Low Back PainNCT06294132
Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability
A study testing Lumbar Manipulation in people with Low Back Pain, run by Ithaca College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to 60 years old
- Individuals with mechanical low back pain who have limited spine mobility without signs of nerve root involvement.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ithaca College
Ithaca, New York, 14850
John Winslow, 607-229-8792, jwinslow@ithaca.edu
Michael Costello, mcostello@ithaca.edu
About this study
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,
Read more
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
- Being tested
- Lumbar Manipulation, Sham Lumbar Manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar ManipulationProcedure or surgery
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 ManipulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Mnaipulation | Experimental | Participants will be randomly assigned to receive lumbar manipulation by an experience physical therapist. Receives: Procedure: Lumbar Manipulation |
| Sham Lumbar Manipulation | Sham comparator | Participants will be randomly assigned to receive a sham lumbar manipulation by an experienced physical therapist. Receives: Procedure: Sham Lumbar Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Ultrasound
Sagittal plane ultrasound images of the spinous processes of the lumbar spine and the base of the sacrum will be acquired with the subjects in a sidelying position with the lumbar spine flexed and extended to end-range. Subjects will be imaged with a 5-2 MHZ curvilinear transducer (Edge II MSK ultrasound unit, Sonosite, Inc Bothell, WA). A digital caliper will be used to measure the distance between the spinous process from the peak of the curvature of the caudal spinous process to the peak of the curvature of the cranial spinous process of each lumbar segment (L1-L5). The lumbosacral junction (L5-S1) will be measured from the hyperechoic edge of the sacral base to the peak of the hyperechoic curvature of the L5 spinous process. The examiner will be blinded to the digital caliper measurement and the measurements will be entered into a secure data base by an assistant.
Measured: Immediately prior to intervention and immediately after.
Secondary outcomes (4)
Trunk Flexion Range Of Motion Measurement
A research assistant will have the subject forward bend as far as they feel comfortable and measure the distance from their right middle finge r tip to the floor with a tape measure and record the distance in inches. T his measurement will be repeated three times and the average of the measurement s will be entered into a secure database.
Measured: Immediately prior to intevention and imemditaedly after.
Oswestry Disability Questionnaire
Clinicians and researchers use the Oswestry Disability Questionnaire to quantify disability for low back pain and quality of life. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Scoring level of disability: 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50. Higher scores mean a worse outcome.
Measured: Immediately prior to intervention and one week later.
Numeric Pain Rating Scale
The numeric pain rating scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Higher scores mean a worse outcome.
Measured: Immediately prior to intervention, immediately after, and one week later.
Global Rating of Change
The Global Rating of Change is a scale that assesses whether the subjects condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment. It uses a 15-point Likert scale. Subjects rate their perceived "overall change" on a continuum, with -7 (labeled "worse") on the left and +7 (labeled "better") on the right, and 0 in the middle (labeled "no change"). Lower scores mean a worse outcome.
Measured: Immediately after the intervention and one week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start27 Feb 2024
- Primary completion21 Oct 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ithaca College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294132
- Sponsor's protocol ID
- 4016601
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winslow J, Costello M, Pantina V, Tamburri G, Penhollow R, Milad J, Coffey C, Byers M, Puentedura E. Ultrasound-assessed segmental lumbar motion and clinical outcomes following spinal manipulation: a randomized, controlled pilot study. J Man Manip Ther. 2026 Jul 26:1-9. doi: 10.1080/10669817.2026.2701340. Online ahead of print.
PubMed 42504028
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability
- ClinicalTrials.gov ID
- NCT06294132
- Acronym / sponsor ID
- 4016601
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ithaca CollegeUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 21 Oct 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation.
| Arm | Type | Receives |
|---|---|---|
| Lumbar Mnaipulation | Experimental | Procedure: Lumbar ManipulationParticipants will be randomly assigned to receive lumbar manipulation by an experience physical therapist. |
| Sham Lumbar Manipulation | Sham comparator | Procedure: Sham Lumbar ManipulationParticipants will be randomly assigned to receive a sham lumbar manipulation by an experienced physical therapist. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years old to 60 years old
- Individuals with mechanical low back pain who have limited spine mobility without signs of nerve root involvement.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar ManipulationThe 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. | Procedure or surgery | Lumbar Mnaipulation |
| Sham Lumbar ManipulationThe 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. | Procedure or surgery | Sham Lumbar Manipulation |
Primary outcome
Diagnostic Ultrasound
Time frame: Immediately prior to intervention and immediately after.
Sagittal plane ultrasound images of the spinous processes of the lumbar spine and the base of the sacrum will be acquired with the subjects in a sidelying position with the lumbar spine flexed and extended to end-range. Subjects will be imaged with a 5-2 MHZ curvilinear transducer (Edge II MSK ultrasound unit, Sonosite, Inc Bothell, WA). A digital caliper will be used to measure the distance between the spinous process from the peak of the curvature of the caudal spinous process to the peak of the curvature of the cranial spinous process of each lumbar segment (L1-L5). The lumbosacral junction (L5-S1) will be measured from the hyperechoic edge of the sacral base to the peak of the hyperechoic curvature of the L5 spinous process. The examiner will be blinded to the digital caliper measurement and the measurements will be entered into a secure data base by an assistant.
4 secondary outcomes
Trunk Flexion Range Of Motion Measurement
Time frame: Immediately prior to intevention and imemditaedly after.
Oswestry Disability Questionnaire
Time frame: Immediately prior to intervention and one week later.
Numeric Pain Rating Scale
Time frame: Immediately prior to intervention, immediately after, and one week later.
Global Rating of Change
Time frame: Immediately after the intervention and one week later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 42504028Winslow J, Costello M, Pantina V, Tamburri G, Penhollow R, Milad J, Coffey C, Byers M, Puentedura E. Ultrasound-assessed segmental lumbar motion and clinical outcomes following spinal manipulation: a randomized, controlled pilot study. J Man Manip Ther. 2026 Jul 26:1-9. doi: 10.1080/10669817.2026.2701340. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Manipulation in people with Low Back Pain, run by Ithaca College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Winslow, DPT (6072298792, jwinslow@ithaca.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Ultrasound (time frame: Immediately prior to intervention and immediately after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.