Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Low Back Pain
Condition: Low Back Pain; Chronic Low Back Pain; Subacute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The investigators would like to know which one of two exercise programs will have a greater
      effect on balance, functional performance, daily function, and pain on individuals with low
      back pain (LBP) after 2, 4 and 8 weeks.

      Specifically, the differences in dynamic balance, functional performance, pain intensity, and
      disability level will be compared between participants who receive spinal stabilization
      exercises program (SSE) and those who receive a general exercise program (GE) which includes
      range-of-motion (ROM) and flexibility exercises.

      The research hypotheses are:

        1. The SSE program will significantly improve dynamic balance and functional performance in
           adult participants with sub-acute and chronic LBP at two and four weeks as well as after
           an eight-week follow-up after initiating intervention.

        2. The SSE program will significantly improve pain intensity and disability level in adult
           participants with sub-acute and chronic LBP at two and four weeks as well as after an
           eight-week follow-up after initiating intervention.

        3. In adult participants with sub-acute and chronic LBP, the group receiving the SSE
           program will demonstrate significantly improved dynamic balance, functional performance,
           pain intensity and disability levels compared to the placebo group receiving the GE
           program at two and four weeks as well as after an eight-week follow-up after initiating
           intervention.
    

Detailed description: 
      Participants will be required to wear a pair of shorts, a loose T-shirt, and a pair of tennis
      shoes for this study. On the first visit, the investigators will do some tests to make sure
      that potential participant has good feeling and strength in his/her legs. Next, each
      participant will fill out a few forms asking about daily function and back pain. Then, the
      investigators will ask the participant to perform a balance test and seven functional tests.
      Two investigators will be there to give these tests.

      During the balance test, each participant will stand on one leg and reach out for a distance
      with the other leg. During the functional tests, the participant will perform 7 different
      tasks, including a deep squat, hurdle step, in-line lunge, shoulder mobility, active straight
      leg raise, rotary stability and trunk stability push-up. The investigators will demonstrate
      these tests before the participant perform them.

      After the balance and functional tests, each participant will be randomly assigned to one of
      the exercise programs. One of the investigators will instruct each participant to do the
      appropriate exercises depending on his/her ability and pain level.

      After the first visit, participants will be asked to come back 1-2 times per week for 4 weeks
      so the investigators can update participants' exercise program and make sure that
      participants do each exercise in the correct form. Each follow-up visit will take about 30
      minutes. In addition to the physical therapy visits, the investigators will ask participants
      to do the most updated exercises at home once a day and at least 5 times a week. The
      investigators will give each participant an exercise log to track the frequency of the home
      exercise sessions. At the end of the 4 weeks, participants will come to the last physical
      therapy session and will be asked to continue to do the updated exercises at home once a day
      and at least 5 times a week for another 4 weeks until the 8-week follow-up visit.

      At the 2-week, 4-week and 8-week follow-up visit, the investigators will repeat the balance
      and the 7 functional tests.

      Each testing session will last about 30 minutes. The testing sessions at 2 and 4 weeks will
      be done on the same visit of physical therapy for the participants' exercise sessions. During
      the 8-week follow-up visit, the investigators will ask the participants to fill out the forms
      about their daily function and back pain in addition to the balance and 7 functional tests.
      At the end of the 8 weeks, if the participants wish to have the other exercises, the
      investigators will instruct them with those exercises.
    

Intervention name(s): Exercises
Intervention type(s): Other
Intervention description(s): Participants in the treatment group will be instructed in the spinal stabilization exercises (SSEs), modeled after the spinal stabilization exercise program designed by Hicks et al. (2005). The SSE program targets muscle activation of spinal stabilizers specifically, the transversus abdominus and lumbar multifidus muscles. Each exercise will be progressed by increasing repetitions and hold time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a randomized clinical trial (RCT) using a prospective two-way (2 × 4) mixed-design to examine the effectiveness of spinal stabilization exercises (SSEs) on dynamic balance, functional performance, pain intensity, and disability level in adults with sub-acute and chronic low back pain (LBP).
The two independent variables are group, which is a between-subject factor, and time which is a within-subject factor. The independent variable of group has two levels: (1) the treatment group which will receive SSEs, and (2) the placebo group which will receive general range of motion and flexibility exercises.
The independent variable of time has four levels: pre-intervention at baseline, and two weeks, four weeks, and eight weeks after intervention.
The four dependent variables are (1) dynamic balance, (2) functional performance, (3) pain intensity, and (4) disability level.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Y-balance test; Functional Movement Screen; Spinal stabilization exercises; Dynamic balance; Postural control; Physical performance