Low Back PainNCT02026076
Manual Unloading of the Lumbar Spine: Can it Predict Responders to Mechanical Traction?
A study testing mechanical lumbar traction in people with Low Back Pain, run by UConn Health at 1 site in United States.
Trial summary
This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the immediate response to traction can be determined by using a simple unloading test in standing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- mechanical lumbar traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18-75
- non-radicular low back pain (LBP)
Who cannot join
- tumor,
- fracture,
- infectious disorder,
- central nervous system involvement,
- presence of medical red flags,
- absence of LBP,
Show all 12Show fewer
- radicular leg pain (below the knee),
- pregnancy,
- epidural steroid injection within 4 weeks prior to study involvement,
- previous back surgery,
- workers compensation involvement
- active litigation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Manual Unloading of the Lumbar Spine: Can it Predict Response to Mechanical Traction? A Study or Reliability and Criterion Referenced Predictive Validity
This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the immediate response to traction can be determined by using a simple unloading test in standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low back pain which does not travel below the knee. All subjects will rate their pain on a 100 mm line both at rest and in their most painful direction of movement. A therapist will then unload the patients spine to determine if they feel any relief. All subjects will then undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50% body weight. Following traction, all subjects will again rate their pain on a 100 mm line. Subjects will be grouped by response to the initial manual unloading test and assessed for within and between group differences. The study hypothesis is that the manual unloading test is reliable, and that responders to mechanical traction can be accurately identified using a manual unloading test.
Read the detailed description
This study will consist of two distinct components. Part one will be a reliability study of manual unloading. Two therapists, both familiar with the technique of manual unloading as described by Kaltenborn17, will perform a manual unloading test, blinded to the previous results. Ten consecutive patients will be recruited from a sample of convenience at the University Of Connecticut Health Center Department Of Rehabilitation. This test will be repeated on the same subjects within 7 days of initial testing. Tests of agreement will then be applied to determine intra and inter-rater reliability.
Part two will consist of a trial of lumbar traction in a group of subjects with low back pain without radiculopathy, anticipated n=30. At the time of enrollment, all subjects will complete a standardized informed consent form, detailing all potential risks of the trail. Consent will include permission for demographic data to be obtained from the standard intake form, and kept in a de-identified form in a secure location. All subjects will complete a screening form, which will ensure that the potential subjects do not have any of the excluding factors present. Prior to enrollment, all subjects will complete a standardized medical history form (kept as part of the medical record for all patients), as part of standard departmental practice. Additionally, participants will complete a modified Oswestry questionnaire as well as two 100 mm visual analog scales (VAS), one indicating pain at rest, the other indicating pain in their most provocative test motion (flexion, extension, or side flexion of the lumbar spine). Subjects will then be tested with unloading in standing as described by Kaltenborn. This test involves the therapist applying a low grade lifting force to the patient in a standing position, testing for symptomatic alleviation via the elimination of compression on pain sensitive structures. Results of this test will be coded as (+) relief or (-) relief. Prior to traction application, subjects will undergo a standardized, comprehensive examination (standard of care), which will include screening for exclusion criteria (myotomal weakness, sensation changes, positive neural tension signs). All subjects will be weighed prior to traction application to determine treatment force to be generated. To aid in determining BMI, subjects will also have their height measured. The reference test will consist of a single application of mechanical traction, 15 minutes, 30 seconds on/ 10 seconds off, at 50% of body weight with the treatment table in the opened position, while positioned in a supine, hook lying neutral posture. Post traction, all subjects will repeat AROM measures, and complete a second pair of VAS to determine immediate effect of the intervention.
- Conditions
- Low Back Pain
- Being tested
- mechanical lumbar traction
- Keywords
- low back pain, traction, unloading
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical lumbar tractionOther
15 minutes at up to 50% body weight lumbar traction in supine hooklying with split table open
| Study group | Role | What they receive |
|---|---|---|
| manual unloading | Experimental | All subjects will first undergo a manual unloading test, followed by a single application of mechanical lumbar traction to determine predictive effect Receives: Other: mechanical lumbar traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog pain scale in the most provocative movement
Measured: immediate post intervention (within 5 minutes following intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Andrews University
- Responsible party
- Sponsor
- Investigators
- Isaac Moss, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026076
- Sponsor's protocol ID
- Manual Unloading
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Unloading of the Lumbar Spine: Can it Predict Response to Mechanical Traction? A Study or Reliability and Criterion Referenced Predictive Validity
- ClinicalTrials.gov ID
- NCT02026076
- Acronym / sponsor ID
- Manual Unloading
- Conditions
- Low Back Pain
- Keywords
- low back pain, traction, unloading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Andrews University
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Jan 2014 (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.
This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the immediate response to traction can be determined by using a simple unloading test in standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low back pain which does not travel below the knee. All subjects will rate their pain on a 100 mm line both at rest and in their most painful direction of movement. A therapist will then unload the patients spine to determine if they feel any relief. All subjects will then undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50% body weight. Following traction, all subjects will again rate their pain on a 100 mm line. Subjects will be grouped by response to the initial manual unloading test and assessed for within and between group differences. The study hypothesis is that the manual unloading test is reliable, and that responders to mechanical traction can be accurately identified using a manual unloading test.
Detailed description
This study will consist of two distinct components. Part one will be a reliability study of manual unloading. Two therapists, both familiar with the technique of manual unloading as described by Kaltenborn17, will perform a manual unloading test, blinded to the previous results. Ten consecutive patients will be recruited from a sample of convenience at the University Of Connecticut Health Center Department Of Rehabilitation. This test will be repeated on the same subjects within 7 days of initial testing. Tests of agreement will then be applied to determine intra and inter-rater reliability.
Part two will consist of a trial of lumbar traction in a group of subjects with low back pain without radiculopathy, anticipated n=30. At the time of enrollment, all subjects will complete a standardized informed consent form, detailing all potential risks of the trail. Consent will include permission for demographic data to be obtained from the standard intake form, and kept in a de-identified form in a secure location. All subjects will complete a screening form, which will ensure that the potential subjects do not have any of the excluding factors present. Prior to enrollment, all subjects will complete a standardized medical history form (kept as part of the medical record for all patients), as part of standard departmental practice. Additionally, participants will complete a modified Oswestry questionnaire as well as two 100 mm visual analog scales (VAS), one indicating pain at rest, the other indicating pain in their most provocative test motion (flexion, extension, or side flexion of the lumbar spine). Subjects will then be tested with unloading in standing as described by Kaltenborn. This test involves the therapist applying a low grade lifting force to the patient in a standing position, testing for symptomatic alleviation via the elimination of compression on pain sensitive structures. Results of this test will be coded as (+) relief or (-) relief. Prior to traction application, subjects will undergo a standardized, comprehensive examination (standard of care), which will include screening for exclusion criteria (myotomal weakness, sensation changes, positive neural tension signs). All subjects will be weighed prior to traction application to determine treatment force to be generated. To aid in determining BMI, subjects will also have their height measured. The reference test will consist of a single application of mechanical traction, 15 minutes, 30 seconds on/ 10 seconds off, at 50% of body weight with the treatment table in the opened position, while positioned in a supine, hook lying neutral posture. Post traction, all subjects will repeat AROM measures, and complete a second pair of VAS to determine immediate effect of the intervention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| manual unloading | Experimental | Other: mechanical lumbar tractionAll subjects will first undergo a manual unloading test, followed by a single application of mechanical lumbar traction to determine predictive effect |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages 18-75
- non-radicular low back pain (LBP)
Key exclusion criteria (12 listed)
- tumor,
- fracture,
- infectious disorder,
- central nervous system involvement,
- presence of medical red flags,
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 |
|---|---|---|
| mechanical lumbar traction15 minutes at up to 50% body weight lumbar traction in supine hooklying with split table open | Other | manual unloading |
Primary outcome
Change in Visual Analog pain scale in the most provocative movement
Time frame: immediate post intervention (within 5 minutes following intervention)
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 1 Jan 2014.
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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.
Isaac Moss, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical lumbar traction in people with Low Back Pain, run by UConn Health 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 2 inclusion and 12 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 1 Jan 2014. 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?
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?
Change in Visual Analog pain scale in the most provocative movement (time frame: immediate post intervention (within 5 minutes following intervention)). 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 1 Jan 2014.