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Thoracic Spine Manipulation for Individuals With Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853357
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Rocky Mountain University of Health Professions
Information provided by (Responsible Party):
Laura Fisher, University of Michigan

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date May 31, 2018
Actual Study Start Date  ICMJE October 31, 2016
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ) [ Time Frame: Administered at the initial and final sessions (no more than 2 weeks apart) ]
The MODQ is a functional scale assessing the impact of low back pain on daily activities by assigning a disability score according to the answered questions. The scale includes 10 questions regard the level of pain and interference with several physical activities including: sleeping, lifting, travelling, self-care, and social life. Each question has six possible responses (scored from 0 to 5), and patients are asked to pick the one that most accurately responds to their condition. The sum of the response is divided by the total possible score and multiplied by 100 to receive a percentage of disability with 0% corresponding to no disability and 100% corresponding to a great deal of disability.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Change from Baseline on Numeric Pain Rating Scale (NPRS) [ Time Frame: Administered at the initial and final sessions (no more than 2 weeks apart) ]
    An 11-point numeric pain rating scale will be used to assess pain before and after treatment. The scale ranges from 0 "no pain" to 10 "worst possible pain."
  • Change from Baseline on Numeric Pain Rating Scale (NPRS) [ Time Frame: Administered at the initial session and 3 months after the final session ]
    An 11-point numeric pain rating scale will be used to assess pain before and after treatment. The scale ranges from 0 "no pain" to 10 "worst possible pain."
  • Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ) [ Time Frame: Administered at the initial and final sessions (no more than 2 weeks apart) ]
    The FABQ is used to quantify individual's fear avoidance beliefs and LBP specifically regarding avoiding activity. The FABQ is divided into physical activity (FABQ-PA) and work subscales (FABQ-W) in which patients rate their agreement of each statement on a seven point Likert scale (0 is completely disagree and 6 is completely agree).
  • Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ) [ Time Frame: Administered at the initial session and 3 months after the final session ]
    The FABQ is used to quantify individual's fear avoidance beliefs and LBP specifically regarding avoiding activity. The FABQ is divided into physical activity (FABQ-PA) and work subscales (FABQ-W) in which patients rate their agreement of each statement on a seven point Likert scale (0 is completely disagree and 6 is completely agree).
  • Global Rating of Change Scale (GROC) [ Time Frame: Administered at the final session (no more than 2 weeks after the initial evaluation) ]
    The GROC is used to assess self-perceived improvement of the intervention. The GROC is a 15-point scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better).
  • Change on the Global Rating of Change Scale (GROC) [ Time Frame: Administered at the final session (no more than 2 weeks after the initial evaluation) and 3 months after the final session ]
    The GROC is used to assess self-perceived improvement of the intervention. The GROC is a 15-point scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better).
  • Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ) [ Time Frame: Administered at the initial session and 3 months after the final session ]
    The MODQ is a functional scale assessing the impact of low back pain on daily activities by assigning a disability score according to the answered questions. The scale includes 10 questions regard the level of pain and interference with several physical activities including: sleeping, lifting, travelling, self-care, and social life. Each question has six possible responses (scored from 0 to 5), and patients are asked to pick the one that most accurately responds to their condition. The sum of the response is divided by the total possible score and multiplied by 100 to receive a percentage of disability with 0% corresponding to no disability and 100% corresponding to a great deal of disability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracic Spine Manipulation for Individuals With Low Back Pain
Official Title  ICMJE Short-term Effects of Thoracic Spine Thrust Manipulation for Individuals With Low Back Pain: A Randomized Control Trial
Brief Summary The purpose of this study is to determine the short-term effects of thoracic spine thrust manipulation on participants with low back pain. Participants in this study will be randomized to receive either the lower thoracic spinal manipulation and a standard set of exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized that thoracic manipulation when combined with core strengthening exercises will have positive short term improvements in pain and function for patients with LBP as compared to a sham manipulation combined with core strengthening exercises.
Detailed Description

This study aims to use a randomized controlled trial design to investigate the effects of thoracic spinal manipulation in conjunction with core strengthening exercises when compared to a sham manipulation and core strengthening exercises on patients with low back pain. Core strengthening exercises have been shown to improve pain and functional status in patients with non-specific low back pain when compared to conventional exercise. However, there is strong evidence to suggest that exercise alone is not adequate for the management of low back pain. Spinal manipulation has demonstrated promising results for the management of low back pain, but it is unclear whether the targeted location of manipulation is important. It is hypothesized that thoracic manipulation when combined with core strengthening exercises will have positive short term improvements in pain and function for patients with LBP as compared to a sham manipulation combined with core strengthening exercises based on the theory of regional interdependence. The specific aims of the study are as follows:

  1. To determine the effects of thoracic spine manipulation and core strengthening exercise on function in individuals with low back pain, specifically measured by changes in Modified Oswestry Low Back Pain Disability Questionnaire (MODQ).
  2. To determine the participant's perception of improvement following thoracic spine manipulation and core exercises, measured by global rating of change (GROC), when compared to a sham manipulation.
  3. To determine the effects of thoracic spine manipulation and core exercises on fear avoidance, measured by fear-avoidance belief questionnaire (FABQ), on individuals with low back pain.
  4. To determine the effects of thoracic spine manipulation and core exercises on pain using numeric pain rating scale (NPRS).

The ability to demonstrate the effectiveness of a manipulation targeted at the thoracic spine in conjunction with core exercises could provide clinicians a simple, effective treatment strategy for low back pain that not only has minimal injury risk, but has the potential to improve pain and function, ultimately decreasing the healthcare costs associated with low back pain.

The effects of treatment on disability, fear-avoidance, and pain will be analyzed using a 2x2 repeated measures multivariate analysis of variance (MANCOVA), with pre/post-test measures and time as the two factors and duration of symptoms serving as a covariate. An independent t test will be used to determine differences for the Global Rating of Change between groups at follow up, and the number needed to treat (NNT) will be calculated. Spinal manipulation has some potentially serious risks including, fracture, numbness, tingling, or injury to the spinal cord. However, these risks are very low in the thoracic spine where manipulation is targeted during this study. In a recent systematic review which evaluated the safety of thoracic spine manipulation, the authors found only seven cases of serious trauma which have resulted from thoracic spine manipulation. The majority of these cases were performed by a chiropractor and it is unsure whether participants had contraindications to manipulation. In order to mitigate these risks, participants will be thoroughly screened for contraindications to spinal manipulation. If an adverse event does occur, the participant will be referred to the appropriate provider and their participation in the study will be discontinued.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Other: Manipulation
    Middle Thoracic: Participants are placed in the supine position with their arms over their chest. The clinician rolls the participant to their side and places the fulcrum at the desired thoracic segment and the participant is rolled back onto the clinician's hand. The participant is instructed to take a deep breath. As the participant is exhaling, the clinician uses his body to push through the participant's arms to perform a high velocity thrust in an anterior to posterior directed force. Lower Thoracic: With the patient in a prone position, the clinician achieves a "skin lock" with both pisiforms over the transverse processes of the target vertebra. The clinician then uses his body to push down through his arms to perform a high-velocity, low-amplitude posterior to anterior thrust.
    Other Names:
    • Thoracic Manipulation
    • Thoracic spine thrust manipulation
    • Lower thoracic manipulation
    • Middle thoracic manipulation
  • Other: Sham Manipulation
    The participants are positioned in prone and the clinician's hands are placed with the pisiforms of each hand over the transverse processes of the target vertebra. The clinician will only apply minimal pressure and slide the hands across the skin to mimic the manipulative thrust. This sham procedure has been shown to be an adequate sham comparator for spinal manipulative therapy (SMT) with similar expectations and believability as SMT active treatment
    Other Name: Sham thoracic manipulation
  • Other: Core Strengthening Exercises
    Both groups will receive the following exercises at each visit. The core strengthening (core strengthening) exercises are a standard protocol used by Richardson et al and Franca et al which are proposed to target muscles responsible for segmental stabilization, specifically the transverse abdominis (TrA) and the lumbar multifidi (LM). Exercises will include: TrA exercises in 4 point kneeling and in supine with flexed knee, LM exercises in prone, and co-contraction of TrA and LM in upright position. Three sets of 15 repetitions will be done for each exercise.
    Other Names:
    • Transverse Abdominis exercises
    • Lumbar Multifidi exercises
Study Arms  ICMJE
  • Sham Comparator: Control
    The control group includes randomized participants that will receive a sham manipulation. Participants will also complete the standard set of core strengthening exercises.
    Interventions:
    • Other: Sham Manipulation
    • Other: Core Strengthening Exercises
  • Experimental: Manipulation
    The manipulation group includes randomized participants that will receive a thoracic spine thrust manipulation. Participants will also complete the standard set of core strengthening exercises.
    Interventions:
    • Other: Manipulation
    • Other: Core Strengthening Exercises
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018)
101
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
108
Actual Study Completion Date  ICMJE May 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

The precise inclusion criteria scores are not indicated in the inclusion criteria below to avoid inappropriate self-selection of participants. After enrollment and data collection are complete, the investigators will list the actual minimum scores allowable for inclusion, when the data can no longer be skewed.

Inclusion Criteria:

  • A certain minimum pain intensity score on an 11-point numeric pain rating scale (ranging from 0-10 points)
  • A certain minimum disability rain on the Modified Oswestry Disability Questionnaire
  • Individuals who have received a prescription for physical therapy for low back pain

Exclusion Criteria:

  • Contraindications to spinal manipulation such as osteoporosis, active cancer, previous spinal surgery, spinal fracture, acute rheumatic disease, active tuberculosis, pregnancy, active infections of the vertebra or intervertebral disc, any neurological evidence suggesting compromise of the nerve roots or spinal cord (changes in myotomal strength, deep tendon reflexes, or sensation), or cauda equina syndrome
  • Insufficient English skills to complete questionnaires
  • Are involved in litigation or a workman's compensation claim
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853357
Other Study ID Numbers  ICMJE HUM00105566
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Fisher, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Rocky Mountain University of Health Professions
Investigators  ICMJE
Principal Investigator: Laura Fisher, BS, DPT, OCS University of Michigan
PRS Account University of Michigan
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP