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History of Changes for Study: NCT01168999
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Latest version (submitted October 5, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 22, 2010 None (earliest Version on record)
2 March 7, 2011 Study Status
3 September 16, 2011 Sponsor/Collaborators and Study Status
4 March 22, 2012 Study Status and Outcome Measures
5 September 26, 2012 Study Status, Arms and Interventions and Study Design
6 November 4, 2013 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Study Design, Results and Arms and Interventions
7 January 7, 2014 Outcome Measures, Baseline Characteristics and Study Status
8 October 5, 2015 Arms and Interventions and Study Status
Comparison Format:

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Study NCT01168999
Submitted Date:  July 22, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 345-2009
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2010
Overall Status: Recruiting
Study Start: September 2009
Primary Completion: September 2011 [Anticipated]
Study Completion: September 2011 [Anticipated]
First Submitted: July 22, 2010
First Submitted that
Met QC Criteria:
July 22, 2010
First Posted: July 23, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 22, 2010
Last Update Posted: July 23, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Florida
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Low Back Pain
Keywords: low back pain
spinal manipulation
manual therapy
placebo
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 88 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: spinal manipulation
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
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
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
natural history
Participants in this arm of the study receive no treatment
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. expectation for treatment effectiveness
[ Time Frame: 2 weeks ]

how helpful participants expect the assigned intervention will be in decreasing their low back pain
3. 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
4. disability
[ Time Frame: 2 weeks ]

oswestry functional questionnaire to measure functional limitations related to low back pain
5. pain sensitivity
[ Time Frame: 2 weeks ]

self report of pain resulting from standardized thermal and pressure pain stimuli
Secondary Outcome Measures:
1. low back range of motion and strength
[ Time Frame: 2 week ]

measures of low back range of motion and abdominal strength
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Joel E Bialosky, PhD
Telephone: 352-273-8636
Email: bialosky@phhp.ufl.edu
Locations: United States, Florida
University of Florida
[Recruiting]
Gainesville, Florida, United States, 32610
Contact:Contact: Joel E Bialosky, PhD 352-273-8636 bialosky@phhp.ufl.edu
Contact:Principal Investigator: Joel E Bialosky, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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