Recruiting

Lumbar Manipulation

Sponsor:

Ithaca College

Code:

NCT06294132

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Lumbar Manipulation

Sham Lumbar Manipulation

Study Details

Brief summary:

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.

Conditions

Low Back Pain

Study ID

NCT06294132

Start date

Feb 27, 2024

Status verified date

Mar, 2024

Completion date

Oct 28, 2024

Anticipated

Primary completion date

Oct 21, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years old to 60 years old
  • Individuals with mechanical low back pain who have limited spine mobility without signs of nerve root involvement.

Exclusion Criteria:

Subjects cannot participate in this study if they:

  • ever had any type of spinal surgery
  • ever had a spinal infection
  • ever had a fracture in your spine
  • recently had an episode of acute physical trauma ie a motor vehicle accident or a fall and - were not evaluated by a medical practitioner.
  • are apprehensive about their spine being manipulated
  • have osteoporosis or have been on corticosteroids for an extended period of time
  • have Rheumatoid Arthritis
  • have Marfans Syndrome or Ehlers-Danlos Syndrome
  • currently have cancer or any other illness
  • have a bleeding disorder or are now on blood thinning medications
  • have symptoms of tingling, numbness, or weakness below the knee
  • are unable to remain in a sidelying position for at least 30 minutes
  • are currently pregnant

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lumbar Mnaipulation

Participants will be randomly assigned to receive lumbar manipulation by an experience physical therapist.

sham comparator: Sham Lumbar Manipulation

Participants will be randomly assigned to receive a sham lumbar manipulation by an experienced physical therapist.

Interventions

Lumbar Manipulation

The participant lies on the right side. The right leg is straightened at the knee. The left knee is flexed to the level to be manipulated, and the left foot is placed behind the right lower leg. The caregiver introduces rotation of the participant's upper body down to the level to be manipulated. The caregiver then takes up an axillary hold. The caregiver places his right forearm in the region between the gluteus medius and maximus. The caregiver then rolls the participant towards them. Prior to thrusting, the caregiver applies a slight overpressure and holds the position for 10 seconds. If the participant does not experience any adverse effects, over-pressure is released, and the restrictive barrier re=engaged. The caregiver applies a HVLA thrust against the participant's buttocks by dropping their body. If a cavitation "pop" is not heard the first time, a second attempt is made. The procedure is repeated on the opposite side.

Sham Lumbar Manipulation

The participant lies on the right side. The right leg is straightened at the knee. The left knee is flexed SLIGHTLY, and the left foot is placed behind the right lower leg. The caregiver DOES NOT introduce rotation of the participant's upper body down to the level to be manipulated. The caregiver then takes up an axillary hold. The caregiver places his right forearm in the region between the gluteus medius and maximus. The caregiver DOES NOT roll the participant towards them. Prior to thrusting, the caregiver applies a slight overpressure and holds the position for 10 seconds. If the participant does not experience any adverse effects, over-pressure is released, and the restrictive barrier re=engaged. The caregiver applies a HVLA thrust against the participant's buttocks by dropping their body. NO ROTATION OCCURS IN THE SPINE. The procedure is repeated on the opposite side.

Primary outcome measure

  • Diagnostic Ultrasound [ Time Frame: Immediately prior to intervention and immediately after. ]

Central Contacts and Locations

Central contacts

Locations

Ithaca College

Recruiting

Ithaca, New York, United States, 14850

Contacts

More Information

Sponsor

Ithaca College

Last update posted

Mar 8, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ithaca College on 2024-03-08.