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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: spinal manipulative therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: spinal manipulative therapy; refer to arm descriptions
ACTIVE_COMPARATOR: 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.	Procedure: spinal manipulative therapy; refer to arm descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	0 to 100 with 0= no perceived disability to 100= greatest perceived disability	Change in baseline at 2 weeks
Back Performance Scale	0 to 15 with lower scores indicating better performance	Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks
Quantitative Sensory Testing	standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable	change in baseline immediately following spinal manipulative therapy during day 1
Patient Centered Outcome Questionnaire	Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale	change in baseline immediately following spinal manipulative therapy during day 1
Working alliance subscale of the Pain Rehabilitation Expectation Scale	Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance	change in baseline immediately following spinal manipulative therapy during day 1
North American Spine Society Lumbar Spine Outcome Assessment	Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent	2 weeks
Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale	a brief semi- structured interview	2 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Joel E Bialosky, PT, PhD., University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): June 14, 2019
• Study Completion (ACTUAL): June 14, 2019

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (ESTIMATE): June 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB201400928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO