root Disorder Nos
- Keywords
- cervical radiculopathy, neck pain, neuromobilizations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups receiving interventions
| Arm | Type | Receives |
|---|---|---|
| Concurrent traction | Experimental | Other: concurrent traction and neuromobilization technique, Other: active exercise program, Other: manual therapy to cervical and thoracic spineConcurrent 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 | Active comparator | Other: sequential traction and neuromobilization technique, Other: active exercise program, Other: manual therapy to cervical and thoracic spineSequential 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concurrent traction and neuromobilization techniqueAlso: Concurrent traction, Neurmobilization techniqueparticipant 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 | Concurrent traction |
| sequential traction and neuromobilization techniqueAlso: Sequential tractionParticipants will receive neuromobilzation techniques followed by supine cervical traction | Other | Sequential traction |
| active exercise programParticipants will have 4-5 exercises to perform at each session | Other | Concurrent traction, Sequential traction |
| manual therapy to cervical and thoracic spineLateral glides to cervical spine and thoracic manipulations | Other | Concurrent traction, Sequential traction |
Primary outcome
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.
1 secondary outcome
Difference in treatment time between the groups
Time frame: 4 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Bellew, EdD principal investigator
University of Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concurrent traction and neuromobilization technique, sequential traction and neuromobilization technique and active exercise program in people with Spinal Nerve Root Disorder Nos, run by University of Indianapolis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Christianson (574-485-6082, christiansonpj@uindy.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in pain (time frame: after 4 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.