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

Sponsor
University of Mary (Other)
Overall Status
Completed
CT.gov ID
NCT06156605
Collaborator
(none)
55
Enrollment
1
Location
2
Arms
10
Actual Duration (Days)
167.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sidelying lumbar manipulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
Actual Study Start Date :
Sep 18, 2023
Actual Primary Completion Date :
Sep 28, 2023
Actual Study Completion Date :
Sep 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sidelying lumbar manipulation

Right sided lumbar manipulation

Procedure: Sidelying lumbar manipulation
R sided lumbar manipulation
Active Comparator: Sham ultrasound

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

Procedure: Sidelying lumbar manipulation
R sided lumbar manipulation

Outcome Measures

Primary Outcome Measures

  1. Pain pressure threshold [Baseline, Immediately after, 30 minutes after]

    PPT at the right PSIS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Asymptomatic individuals between the ages of 18-50
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 contraindications to manipulation

  • Positive findings during screening precautions

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Mary Bismarck North Dakota United States 58503

Sponsors and Collaborators

  • University of Mary

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew Schumacher, Dr. Schumacher, PT, DPT, OCS, FAAOMPT, University of Mary
ClinicalTrials.gov Identifier:
NCT06156605
Other Study ID Numbers:
  • UMary1234
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Dec 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spinal Injuries

Study Results

No Results Posted as of Dec 5, 2023