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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168999
• Other study ID #: 345-2009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 22, 2010
• Last updated: October 5, 2015
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: October 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• sham spinal manipulation
Sham spinal manipulation intended to mimic the studied spinal manipulation
• 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"

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Expectation for Treatment Effectiveness	how helpful participants expect the assigned intervention will be in decreasing their low back pain	baseline	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No