Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Condition: Low Back Pain
MeSH terms: Arthralgia; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial is to examine the usefulness of the addition of
      a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac
      joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to
      lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry
      Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness
      (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric
      Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement
      using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores
      and NPRS scores will be lower for those who receive the compression belt in addition to the
      lumbopelvic stabilization program as compared to those who receive the lumbopelvic
      stabilization alone. The percent change of muscle thickness for the deep abdominals as well
      as the GROC scores will be higher for those who receive the compression belt in addition to
      the lumbopelvic stabilization program as compared to those who receive the lumbopelvic
      stabilization alone.
    

Detailed description: 
      Background: The estimated prevalence of sacroiliac joint (SIJ) pain is approximately 13-30%
      in patients with non-specific low back pain. One common presentation for those with SIJ pain
      is unilateral pain over the SIJ region, which is described as a positive Fortin's sign.
      Common impairments for this population include pelvic asymmetry, lumbopelvic muscle
      imbalance, and decreased lumbopelvic proprioceptive awareness and stability. Two common
      physical therapy interventions for this population are lumbopelvic stabilization programs and
      pelvic compression belts. The purpose of this randomized clinical trial is to examine the
      usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization
      program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization
      exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone.
      Participants: Thirty participants with unilateral pain near the SIJ will be recruited for the
      study and randomly assigned to 1 of 2 treatment groups (stabilization plus belt or
      stabilization alone). Both groups will receive a lumbopelvic stabilization program for 12
      weeks. The stabilization plus belt group will also receive a pelvic compression belt to be
      worn continuously for the first 4 weeks. Outcome measures including the Modified Oswestry Low
      Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e.
      muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain
      Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using
      the Global Rating of Change (GROC) scale will be collected. These outcomes will be assessed
      at baseline, 4 weeks, and 3 months post-intervention. Hypothesis: The OSW scores and NPRS
      scores will be lower for those who receive the compression belt in addition to the
      lumbopelvic stabilization program as compared to those who receive the lumbopelvic
      stabilization alone. The percent change of muscle thickness for the deep abdominals as well
      as the GROC scores will be higher for those who receive the compression belt in addition to
      the lumbopelvic stabilization program as compared to those who receive the lumbopelvic
      stabilization alone. Data Analysis: Two separate ANOVAs (group x time) with repeated measures
      will be used to examine the effect of the interventions on disability and the percent change
      of muscle thickness. Whitney U-test will be used to analyze the NPRS data, and descriptive
      statistics will be used to report the GROC scores. Clinical Relevance: The results of the
      study may provide evidence in prescribing pelvic compression belt for those with SIJ pain. It
      will also offer guidance as to how and when pelvic compression belts should be used in this
      population. Finally, it will guide physical therapists in prescribing effective interventions
      for those with SIJ pain.
    

Intervention name(s): Lumbopelvic stabilization exercise; Sacroiliac joint belt
Intervention type(s): Behavioral; Device
Intervention description(s): The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will complete 4 different exercises daily: one in supine, one in standing, one in quadruped, and one in a side-bridge position. The dosage for each exercise is 20 reps with an 8 second hold. In supine, the first exercise is the abdominal drawing-in maneuver. In standing, the first exercise is the abdominal drawing-in maneuver. In quadruped, the first exercise is alternating arm lifts. The final exercise is the side-bridge hold. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria.; The belt should be worn low around the pelvis just above the greater trochanter and instructed to wear the belt during all waking hours of the first four weeks of the study. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Sacroiliac joint pain; Lumbopelvic stabilization program; Pelvic compression belt; Deep abdominal muscles