Interventional Study of Effects on Spine Height With Two Unloading Positions

NCT01048749 | Completed DMC

• 1 other identifier: L08-144
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Low Back Pain

Keywords

Low back pain; nerve root compression; spinal height

Outcome Measures

Primary Outcomes (1)

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

  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.

  Pain intensity and location measurements are taken prior to and after completion of each intervention

Study Arms (2)

aquatic vertical supsension

ACTIVE COMPARATOR

Spinal height measurement using a stadiometer following aquatic vertical suspension

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.

Other: land-based supine flexion

Interventions

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.

Also known as: Physical Therapy Treatment

aquatic vertical supsension

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.

Also known as: Physical Therapy Treatment

land-based supine flexion condition

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Cleburne Physical Therapy and Fitness Center

Cleburne, Texas, 76033, United States

Location

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Jean M Brismee, PT, ScD

  Texas Tech University Health Science Center

  STUDY CHAIR

• Susanne M Simmerman, PT, BS

  Texas Tech University Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

US (1)