Lumbar Spine InjuryLumbarPPTUMaryNCT06156605
Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
A study testing Sidelying lumbar manipulation in people with Lumbar Spine Injury and Pain, run by University of Mary at 1 site in United States.
Trial summary
The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question[s] it aims to answer are: Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group?… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Injury, Pain
- What is being tested?
- Sidelying lumbar manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 28 Sep 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic individuals between the ages of 18-50
Who cannot join
- Current low back pain (LBP)
- A history of low back pain LBP within the last three months
- Previous spinal surgery
- Rheumatological condition or neurological symptoms or conditions
- Recent ingestion of pain-relieving medications within the last 24 hours
- A lumbar manipulation within three days prior to the exam
- Exhibited any contraindications to manipulation
- Positive findings during screening precautions
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question[s] it aims to answer are:
- Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of PPT at the posterior superior iliac spine up to 30 minutes following the intervention.
- Conditions
- Lumbar Spine Injury, Pain
- Being tested
- Sidelying lumbar manipulation
- Medical subject headings
- Spinal Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidelying lumbar manipulationProcedure or surgery
R sided lumbar manipulation
| Study group | Role | What they receive |
|---|---|---|
| Sidelying lumbar manipulation | Experimental | Right sided lumbar manipulation Receives: Procedure: Sidelying lumbar manipulation |
| Sham ultrasound | Active comparator | Sham (non-therapeutic settings) ultrasound at the right PSIS Receives: Procedure: Sidelying lumbar manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
PPT at the right PSIS
Measured: Baseline, Immediately after, 30 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start18 Sep 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
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 Lumbar Spine InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Schumacher, University of Mary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156605
- Sponsor's protocol ID
- UMary1234
- Acronym
- LumbarPPTUMary
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schumacher MR, Swanson C, Wolff S, Orteza R, Aguilar R. Exploring the immediate and short-term effect of lumbar spinal manipulation on pressure pain threshold: a randomized controlled trial of healthy participants. Chiropr Man Therap. 2024 May 29;32(1):19. doi: 10.1186/s12998-024-00540-5.
PubMed 38811985
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT06156605
- Acronym / sponsor ID
- LumbarPPTUMary / UMary1234
- Conditions
- Lumbar Spine Injury, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of MaryUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 5 Dec 2023 (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.
The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question[s] it aims to answer are:
- Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of PPT at the posterior superior iliac spine up to 30 minutes following the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sidelying lumbar manipulation | Experimental | Procedure: Sidelying lumbar manipulationRight sided lumbar manipulation |
| Sham ultrasound | Active comparator | Procedure: Sidelying lumbar manipulationSham (non-therapeutic settings) ultrasound at the right PSIS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic individuals between the ages of 18-50
Key exclusion criteria (8 listed)
- Current low back pain (LBP)
- A history of low back pain LBP within the last three months
- Previous spinal surgery
- Rheumatological condition or neurological symptoms or conditions
- Recent ingestion of pain-relieving medications within the last 24 hours
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 |
|---|---|---|
| Sidelying lumbar manipulationR sided lumbar manipulation | Procedure or surgery | Sham ultrasound, Sidelying lumbar manipulation |
Primary outcome
Pain pressure threshold
Time frame: Baseline, Immediately after, 30 minutes after
PPT at the right PSIS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 38811985Schumacher MR, Swanson C, Wolff S, Orteza R, Aguilar R. Exploring the immediate and short-term effect of lumbar spinal manipulation on pressure pain threshold: a randomized controlled trial of healthy participants. Chiropr Man Therap. 2024 May 29;32(1):19. doi: 10.1186/s12998-024-00540-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sidelying lumbar manipulation in people with Lumbar Spine Injury and Pain, run by University of Mary 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: Baseline, Immediately after, 30 minutes 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 NCT06156605, 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 5 Dec 2023.