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NCT Number: NCT06838455

Effectiveness of Therapeutic Exercises on Spinopelvic Mobility

The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.

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Key information

Conditions

Osteoarthritis (OA) of the Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-90 scheduled for total hip arthroplasty
  • Patients with primary hip osteoarthritis
  • Patients with or without history of prior spinal injections

Exclusion criteria

  • Patients undergoing revision total hip arthroplasty.
  • Patients with spinal fusion.
  • Patients who exercised prior to radiographic analysis.
  • Patients unable to complete imaging at the designated time of day.
  • Symptomatic contralateral hip osteoarthritis.
  • Patients unwilling or unable to perform therapeutic exercise program as instructed. This includes patients requiring use of assistive devices or who would be deemed unsafe to perform the exercises without a 1- or 2-person assist.

Treatment and study plan

Spinopelvic mobility exercise

Other

Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. The exercise regimen has been developed by the investigators of this study to incorporate exercises to increase a patient's spinopelvic mobility. Study staff that has been properly trained will be present to guide the patient through the exercise regimen and ensure the exercises are being performed accurately.

Primary outcomes

  1. Spinopelvic radiographic measurements

    Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day.

    Spinopelvic parameter measurements on pre- and post-exercise radiographs including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. All measurements are angles calculated in degrees.

  2. Lumbar mobility

    Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day

    Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs.

  3. Spinopelvic mobility

    Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day

    Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs.

  4. Patient risk classification for THA instability

    Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day

    Risk classification based on previously published risk factors for THA instability (lumbar stiffness, abnormal pelvic mobility, standing pelvic tilt greater than 13, sagittal spinal deformity)

Secondary outcomes

  1. Oswestry Disability Index score

    Time frame: Baseline

    Patient reported outcome for pre-existing back pain and disability. The questionnaire is comprised of 10 sections, where each section is scored on a scale from 0 to 5 and summed. Higher score totals indicates worse disability.

  2. Hip Society Score

    Time frame: Baseline

    Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.

  3. Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)

    Time frame: Baseline

    Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.

  4. The Veterans Rand 12-Item Health Survey scores (VR-12)

    Time frame: Baseline

    Patient reported outcome. Scores are reported as a Z-score that is based on the United States population average of 50. Higher scores indicate better outcomes.

  5. Use of medication for hip/back pain

    Time frame: Baseline

    Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement.

  6. Severity of hip arthritis

    Time frame: Baseline

    Graded using Kellgren-Lawrence scale for osteoarthritis on AP radiographs. Grades are between 0-4, where 0 indicates an absence of osteoarthritis and a 4 indicates severe osteoarthritis.

  7. Adverse events

    Time frame: Day 1

    Any adverse events sustained from therapeutic exercises

Study contacts

Contact information is provided by the study sponsor or research team.

Makenna Hemmerle, MS

CONTACT

[email protected]

3032602951

Sponsors and collaborators

Lead sponsor

Colorado Joint Replacement

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

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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