RadiculopathyPhase 3NCT00979108
The Value of Traction in the Treatment of Cervical Radiculopathy
A Phase 3 study testing Physical therapy rehabilitation in people with Radiculopathy and Neck Pain, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiculopathy, Neck Pain, Spinal Diseases
- What is being tested?
- Physical therapy rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jan 2013
- Phase
- Phase 3
- 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
- Primary complaint of neck pain with symptoms (pain and/or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula (may be unilateral or bilateral).
- Age between 18-70 years old
- Neck Disability Score score >10 points
Who cannot join
- Red flags indicative of a serious or non-musculoskeletal condition (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Diagnosis of cervical spinal stenosis based on CT or MRI imaging
- Evidence of cervical myelopathy or central nervous system involvement, (e.g., hyperreflexia, intrinsic muscle wasting of the hands, unsteadiness during gait, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathologic reflexes (i.e. positive Hoffman's or Babinski reflex).
- Prior surgery to the neck or thoracic spine
- Inability to comply with treatment and follow-up schedule
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78235
Intermountain Healthcare, Rehab Agency
Salt Lake City, Utah, 84119
About this study
Official title: The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain.
Read the detailed description
Cervical traction is an intervention frequently recommended for the treatment of patients with neck pain. Systematic reviews have not endorsed the use of mechanical traction for patients with neck pain, however these reviews note the poor methodological quality of available research. Trials that have been performed have examined heterogeneous samples of patients with neck pain. It may be that cervical traction has not shown to be effective because only a specific subgroup may benefit from it. Most experts believe that traction is most beneficial for individuals with neck pain extending into the upper extremity who have signs of nerve root compression. Randomized clinical trials examining the effectiveness of traction for patients with these specific characteristics have not been performed. Preliminary studies support the hypothesis that there exists a specific subgroup of patients with neck pain likely to benefit from traction
The current study will address 3 important questions:
- Will the existence of a more specific subgroup of patients who benefit from traction along with a standard exercise program be validated in a second sample of patients?
- Is cervical traction a critical component of the treatment necessary to maximize outcomes for patients in this subgroup?
- Do two commonly used traction protocols differ in their effectiveness for patients in this subgroup? (Specifically, we study will compare supine mechanical traction to over-the-door traction.)
- Conditions
- Radiculopathy, Neck Pain, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement
- Being tested
- Physical therapy rehabilitation
- Keywords
- Radiculopathy, Neck pain, Physical therapy modalities, Rehabilitation
- Medical subject headings
- Radiculopathy, Neck Pain, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy rehabilitationOther
Also called Saunders 3D Active Trac
Mechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises.
Physical therapy rehabilitationOther
Subjects will be instructed in use of an over-the-door traction unit utilizing weights up to 20 pounds in sitting. In addition, subjects will be trained in neck and postural exercises.
Physical therapy rehabilitationOther
Subjects will be instructed in neck and postural exercises.
| Study group | Role | What they receive |
|---|---|---|
| Standard exercise | Active comparator | Subjects will be instructed in neck and postural exercises. Receives: Other: Physical therapy rehabilitation |
| Over-door traction and exercise. | Experimental | Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises. Receives: Other: Physical therapy rehabilitation |
| Mechanical traction and exercise | Experimental | Mechanical cervical traction will be utilized in addition to neck and postural exercises. Receives: Other: Physical therapy rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Questionnaire
Measured: Baseline, 4 weeks, 6 months, 1year
Secondary outcomes (1)
Global Rating of Change
Measured: Baseline, 4 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, 59th Medical Wing, Empi, A DJO Company
- Responsible party
- Principal investigator, Shauna Bruun, Intermountain Health Care, Inc.
- Investigators
- Julie Fritz, Principal investigator, IHC Health Services, Inc., Dba: TOSH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979108
- Sponsor's protocol ID
- 1009133
- Status last verified
- Nov 2014
- First submitted
- 16 Sep 2009
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fritz JM, Thackeray A, Brennan GP, Childs JD. Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):45-57. doi: 10.2519/jospt.2014.5065. Epub 2014 Jan 9.
PubMed 24405257
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Mechanical Traction in the Treatment of Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT00979108
- Acronym / sponsor ID
- 1009133
- Conditions
- Radiculopathy, Neck Pain, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement
- Keywords
- Radiculopathy, Neck pain, Physical therapy modalities, Rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah, 59th Medical Wing, Empi, A DJO Company
- Study start
- Jul 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Sep 2009 (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.
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain.
Detailed description
Cervical traction is an intervention frequently recommended for the treatment of patients with neck pain. Systematic reviews have not endorsed the use of mechanical traction for patients with neck pain, however these reviews note the poor methodological quality of available research. Trials that have been performed have examined heterogeneous samples of patients with neck pain. It may be that cervical traction has not shown to be effective because only a specific subgroup may benefit from it. Most experts believe that traction is most beneficial for individuals with neck pain extending into the upper extremity who have signs of nerve root compression. Randomized clinical trials examining the effectiveness of traction for patients with these specific characteristics have not been performed. Preliminary studies support the hypothesis that there exists a specific subgroup of patients with neck pain likely to benefit from traction
The current study will address 3 important questions:
- Will the existence of a more specific subgroup of patients who benefit from traction along with a standard exercise program be validated in a second sample of patients?
- Is cervical traction a critical component of the treatment necessary to maximize outcomes for patients in this subgroup?
- Do two commonly used traction protocols differ in their effectiveness for patients in this subgroup? (Specifically, we study will compare supine mechanical traction to over-the-door traction.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard exercise | Active comparator | Other: Physical therapy rehabilitationSubjects will be instructed in neck and postural exercises. |
| Over-door traction and exercise. | Experimental | Other: Physical therapy rehabilitationSubjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises. |
| Mechanical traction and exercise | Experimental | Other: Physical therapy rehabilitationMechanical cervical traction will be utilized in addition to neck and postural exercises. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary complaint of neck pain with symptoms (pain and/or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula (may be unilateral or bilateral).
- Age between 18-70 years old
- Neck Disability Score score >10 points
Key exclusion criteria (5 listed)
- Red flags indicative of a serious or non-musculoskeletal condition (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Diagnosis of cervical spinal stenosis based on CT or MRI imaging
- Evidence of cervical myelopathy or central nervous system involvement, (e.g., hyperreflexia, intrinsic muscle wasting of the hands, unsteadiness during gait, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathologic reflexes (i.e. positive Hoffman's or Babinski reflex).
- Prior surgery to the neck or thoracic spine
- Inability to comply with treatment and follow-up schedule
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 |
|---|---|---|
| Physical therapy rehabilitationAlso: Saunders 3D Active TracMechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises. | Other | Mechanical traction and exercise |
| Physical therapy rehabilitationSubjects will be instructed in use of an over-the-door traction unit utilizing weights up to 20 pounds in sitting. In addition, subjects will be trained in neck and postural exercises. | Other | Over-door traction and exercise. |
| Physical therapy rehabilitationSubjects will be instructed in neck and postural exercises. | Other | Standard exercise |
Primary outcome
Neck Disability Questionnaire
Time frame: Baseline, 4 weeks, 6 months, 1year
1 secondary outcome
Global Rating of Change
Time frame: Baseline, 4 weeks, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Results publication: PubMed 24405257Fritz JM, Thackeray A, Brennan GP, Childs JD. Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):45-57. doi: 10.2519/jospt.2014.5065. Epub 2014 Jan 9.
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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.
Julie Fritz principal investigator
IHC Health Services, Inc., Dba: TOSH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physical therapy rehabilitation in people with Radiculopathy and Neck Pain, run by Intermountain Health Care, Inc. at 2 sites 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 5 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: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Questionnaire (time frame: Baseline, 4 weeks, 6 months, 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979108, which also lists 1 linked publication.
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 17 Nov 2014.