Effectiveness of Therapeutic Exercises on Spinopelvic Mobility

February 17, 2025 updated by: Jason Jennings, Colorado Joint Replacement
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients undergoing revision total hip arthroplasty.
  2. Patients with spinal fusion.
  3. Patients who exercised prior to radiographic analysis.
  4. Patients unable to complete imaging at the designated time of day.
  5. Symptomatic contralateral hip osteoarthritis.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinopelvic Exercise
Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video.
Other: Spinopelvic mobility exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to up to 1 hour after spinopelvic exercises same day.
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.
Change from baseline to up to 1 hour after spinopelvic exercises same day
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.
Change from baseline to up to 1 hour after spinopelvic exercises same day
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)
Change from baseline to up to 1 hour after spinopelvic exercises same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
Hip Society Score
Time Frame: Baseline
Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
Adverse events
Time Frame: Day 1
Any adverse events sustained from therapeutic exercises
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Joint Replacement

Investigators

  • Principal Investigator: Dennis Douglas, MD, Colorado Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2279537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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