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Completed

NCT Number: NCT01168999

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Manipulation

Other

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

Other

Sham spinal manipulation intended to mimic the studied spinal manipulation

Enhanced sham spinal manipulation

Other

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"

Primary outcomes

  1. 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

  2. Expectation for Treatment Effectiveness

    Time frame: baseline

    how helpful participants expect the assigned intervention will be in decreasing their low back pain

  3. 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

  4. 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.

  5. 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".

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2010
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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