RECRUITING

Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background / Purpose: There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability, Methods: Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI.

Official Title

Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability

Quick Facts

Study Start:2024-02-27
Study Completion:2024-10-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06294132

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years old to 60 years old
  2. * Individuals with mechanical low back pain who have limited spine mobility without signs of nerve root involvement.
  1. * ever had any type of spinal surgery
  2. * ever had a spinal infection
  3. * ever had a fracture in your spine
  4. * recently had an episode of acute physical trauma ie a motor vehicle accident or a fall and - were not evaluated by a medical practitioner.
  5. * are apprehensive about their spine being manipulated
  6. * have osteoporosis or have been on corticosteroids for an extended period of time
  7. * have Rheumatoid Arthritis
  8. * have Marfans Syndrome or Ehlers-Danlos Syndrome
  9. * currently have cancer or any other illness
  10. * have a bleeding disorder or are now on blood thinning medications
  11. * have symptoms of tingling, numbness, or weakness below the knee
  12. * are unable to remain in a sidelying position for at least 30 minutes
  13. * are currently pregnant

Contacts and Locations

Study Contact

John Winslow, DPT
CONTACT
6072298792
jwinslow@ithaca.edu
Michael Costello, Dsc
CONTACT
6073399406
mcostello@ithaca.edu

Study Locations (Sites)

Ithaca College
Ithaca, New York, 14850
United States

Collaborators and Investigators

Sponsor: Ithaca College

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 Registration Dates

Study Start Date2024-02-27
Study Completion Date2024-10-28

Study Record Updates

Study Start Date2024-02-27
Study Completion Date2024-10-28

Terms related to this study

Additional Relevant MeSH Terms

  • Low Back Pain