Thoracic Spine Manipulation for Individuals With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Manipulation; Sham Manipulation; Core Strengthening Exercises
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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; 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 intervention name(s): Thoracic Manipulation; Thoracic spine thrust manipulation; Lower thoracic manipulation; Middle thoracic manipulation; Sham thoracic manipulation; Transverse Abdominis exercises; Lumbar Multifidi exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracic manipulation; Low back pain; Core strengthening; Thoracic spine thrust manipulation