ClinicalTrials.gg
CompletedNCT06156605LumbarPPTUMaryUpdated Dec 5, 2023

Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals

An interventional study of Sidelying lumbar manipulation in Lumbar Spine Injury and Pain, sponsored by University of Mary. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by University of Mary · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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? 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.
02

Conditions studied

  • Lumbar Spine Injury
  • Pain
03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's enrollment of 55 is close to the median of 52 across 31 interventional studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

This is the only study on the registry with University of Mary as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Asymptomatic individuals between the ages of 18-50

Exclusion criteria

Exclusion Criteria:

  • 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 to manipulation
  • Positive findings during screening precautions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Sidelying lumbar manipulation

    Right sided lumbar manipulation

    Procedure: Sidelying lumbar manipulation

  • Active comparator
    Sham ultrasound

    Sham (non-therapeutic settings) ultrasound at the right PSIS

    Procedure: Sidelying lumbar manipulation

Interventions

  • ProcedureSidelying lumbar manipulation

    R sided lumbar manipulation

06

What researchers measure

Primary outcomes

  1. Pain pressure threshold

    PPT at the right PSIS

    Time frame: Baseline, Immediately after, 30 minutes after

07

Study locations

1 site
  • University of Mary
    Bismarck, North Dakota 58503, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06156605
Lead sponsor
University of Mary
Responsible party
Matthew Schumacher (Dr. Schumacher, PT, DPT, OCS, FAAOMPT, University of Mary) — Principal investigator
First posted
Dec 5, 2023
Start date
Sep 18, 2023
Primary completion
Sep 28, 2023
Completion
Sep 28, 2023
Last update
Dec 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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