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

Phase 1

Completed

• Conditions: Low Back Pain
• Interventions: Other: Enhanced sham spinal manipulation; Other: spinal manipulation; Other: sham spinal manipulation

• Registration Number: NCT01168999
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2013-05-10
• Results First Submitted QC: 2013-11-04
• Results First Posted: 2013-12-23
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced sham spinal manipulation	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"
spinal manipulation	spinal manipulation	a spinal manipulation known to be effective in the treatment of low back pain for some individuals
sham spinal manipulation	sham spinal manipulation	a sham spinal manipulation intended to mimic the studied spinal manipulation

Primary Outcome Measures

Name	Time	Method
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale	Change from Baseline at 2 weeks	A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale	baseline and immediately following their assigned intervention during the initial session	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".
Believability of Placebo	baseline	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
Expectation for Treatment Effectiveness	baseline	how helpful participants expect the assigned intervention will be in decreasing their low back pain
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index	Change from Baseline at 2 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States