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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

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Manipulation Other: Sham Manipulation Other: Core Strengthening Exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effects of Thoracic Spine Thrust Manipulation for Individuals With Low Back Pain: A Randomized Control Trial
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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."

  2. 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."

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853357


Sponsors and Collaborators
University of Michigan
Rocky Mountain University of Health Professions
Investigators
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Principal Investigator: Laura Fisher, BS, DPT, OCS University of Michigan
Publications of Results:
Other Publications:
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Responsible Party: Laura Fisher, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02853357    
Other Study ID Numbers: HUM00105566
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Fisher, University of Michigan:
Thoracic manipulation
Low back pain
Core strengthening
Thoracic spine thrust manipulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms