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Completed

NCT Number: NCT03863769

Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.

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Key information

Age range

48 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parker University

Dallas, Texas, 75229, United States

About this study

This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age greater than 48 years old
  • Patient has leg or buttock pain while walking
  • Patient feels relief of symptoms with bending (flexing) forward
  • Patient feels relief when using a shopping cart of bicycle
  • Patient has motor or sensory disturbance while walking
  • Patient has normal and symmetrical foot pulses
  • Patient has lower extremity weakness
  • Patient has low back pain
  • Duration of symptoms and signs for more than 1 month
  • Able to stand and walk without assistive devices for at least 20 minutes
  • Able to give written informed consent and complete interviews and questionnaires in English

Exclusion criteria

  • Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy
  • Has other severe co-morbidities, including progressive neurological deficit
  • Other serious pathologies of the locomotor system
  • No correspondence availability through email
  • Inability to read/ comprehend English
  • Compensation or seeking compensation from a third-party liability or workers' compensation
  • Previous spinal manipulation within the past month

Treatment and study plan

Lumbar spinal stenosis

Other

Posture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds).

Primary outcomes

  1. Balance tracking

    Time frame: Each participant will be tested for one minute

    The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).

Secondary outcomes

  1. Questionnaire: Pain sclae

    Time frame: 5 Minutes

    Pain severity of the lower back and buttock using a numerical rating scale (0-10)

  2. Questionnaire: Disability

    Time frame: 5 Minutes

    Stenosis specific disability using the Zurich Claudication Questionnaire; symptom and function. Zurich Claudication Questionnaire has a 7-item symptom severity subscale with scores from 1 to 5 and a 5-item physical function subscale with scores from 1 to 4. The total score range is 12 to 55 points, with higher scores indicating higher levels of self-reported disability.

  3. Questionnaire: Balance

    Time frame: 5 Minutes

    Balance Specific Confidence (ABC-6)

  4. Questionnaire: Change

    Time frame: 5 Minutes

    Patient Global Impression of Change, this 1-item question has a 7-point rating scale with 1 being no change and 7 being considerable improvement.

  5. Sit to Stand

    Time frame: 5 Minutes

    physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.

Sponsors and collaborators

Lead sponsor

Parker University

Other

Collaborators

  • Miami University
  • Private Practice
  • University of Houston
  • Whittier College

Registry information

Official study title

The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.

Acronym: Stenosis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
Jan 14, 2022

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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