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

NCT02476383 | Completed

• 1 other identifier: IRB201400928
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• numeric pain rating scale

  0 to 100 with 0= no pain at all to 100= worst pain imaginable

  Change in baseline at 2 weeks

Secondary Outcomes (7)

• Oswestry Disability Index

  Change in baseline at 2 weeks

• Back Performance Scale

  Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks

• Quantitative Sensory Testing

  change in baseline immediately following spinal manipulative therapy during day 1

• Patient Centered Outcome Questionnaire

  change in baseline immediately following spinal manipulative therapy during day 1

• Working alliance subscale of the Pain Rehabilitation Expectation Scale

  change in baseline immediately following spinal manipulative therapy during day 1

Study Arms (2)

augmented spinal manipulative therapy

ACTIVE COMPARATOR

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.

Procedure: spinal manipulative therapy

neutral spinal manipulative therapy

ACTIVE COMPARATOR

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.

Procedure: spinal manipulative therapy

Interventions

spinal manipulative therapy PROCEDURE

refer to arm descriptions

augmented spinal manipulative therapy; neutral spinal manipulative therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel E Bialosky, PT, PhD.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 19, 2015
• Study Start: September 1, 2015
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)