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

December 4, 2023 updated by: Matthew Schumacher, University of Mary

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
        • University of Mary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold
Time Frame: Baseline, Immediately after, 30 minutes after
PPT at the right PSIS
Baseline, Immediately after, 30 minutes after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMary1234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Sidelying lumbar manipulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe