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Interventional Study of Effects on Spine Height With Two Unloading Positions

T

Texas Tech University Health Sciences Center

Status

Completed

Conditions

Low Back Pain

Treatments

Other: land-based supine flexion
Other: aquatic vertical suspension.

Study type

Interventional

Funder types

Other

Identifiers

NCT01048749
L08-144

Details and patient eligibility

About

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:

  1. 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.
  2. 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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

60 participants in 2 patient groups

aquatic vertical supsension
Active Comparator group
Description:
Spinal height measurement using a stadiometer following aquatic vertical suspension
Treatment:
Other: aquatic vertical suspension.
land-based supine flexion condition
Active Comparator group
Description:
Spine height will be measured with a stadiometer following completion of the supine land-based flexion position.
Treatment:
Other: land-based supine flexion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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