Thoracic Spine Manipulation for Individuals With Low Back Pain

Study Overview
=================
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: 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). 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. 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. 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.

Official Title
-----------------
Short-term Effects of Thoracic Spine Thrust Manipulation for Individuals With Low Back Pain: A Randomized Control Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Manipulation
* Other: Sham Manipulation
* Other: Core Strengthening Exercises


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>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<br>* 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<br>* Other names: Sham thoracic manipulation;Other: Core Strengthening Exercises<br>* 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.<br>* Other names: Lumbar Multifidi exercises;|
| Experimental: Manipulation<br>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<br>* 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.<br>* Other names: Middle thoracic manipulation;Other: Core Strengthening Exercises<br>* 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.<br>* Other names: Lumbar Multifidi exercises;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ) | 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. | Administered at the initial and final sessions (no more than 2 weeks apart) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Numeric Pain Rating Scale (NPRS) | 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. | Administered at the initial and final sessions (no more than 2 weeks apart) | 
| Change from Baseline on Numeric Pain Rating Scale (NPRS) | 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. | Administered at the initial session and 3 months after the final session | 
| Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ) | 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). | Administered at the initial and final sessions (no more than 2 weeks apart) | 
| Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ) | 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). | Administered at the initial session and 3 months after the final session | 
| Global Rating of Change Scale (GROC) | 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). | Administered at the final session (no more than 2 weeks after the initial evaluation) | 
| Change on the Global Rating of Change Scale (GROC) | 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). | Administered at the final session (no more than 2 weeks after the initial evaluation) and 3 months after the final session | 
| Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ) | 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. | Administered at the initial session and 3 months after the final session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic manipulation, Low back pain, Core strengthening, Thoracic spine thrust manipulation