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Completed

NCT Number: NCT01048749

Interventional Study of Effects on Spine Height With Two Unloading Positions

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.

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleburne Physical Therapy and Fitness Center

Cleburne, Texas, 76033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aquatic vertical suspension.

Other

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.

Other names: Physical Therapy Treatment

land-based supine flexion

Other

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.

Other names: Physical Therapy Treatment

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Immediate Changes in Spinal Height and Pain Following Aquatic Vertical Suspension in Patients With Low Back Pain and Signs of Nerve Root Compression

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2010
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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