SciaticaPhase 3NCT00942227
The Value of Traction in Treatment of Lumbar Radiculopathy
A Phase 3 study testing Physical therapy rehabilitation in people with Sciatica and Radiculopathy, run by Intermountain Health Care, Inc. at 1 site 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 low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sciatica, Radiculopathy, Spinal Diseases
- What is being tested?
- Physical therapy rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- Oswestry disability score of at least 20%
- Age at least 18 years and less than 60 years
- At least one of the following signs of nerve root compression:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
- Sensory deficit to pinprick on the ipsilateral lower extremity
- Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
Who cannot join
- Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- Patient reports the complete absence of low back and leg symptoms when seated
- Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
- Current pregnancy
- Inability to comply with the treatment schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare, Rehab Agency
Salt Lake City, Utah, 84119
About this study
Official title: The Value of Traction in Treatment of Lumbar Radiculopathy.
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.
Read the detailed description
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
- Conditions
- Sciatica, Radiculopathy, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement
- Being tested
- Physical therapy rehabilitation
- Keywords
- Sciatica, Radiculopathy, Physical therapy modalities, Rehabilitation
- Medical subject headings
- Sciatica, Radiculopathy, 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 McKenzie exercises, Directional preference, Specific exercise
Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Physical therapy rehabilitationOther
Also called Saunders 3D Active Trac
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine. Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Extension oriented treatment approach | Active comparator | Extension exercises. Subjects are instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to further increase extension movement and/or reduction of symptoms. Receives: Other: Physical therapy rehabilitation |
| Mechanical traction plus extension-oriented treatment | Experimental | Mechanical lumbar traction will be utilized in addition to extension oriented exercises. Subjects are also instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to increase extension movement and/or reduce radicular symptoms. Receives: Other: Physical therapy rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measured: Baseline, 6 weeks, 6 months, 1year
Secondary outcomes (1)
Global Rating of Change
Measured: Baseline, 6 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 posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies 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
- 120 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, Julie Fritz, Intermountain Health Care, Inc.
- Investigators
- Julie M Fritz, PhD, Principal investigator, Intermountain Healthcare; University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942227
- Sponsor's protocol ID
- 1008586
- Status last verified
- Jan 2013
- First submitted
- 16 Jul 2009
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
PubMed 26813755Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.
PubMed 20433733
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Traction in Treatment of Lumbar Radiculopathy.
- ClinicalTrials.gov ID
- NCT00942227
- Acronym / sponsor ID
- 1008586
- Conditions
- Sciatica, Radiculopathy, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement
- Keywords
- Sciatica, Radiculopathy, Physical therapy modalities, Rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 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
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jul 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 low back pain.
Detailed description
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extension oriented treatment approach | Active comparator | Other: Physical therapy rehabilitationExtension exercises. Subjects are instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to further increase extension movement and/or reduction of symptoms. |
| Mechanical traction plus extension-oriented treatment | Experimental | Other: Physical therapy rehabilitationMechanical lumbar traction will be utilized in addition to extension oriented exercises. Subjects are also instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to increase extension movement and/or reduce radicular symptoms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- Oswestry disability score of at least 20%
- Age at least 18 years and less than 60 years
- At least one of the following signs of nerve root compression:
Key exclusion criteria (7 listed)
- Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- Patient reports the complete absence of low back and leg symptoms when seated
- Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
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: McKenzie exercises, Directional preference, Specific exerciseExtension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine | Other | Extension oriented treatment approach |
| Physical therapy rehabilitationAlso: Saunders 3D Active TracMechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine. Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group. | Other | Mechanical traction plus extension-oriented treatment |
Primary outcome
Oswestry Disability Index
Time frame: Baseline, 6 weeks, 6 months, 1year
1 secondary outcome
Global Rating of Change
Time frame: Baseline, 6 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 14 Jan 2013.
- Derived from this study: PubMed 26813755Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
- Derived from this study: PubMed 20433733Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.
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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 M Fritz, PhD principal investigator
Intermountain Healthcare; University of Utah
1 site 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 Sciatica and Radiculopathy, run by Intermountain Health Care, Inc. 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 8 inclusion and 7 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 14 Jan 2013. 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.
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?
Oswestry Disability Index (time frame: Baseline, 6 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 NCT00942227, which also lists 2 linked publications.
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 14 Jan 2013.