Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
Condition: Low Back Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Purpose: The primary purpose of this study is to determine whether or not the addition of
      thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach
      consisting of motor control exercises and lumbar spine manual therapy is better than standard
      PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity,
      disability level, and perceived change in patients with chronic low back pain (CLBP) and
      movement coordination impairments.

      Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving
      thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants
      receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity,
      physical disability level, and perceived change at two, four, and 12 weeks after initiating
      treatment.
    

Detailed description: 
      This study will use a 2x4 factorial mixed design with a between-factor independent variable
      (IV) of group and a within-factor IV of time. The dependent variables include hip ROM,
      segmental mobility of the thoracolumbar spine, pain, disability level, and patients'
      perceived rating of change (GROC). Hip ROM and spinal mobility variables will be measured by
      the researchers, while pain, disability level, and GROC score will be measured by
      self-reported questionnaires.

      The experimental group will receive a motor control exercise program and manual therapy to
      the hips and spine corresponding to the individual's unique mobility impairments. The
      comparison group will receive a motor control exercise program and manual therapy to the
      lumbar spine only. Both groups will receive treatments at an outpatient clinic 2 times a week
      for 4 weeks. All outcome measures will be collected at baseline (except the GROC), and then
      at two weeks, four weeks, and twelve weeks after beginning treatment.

      All study participants will receive a motor control exercise program consistent with standard
      of care. Exercises will be targeted to the abdominals, hip flexors, back extensors, hip
      extensors, hip flexors, hip abductors, and hip adductors, but will begin with those muscles
      that test weakest in the clinical exam. Generally, exercises for each subject begin with
      isolated isometric contractions to ensure adequate motor control, and progress through
      various degrees of agonist loading with co-contraction of synergists using isotonic open or
      closed chain movements. Instructions to gradually increase time under tension to a maximum of
      30 seconds for four repetitions will be used in order to provide an element of
      graded-activity exposure and to reflect the tonic nature of stabilizing muscles. Participants
      unable to complete all exercises by the end of the fourth week will be instructed on how to
      progress to the final exercises with their independent home exercise program.

      In addition to a motor control exercise program, all participants will receive manual therapy
      to the lumbar spine. Standard PT manual therapy will be limited to non-thrust passive
      accessory (PA) mobilizations from L1-L5 or soft tissue mobilization to the lumbar paraspinals
      or quadratus lumborum. Only the participants in the experimental group will receive manual
      therapy to the hips and thoracic spine according to the mobility impairments identified
      during the initial testing session. The manual therapy interventions utilized at the hips and
      thoracic spine are considered standard of care for treatment of those regions, but could be
      considered experimental for treatment of low back pain. Regional manual therapy will include
      a variety of thrust and non-thrust techniques targeting the thoracic, lumbopelvic, or hip
      joints. Hip-based techniques including anterior-posterior hip mobilization, caudal thrust or
      non-thrust mobilization, and posterior-to-anterior mobilization will be performed. The choice
      of initiating or suspending a specific manual therapy technique and the grade of treatment
      will be left to the discretion of the treating therapist (other than the PI). Prior to the
      commencement of the study, all treating physical therapists will be trained in administration
      of standard motor control exercises and manual therapy.
    

Intervention name(s): Regional manual therapy; Standard physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy.; The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment