Cervical RadiculopathyNCT00695006
Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
A study testing Traction in people with Cervical Radiculopathy, run by Rocky Mountain University of Health Professions at 1 site in United States.
Trial summary
To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Traction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2008
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 of 4 positive on CPR, 18-70yrs
Who cannot join
- history of previous cervical or thoracic spine surgery
- bilateral upper extremity symptoms
- signs or symptoms of UMN disease
- medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
- cervical spine injections (steroidal) in the past two weeks
- current use of steroidal medication prescribed for their radiculopathy symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Advance Rehab at Fredericksburg Orthopaedics
Fredericksburg, Virginia, 22401
About this study
To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.
- Conditions
- Cervical Radiculopathy
- Being tested
- Sham Traction, Traction
- Keywords
- manual therapy, cervical traction, cervical radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TractionOther
Traction <5lbs
TractionOther
Standard supine intermittent traction
| Study group | Role | What they receive |
|---|---|---|
| II | Sham comparator | Sham Traction Receives: Other: Sham Traction |
| I | Active comparator | Traction Receives: Other: Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: 2wk, 4wk, 3mo, 6mo
Patient Specific Functional Scale
Measured: 2wk, 4wk, 3mo, 6mo
Numeric Pain Rating Scale
Measured: 2wk, 4wk, 3mo, 6mo
Secondary outcomes (5)
Global Rating Of Change
Measured: 2wk, 4wk, 3mo, 6mo
Body Diagram
Measured: 2wk, 4wk, 3mo, 6mo
Fear Avoidance Belief Questionnaire
Measured: 2wk, 4wk, 3mo, 6mo
Satisfaction
Measured: 2wk, 4wk, 3mo, 6mo
Grip Strength
Measured: 2wk, 4wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain University of Health Professions
- Sponsor type
- University, hospital or other
- Investigators
- Ian A Young, PT, Principal investigator, Advance Rehab at Fredericksburg Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695006
- Sponsor's protocol ID
- 5388642
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 25 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
- ClinicalTrials.gov ID
- NCT00695006
- Acronym / sponsor ID
- 5388642
- Conditions
- Cervical Radiculopathy
- Keywords
- manual therapy, cervical traction, cervical radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Rocky Mountain University of Health ProfessionsUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (estimated)
- First posted
- 11 Jun 2008 (estimated)
- 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.
To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| II | Sham comparator | Other: Sham TractionSham Traction |
| I | Active comparator | Other: TractionTraction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 3 of 4 positive on CPR, 18-70yrs
Key exclusion criteria (6 listed)
- history of previous cervical or thoracic spine surgery
- bilateral upper extremity symptoms
- signs or symptoms of UMN disease
- medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
- cervical spine injections (steroidal) in the past two weeks
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 |
|---|---|---|
| Sham TractionTraction <5lbs | Other | II |
| TractionStandard supine intermittent traction | Other | I |
Primary outcome
Neck Disability Index
Time frame: 2wk, 4wk, 3mo, 6mo
Patient Specific Functional Scale
Time frame: 2wk, 4wk, 3mo, 6mo
Numeric Pain Rating Scale
Time frame: 2wk, 4wk, 3mo, 6mo
5 secondary outcomes
Global Rating Of Change
Time frame: 2wk, 4wk, 3mo, 6mo
Body Diagram
Time frame: 2wk, 4wk, 3mo, 6mo
Fear Avoidance Belief Questionnaire
Time frame: 2wk, 4wk, 3mo, 6mo
Satisfaction
Time frame: 2wk, 4wk, 3mo, 6mo
Grip Strength
Time frame: 2wk, 4wk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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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.
Ian A Young, PT principal investigator
Advance Rehab at Fredericksburg Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traction in people with Cervical Radiculopathy, run by Rocky Mountain University of Health Professions 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 1 inclusion and 6 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 25 Jun 2008. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 2wk, 4wk, 3mo, 6mo). The study lists 3 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 25 Jun 2008.