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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999
First received: July 22, 2010
Last updated: January 7, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Other: spinal manipulation
Other: sham spinal manipulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Believability of Placebo [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion [ Time Frame: Change from Baseline at 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Low back left sidebending range of motion was measured in degrees using a gravity inclinometer


Enrollment: 110
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: spinal manipulation
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
Other: spinal manipulation
a 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
a 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"

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168999

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Joel Bialosky, PT, PhD University of Florida
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01168999     History of Changes
Other Study ID Numbers: 345-2009
Study First Received: July 22, 2010
Results First Received: May 10, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
low back pain
spinal manipulation
manual therapy
placebo

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014