Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
LumbarPPTUMary
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2023
CompletedFirst Submitted
Initial submission to the registry
November 25, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedDecember 5, 2023
December 1, 2023
10 days
November 25, 2023
December 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pain pressure threshold
PPT at the right PSIS
Baseline, Immediately after, 30 minutes after
Study Arms (2)
Sidelying lumbar manipulation
EXPERIMENTALRight sided lumbar manipulation
Sham ultrasound
ACTIVE COMPARATORSham (non-therapeutic settings) ultrasound at the right PSIS
Interventions
R sided lumbar manipulation
Eligibility Criteria
You may qualify if:
- Asymptomatic individuals between the ages of 18-50
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mary
Bismarck, North Dakota, 58503, United States
Related Publications (1)
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.
PMID: 38811985DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Schumacher, PT, DPT, OCS, FAAOMPT
Study Record Dates
First Submitted
November 25, 2023
First Posted
December 5, 2023
Study Start
September 18, 2023
Primary Completion
September 28, 2023
Study Completion
September 28, 2023
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share