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

NCT ID: NCT06294132

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-10-28

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lumbar Mnaipulation

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

Group Type: EXPERIMENTAL

Lumbar Manipulation

Intervention Type: PROCEDURE

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

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

Group Type: SHAM_COMPARATOR

Sham Lumbar Manipulation

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ithaca College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ithaca College

Ithaca, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John Winslow, DPT

Role: CONTACT

jwinslow@ithaca.edu

6072298792

Michael Costello, Dsc

Role: CONTACT

mcostello@ithaca.edu

6073399406

Facility Contacts

John Winslow

Role: primary

jwinslow@ithaca.edu

607-229-8792

Michael Costello

Role: backup

mcostello@ithaca.edu

Other Identifiers

4016601

Identifier Type: -

Identifier Source: org_study_id