Low Back PainNCT01048749
Interventional Study of Effects on Spine Height With Two Unloading Positions
A study testing aquatic vertical suspension. and land-based supine flexion in people with Low Back Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study is to test a physical therapy intervention for reducing pain in the low back and into the legs. With individuals over the age of 40 years, this pain may be associated to changes in back height from aging of the cushions between the back bones. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- aquatic vertical suspension. and land-based supine flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2009
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 40-80 years,
- have current low back pain and/or numbness extending distal to the buttocks in the past 24 hours,
- pain level < 7/10 on the numerical rating scale, including symptom location change or pain intensity change with extension, lower limb weakness, achilles or patella reflex changes,
- reduction of lower limb sensation,
- positive SLR test.
Who cannot join
- inability to walk for a minimum of 15 minutes,
- inability to sit for a minimum of 5 minutes,
- inability to lie supine for a minimum of 15 minutes,
- fear of water or unwillingness to enter into a deep pool,
- allergy to chlorine,
- neurological disorders such as multiple sclerosis, spinal cord injury, incontinence, or spinal fusion,
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- inability to elevate either shoulder above 90 degrees,
- pregnancy,
- vertebral fracture,
- pain level above 7/10 on the numeric pain scale or pain level reported at 0/10.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleburne Physical Therapy and Fitness Center
Cleburne, Texas, 76033
About this study
Official title: Immediate Changes in Spinal Height and Pain Following Aquatic Vertical Suspension in Patients With Low Back Pain and Signs of Nerve Root Compression
The purpose of this study is to test a physical therapy intervention for reducing pain in the low back and into the legs. With individuals over the age of 40 years, this pain may be associated to changes in back height from aging of the cushions between the back bones. When pain is caused from this, completion of different positions and rest periods have been shown to help reduce the pain, at least temporarily. This study will compare two such positions; 1)floating in deep warm water with weights attached to the ankles, to take the load off of the spine, 2)lying on their back with hip and knees flexed to a 90 degree angle. The height of each person will be measured before and after completion of each intervention using a specially designed measuring tool.
Experimental hypothesis:
- Subjects with low back and leg pain suggestive of nerve root compression syndrome will experience increase in spinal height when completing aquatic vertical suspension and/or land-based supine flexion.
- Subjects with low back and leg pain suggestive of nerve root compression syndrome will experience greater increase in height, greater reduction of pain intensity and location when completing underwater vertical suspension as compared to supine land based flexion.
Read the detailed description
Spinal height is affected throughout life from many different physiological changes and mechanical stresses, but a large portion is thought to occur primarily from intervertebral disc degeneration with resultant reduction in overall spinal height. The use of specific postures and rest periods to increase the overall spinal height has been suggested through various stadiometric research studies. This overall spinal height change can be used as a treatment tool for management of symptoms of chronic low back pain and signs of nerve root compression.
The purpose of the study is to investigate the effect of aquatic vertical suspension on spinal height, symptom location and pain intensity compared to a more commonly used land based supine flexion position.
The study will be conducted at one outpatient physical therapy clinic with subjects recruited from the local community.
A single blinded True Experimental Repeated Measure cross over design will be utilized.
Spine height will be measured using a commercially available stadiometer. Spinal height measurements will be completed after loaded walking, supine land based flexion positioning and after aquatic vertical hang.
- Conditions
- Low Back Pain
- Being tested
- aquatic vertical suspension., land-based supine flexion
- Keywords
- Low back pain, nerve root compression, spinal height
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic vertical suspension.Other
Also called Physical Therapy Treatment
Subject is suspended in a warm water deep pool with two pool noodles around the subject and directly under the axilla. Five pound weights are placed on the ankle and the subject maintains this unloaded position for 15 minutes.
land-based supine flexionOther
Also called Physical Therapy Treatment
The subject will lay supine with the legs supported by a foam wedge with hips flexed to 90 degrees and knees flexed to 65 degrees. They will maintain this unloaded position for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| aquatic vertical supsension | Active comparator | Spinal height measurement using a stadiometer following aquatic vertical suspension Receives: Other: aquatic vertical suspension. |
| land-based supine flexion condition | Active comparator | Spine height will be measured with a stadiometer following completion of the supine land-based flexion position. Receives: Other: land-based supine flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of change of spinal height following aquatic vertical suspension compared to lumbar supine flexion positioning.
Measured: Spine height is measured prior to and after each intervention and then statistical comparisons completed.
Secondary outcomes (1)
Differences in pain intensity and location following aquatic vertical suspension compared to supine land-based flexion position.
Measured: Pain intensity and location measurements are taken prior to and after completion of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Investigators
- Jean M Brismee, PT, ScD, Study chair, Texas Tech University Health Sciences CenterSusanne M Simmerman, PT, BS, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048749
- Sponsor's protocol ID
- L08-144
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Changes in Spinal Height and Pain Following Aquatic Vertical Suspension in Patients With Low Back Pain and Signs of Nerve Root Compression
- ClinicalTrials.gov ID
- NCT01048749
- Acronym / sponsor ID
- L08-144
- Conditions
- Low Back Pain
- Keywords
- Low back pain, nerve root compression, spinal height
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Jan 2010 (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 test a physical therapy intervention for reducing pain in the low back and into the legs. With individuals over the age of 40 years, this pain may be associated to changes in back height from aging of the cushions between the back bones. When pain is caused from this, completion of different positions and rest periods have been shown to help reduce the pain, at least temporarily. This study will compare two such positions; 1)floating in deep warm water with weights attached to the ankles, to take the load off of the spine, 2)lying on their back with hip and knees flexed to a 90 degree angle. The height of each person will be measured before and after completion of each intervention using a specially designed measuring tool.
Experimental hypothesis:
- Subjects with low back and leg pain suggestive of nerve root compression syndrome will experience increase in spinal height when completing aquatic vertical suspension and/or land-based supine flexion.
- Subjects with low back and leg pain suggestive of nerve root compression syndrome will experience greater increase in height, greater reduction of pain intensity and location when completing underwater vertical suspension as compared to supine land based flexion.
Detailed description
Spinal height is affected throughout life from many different physiological changes and mechanical stresses, but a large portion is thought to occur primarily from intervertebral disc degeneration with resultant reduction in overall spinal height. The use of specific postures and rest periods to increase the overall spinal height has been suggested through various stadiometric research studies. This overall spinal height change can be used as a treatment tool for management of symptoms of chronic low back pain and signs of nerve root compression.
The purpose of the study is to investigate the effect of aquatic vertical suspension on spinal height, symptom location and pain intensity compared to a more commonly used land based supine flexion position.
The study will be conducted at one outpatient physical therapy clinic with subjects recruited from the local community.
A single blinded True Experimental Repeated Measure cross over design will be utilized.
Spine height will be measured using a commercially available stadiometer. Spinal height measurements will be completed after loaded walking, supine land based flexion positioning and after aquatic vertical hang.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aquatic vertical supsension | Active comparator | Other: aquatic vertical suspension.Spinal height measurement using a stadiometer following aquatic vertical suspension |
| land-based supine flexion condition | Active comparator | Other: land-based supine flexionSpine height will be measured with a stadiometer following completion of the supine land-based flexion position. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the ages of 40-80 years,
- have current low back pain and/or numbness extending distal to the buttocks in the past 24 hours,
- pain level < 7/10 on the numerical rating scale, including symptom location change or pain intensity change with extension, lower limb weakness, achilles or patella reflex changes,
- reduction of lower limb sensation,
- positive SLR test.
Key exclusion criteria (10 listed)
- inability to walk for a minimum of 15 minutes,
- inability to sit for a minimum of 5 minutes,
- inability to lie supine for a minimum of 15 minutes,
- fear of water or unwillingness to enter into a deep pool,
- allergy to chlorine,
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 |
|---|---|---|
| aquatic vertical suspension.Also: Physical Therapy TreatmentSubject is suspended in a warm water deep pool with two pool noodles around the subject and directly under the axilla. Five pound weights are placed on the ankle and the subject maintains this unloaded position for 15 minutes. | Other | aquatic vertical supsension |
| land-based supine flexionAlso: Physical Therapy TreatmentThe subject will lay supine with the legs supported by a foam wedge with hips flexed to 90 degrees and knees flexed to 65 degrees. They will maintain this unloaded position for 15 minutes. | Other | land-based supine flexion condition |
Primary outcome
Differences of change of spinal height following aquatic vertical suspension compared to lumbar supine flexion positioning.
Time frame: Spine height is measured prior to and after each intervention and then statistical comparisons completed.
1 secondary outcome
Differences in pain intensity and location following aquatic vertical suspension compared to supine land-based flexion position.
Time frame: Pain intensity and location measurements are taken prior to and after completion of each 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 14 Jan 2010.
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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.
Jean M Brismee, PT, ScD study chair
Texas Tech University Health Sciences Center
Susanne M Simmerman, PT, BS principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic vertical suspension. and land-based supine flexion in people with Low Back Pain, run by Texas Tech University Health Sciences Center 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 5 inclusion and 10 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 2010. 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?
Differences of change of spinal height following aquatic vertical suspension compared to lumbar supine flexion positioning. (time frame: Spine height is measured prior to and after each intervention and then statistical comparisons completed.). 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 14 Jan 2010.