Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

NCT ID: NCT02476383

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-06-14

Brief Summary

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This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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augmented spinal manipulative therapy

Participants in this group will receive spinal manipulative therapy provided by a practitioner interacting in a warm and friendly way who is free to respond to participant conversation. Participants in this group will receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.

Group Type ACTIVE_COMPARATOR

spinal manipulative therapy

Intervention Type PROCEDURE

refer to arm descriptions

neutral spinal manipulative therapy

Participants in this group will receive spinal manipulative therapy provided by a practitioner engaging in minimal interaction. Participants in this group will not receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.

Group Type ACTIVE_COMPARATOR

spinal manipulative therapy

Intervention Type PROCEDURE

refer to arm descriptions

Interventions

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spinal manipulative therapy

refer to arm descriptions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
* Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
* Appropriate for conservative treatment for low back pain.

Exclusion Criteria

* Non-English speaking;
* Systemic medical conditions know to affect sensation (e.g. diabetes);
* History of lumbar surgery or fracture within the past 6 months;
* Received spinal manipulative therapy for treatment of low back pain within past 6 months;
* Current or history of chronic pain condition other than low back pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel E Bialosky, PT, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201400928

Identifier Type: -

Identifier Source: org_study_id

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