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

University of Florida

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: spinal manipulative therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02476383

IRB201400928

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

augmented spinal manipulative therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: spinal manipulative therapy

neutral spinal manipulative therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: spinal manipulative therapy