NCT01168999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1 low-back-pain

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 23, 2013

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

July 22, 2010

Results QC Date

May 10, 2013

Last Update Submit

October 5, 2015

Conditions

Low Back Pain

Keywords

low back painspinal manipulationmanual therapyplacebo

Outcome Measures

Primary Outcomes (5)

  • 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

  • Expectation for Treatment Effectiveness

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

    baseline

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion

    Change from Baseline at 2 weeks

  • Change From Baseline at 2 Weeks in Low Back Extension Range of Motion

    Change from Baseline at 2 weeks

  • Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion

    Change from Baseline at 2 weeks

  • Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion

    Change from Baseline at 2 weeks

Study Arms (4)

spinal manipulation

ACTIVE COMPARATOR

a spinal manipulation known to be effective in the treatment of low back pain for some individuals

Other: spinal manipulation

sham spinal manipulation

PLACEBO COMPARATOR

a sham spinal manipulation intended to mimic the studied spinal manipulation

Other: sham spinal manipulation

natural history

NO INTERVENTION

No intervention is provided to participants in this arm of the study

Enhanced sham spinal manipulation

PLACEBO COMPARATOR

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"

Other: Enhanced sham spinal manipulation

Interventions

spinal manipulationOTHER

Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain

spinal manipulation
sham spinal manipulationOTHER

Sham spinal manipulation intended to mimic the studied spinal manipulation

sham spinal manipulation
Enhanced sham spinal manipulationOTHER

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"

Enhanced sham spinal manipulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 24361109DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Results Point of Contact

Title
Dr. Joel Bialosky
Organization
University of Florida
bialosky@phhp.ufl.edu
352-273-8636

Study Officials

  • Joel Bialosky, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 28, 2015

Results First Posted

December 23, 2013

Record last verified: 2015-10

Locations

US(1)