The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: spinal manipulation; Other: sham spinal manipulation; Other: Enhanced sham spinal manipulation

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 1

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 which does not extend below the knees
• rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
• appropriate for conservative management of low back pain
• english speaking

Exclusion Criteria:

• surgery to the low back over the past 6 months
• systemic disease known to effect sensation
• other chronic pain condition unrelated to low back pain
• fracture as a cause of low back pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spinal manipulation; a spinal manipulation known to be effective in the treatment of low back pain for some individuals	Other: spinal manipulation; Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
Placebo Comparator: sham spinal manipulation; a sham spinal manipulation intended to mimic the studied spinal manipulation	Other: sham spinal manipulation; Sham spinal manipulation intended to mimic the studied spinal manipulation
No Intervention: natural history; No intervention is provided to participants in this arm of the study
Placebo Comparator: Enhanced sham spinal manipulation; a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"	Other: Enhanced sham spinal manipulation; Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Believability of Placebo	Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT	baseline
Expectation for Treatment Effectiveness	how helpful participants expect the assigned intervention will be in decreasing their low back pain	baseline
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale	A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain	Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index	The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.	Change from Baseline at 2 weeks
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale	Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".	baseline and immediately following their assigned intervention during the initial session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion	Low back flexion range of motion was measured in degrees using a gravity inclinometer	Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion	Low back extension range of motion was measured in degrees using a gravity inclinometer	Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion	Low back right sidebending range of motion was measured in degrees using a gravity inclinometer	Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion	Low back left sidebending range of motion was measured in degrees using a gravity inclinometer	Change from Baseline at 2 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: spinal manipulation; low back pain; placebo; manual therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 345-2009