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

• ClinicalTrials.gov Identifier: NCT01168999
• Recruitment Status: Completed
• First Posted: July 23, 2010
• Results First Posted: December 23, 2013
• Last Update Posted: October 28, 2015
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: July 22, 2010
• First Posted Date: July 23, 2010
• Results First Submitted Date: May 10, 2013
• Results First Posted Date: December 23, 2013
• Last Update Posted Date: October 28, 2015
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2014)

• Believability of Placebo [ Time Frame: 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 [ Time Frame: baseline ]
  how helpful participants expect the assigned intervention will be in decreasing their low back pain
• Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale [ Time Frame: 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 From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index [ Time Frame: 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.
• Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale [ Time Frame: 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".

Original Primary Outcome Measures (submitted: July 22, 2010)

• believability of placebo [ Time Frame: 2 weeks ]
  assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo
• expectation for treatment effectiveness [ Time Frame: 2 weeks ]
  how helpful participants expect the assigned intervention will be in decreasing their low back pain
• clinical pain [ Time Frame: 2 weeks ]
  A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
• disability [ Time Frame: 2 weeks ]
  oswestry functional questionnaire to measure functional limitations related to low back pain
• pain sensitivity [ Time Frame: 2 weeks ]
  self report of pain resulting from standardized thermal and pressure pain stimuli

Current Secondary Outcome Measures (submitted: January 7, 2014)

• Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]
  Low back flexion range of motion was measured in degrees using a gravity inclinometer
• Change From Baseline at 2 Weeks in Low Back Extension Range of Motion [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from Baseline at 2 weeks ]
  Low back left sidebending range of motion was measured in degrees using a gravity inclinometer

Original Secondary Outcome Measures (submitted: July 22, 2010)

low back range of motion and strength [ Time Frame: 2 week ]

measures of low back range of motion and abdominal strength

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
• Official Title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: 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
• Other: sham spinal manipulation
  Sham spinal manipulation intended to mimic the studied spinal manipulation
• 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"

Study Arms

• Active Comparator: spinal manipulation
  a spinal manipulation known to be effective in the treatment of low back pain for some individuals
  Intervention: Other: spinal manipulation
• Placebo Comparator: sham spinal manipulation
  a sham spinal manipulation intended to mimic the studied spinal manipulation
  Intervention: Other: sham 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"
  Intervention: Other: Enhanced sham spinal manipulation

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 4, 2013): 110
• Original Estimated Enrollment (submitted: July 22, 2010): 88
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01168999
• Other Study ID Numbers: 345-2009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Florida
• Original Responsible Party: Joel E Bialosky, PT, PhD, University of Florida
• Current Study Sponsor: University of Florida
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Florida
• Verification Date: October 2015