Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

This study has been completed.
Sponsor:
Collaborator:
Texas Physical Therapy Association
Information provided by (Responsible Party):
Kelli Brizzolara, Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01559948
First received: February 3, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Behavioral: Lumbopelvic stabilization exercise
Device: Sacroiliac joint belt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

Resource links provided by NLM:


Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • Change in Oswestry Low Back Pain Questionnaire [ Time Frame: week: 0, 4, 12 ] [ Designated as safety issue: No ]
    The Modified Oswestry Back Pain Questionnaire(OSW) will be used to determine Low back pain-related disability. The OSW consists of 10 items assessing different aspects of pain and function related to LBP. Each item is scored 0-5 with higher scores representing greater disability.


Secondary Outcome Measures:
  • Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: week: 0, 4, and 12 ] [ Designated as safety issue: No ]
    The numeric pain rating scale (NPRS) is an 11-point scale with 0 representing "no pain" and 10 representing "worst imaginable pain." This scale will be used to assess severity of pain.

  • Percent change of muscle thickness for the transverse abdominis (TrA) and internal oblique (IO) [ Time Frame: week: 0, 4, and 12 ] [ Designated as safety issue: No ]
    The percent change of muscle thickness of the TrA and IO will be assessed using ultrasound imaging. The deep abdominal muscles will be imaged in brightness mode (b-mode) using the SonoSite M-Turbo Ultrasound System. A 2-5 MHz broad spectrum curvilinear transducer will be used to obtain the images. The percent change of muscle thickness will be calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%

  • Change in Global rating of change (GROC) scale [ Time Frame: week: 4 and 12 ] [ Designated as safety issue: No ]
    The GROC scale will be used to assess the participants' overall perception of improvement since the beginning the interventions. This is a scale ranging from -7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better").


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbopelvic stabilization exc + belt
The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.
Device: Sacroiliac joint belt
Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. 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.
Active Comparator: Lumbopelvic stabilization exercise
The participants will be instructed in a lumbopelvic stabilization program.
Behavioral: Lumbopelvic stabilization exercise
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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral pain near the sacroiliac joint that does not extend pass the knee
  • positive result on 2 of 6 sacroiliac joint provocation tests:

    • compression test
    • distraction test
    • posterior shear test
    • Gaenslens' test (left and right)
    • sacral thrust test

Exclusion Criteria:

  • current pregnancy or pregnancy in the last 6 months
  • history of surgery to lumbar spine, pelvis, chest, abdomen
  • history of congenital lumbar or pelvic anomalies
  • any neurological signs in the lower extremity
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559948

Locations
United States, Texas
Texas Woman's University
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Texas Woman's University
Texas Physical Therapy Association
Investigators
Principal Investigator: Kelli J Brizzolara, MS Texas Woman's University
  More Information

No publications provided

Responsible Party: Kelli Brizzolara, Graduate student, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01559948     History of Changes
Other Study ID Numbers: 16931
Study First Received: February 3, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Woman's University:
Low back pain
Sacroiliac joint pain
Lumbopelvic stabilization program
Pelvic compression belt
Deep abdominal muscles

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Arthralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 16, 2014