Completed

PRiSMPatient Response to Spinal Manipulation

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What is being tested

HVLA-SM

Other
Who is being recruted

Back Pain+3

+ Neurologic Manifestations

+ Pain

From 21 to 65 Years
+53 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorPalmer College of Chiropractic
Last updated: December 5, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Participants with narrowly defined chronic low back pain will be included in this study. Each participant will be treated 12 times over the course of 6 weeks. The following data will be collected: participant characteristics that may predict outcome or be modifiers of force used by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, and loading rate); physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events. Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research will treat study participants. Each of the study participants will receive 2 High Velocity Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after Spinal Manipulation delivery during treatment visits 1, 5 & 12 (6 sets of assessments in total). During these same treatment visits, we will also capture the kinetic measures during Spinal Manipulation delivery for spinal segment load analysis. Participant patient-centered outcomes will be measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time points will be named as baseline, after 2 weeks, and after 6 weeks.

NCT01670292
Principal SponsorPalmer College of Chiropractic
Last updated: December 5, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain

Criteria

7 inclusion criteria required to participate
Age 21-65

Chronic (12+ weeks) low back pain

Must be >= 2 at phone screen, baseline 1 and baseline 2 visits

Must be >= 4 at the phone screen or baseline 1 visit

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46 exclusion criteria prevent from participating
Ankylosing Spondylytis

BDI-II >= 29

BMI >= 40

Bleeding disorders

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental High Velocity Low Amplitude Spinal Manipulation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Palmer College of Chiropractic

Davenport, United StatesOpen Palmer College of Chiropractic in Google Maps
CompletedOne Study Center