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Interventional Study of Effects on Spine Height With Two Unloading Positions

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aquatic vertical suspension.
land-based supine flexion
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, nerve root compression, spinal height

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Sites / Locations

  • Cleburne Physical Therapy and Fitness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

aquatic vertical supsension

land-based supine flexion condition

Arm Description

Spinal height measurement using a stadiometer following aquatic vertical suspension

Spine height will be measured with a stadiometer following completion of the supine land-based flexion position.

Outcomes

Primary Outcome Measures

Differences of change of spinal height following aquatic vertical suspension compared to lumbar supine flexion positioning.

Secondary Outcome Measures

Differences in pain intensity and location following aquatic vertical suspension compared to supine land-based flexion position.

Full Information

First Posted
January 12, 2010
Last Updated
January 13, 2010
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT01048749
Brief Title
Interventional Study of Effects on Spine Height With Two Unloading Positions
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, nerve root compression, spinal height

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aquatic vertical supsension
Arm Type
Active Comparator
Arm Description
Spinal height measurement using a stadiometer following aquatic vertical suspension
Arm Title
land-based supine flexion condition
Arm Type
Active Comparator
Arm Description
Spine height will be measured with a stadiometer following completion of the supine land-based flexion position.
Intervention Type
Other
Intervention Name(s)
aquatic vertical suspension.
Other Intervention Name(s)
Physical Therapy Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
land-based supine flexion
Other Intervention Name(s)
Physical Therapy Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean M Brismee, PT, ScD
Organizational Affiliation
Texas Tech University Health Science Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susanne M Simmerman, PT, BS
Organizational Affiliation
Texas Tech University Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleburne Physical Therapy and Fitness Center
City
Cleburne
State/Province
Texas
ZIP/Postal Code
76033
Country
United States

12. IPD Sharing Statement

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Interventional Study of Effects on Spine Height With Two Unloading Positions

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