The Effects of Self-Natural Posture Exercise Programs on Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a major health problem across the United States, with socio-economic burden,
      major cause of disability, and poor quality of life. One such non-pharmacologic treatment is
      Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction
      with orthodontic bracing principles. Belts are worn around the hips (pelvic correction belt)
      and legs (right posture belt) to assist with self-directed exercise and posture correction. A
      typical SNPE program has eight different movements, targeting the entire axial skeleton. The
      exercises can be practiced anywhere and are widely applicable to patients as exercises are
      low- to moderate-intensity flexibility-based muscle strength training. There are several
      studies from Korea examining the efficacy of SNPE; however, there are few English language
      studies and there are no studies from outside the country of South Korea. As such, there is
      little data the generalizability of SNPE, the degree of cultural acceptance in other
      countries, and the all-important adherence to the home exercise program. The present study
      proposes to be the first study outside of South Korea to examine the effects of SNPE on
      chronic low back patients.
    

Detailed description: 
      The present study seeks to repeat the previously described positive clinical impact of SNPE
      in a new population, examine rates of adherence, and compare the effects of face-to-face
      versus online courses.

      Specific Aims:

        1. Aim 1: Investigate the adherence to an SNPE program in American adults to explore the
           generalizability of existing Korean data.

        2. Aim 2: Assess the effects of a 12-week face-to-face vs online SNPE program on back pain.
           We hypothesize that the face-to-face group will show greater pain reduction and
           improvements in body posture and quality of life compared to the control group after
           phase 1.

        3. Aim 3: Compare adherence to and effects of face-to-face vs online 12-week SNPE programs.

        4. Aim 4: Investigate the adherence to and effects of face-to-face vs online 12-week SNPE
           programs at a follow-up of 12 weeks.

      A single-blind randomized controlled trial (RCT) design with a wait-list control group will
      be used to evaluate the effect of SNPE for back pain reduction. The control group will
      receive online SNPE intervention after serving as an untreated comparison group. The
      wait-list control group serves two purposes. First, it provides an untreated comparison for
      the face-to-face group to determine if the intervention had an effect. By serving as a
      comparison group, researchers are able to isolate the independent variable and look at the
      impact it had. Second, it allows the wait-listed participants an opportunity to obtain the
      intervention at a later date.

      Recruitment:

      Flyers, Billings Clinic employee emails, and social media will be used to recruit
      participants. Recruitment messages will include relevant information about the study,
      benefits, and inclusion criteria as well as a link to a study-specific website recapitulating
      this information (https://xppizim.wixsite.com/snpestudy). When patients contact the
      investigators, any questions will be answered. If the patient chooses to go forward, the ODI
      Questionnaire and Self-reported Data Form will be collected online (www.surveymonkey.com).
      Data will be reviewed for eligibility, and if appropriate, participant will be sent the
      information contained on the consent form to review; the actual signed form will be collected
      at time of their 1st assessment prior to the collection of data.

      After being assessed by a physiatrist, eligible participants will be invited to participate
      in the study. All participants will have an equal chance of being randomly assigned (using a
      random number table from Microsoft Excel to produce random numbers).

      Analyses:

      All data will be exported from www.surveymonkey.com and analyzed using the Statistical
      Package for Social Sciences (SPSS) application. Descriptive statistics will be used to
      summarize demographic variables. To investigate adherence mentioned in Aim 1 and 4,
      frequencies and percentages will be analyzed for categorical variables and mean, standard
      deviation, quartiles, and ranges for continuous variables. For Aim 2 and 3, all outcome
      measures will be compared between groups (Assessment 1 will be considered the baseline for
      face-to-face (FTF) and Assessment 2 will be the baseline for online (ONL)), will be analyzed
      using an analysis of covariance (ANCOVA) via the General Linear Model (GLM). Age and gender
      will be controlled as covariates. If there is a significant difference using ANCOVA, we will
      follow up with post hoc testing.
    

Intervention name(s): Self-Natural Posture Exercise training
Intervention type(s): Behavioral
Intervention description(s): SNPE training will be provided face-to-face or online by certified instructors. The SNPE exercise training involves the use of special belts to align and stabilize posture and joints. Up to 4 belts can be used, placed around the hips, around the thighs, below the knees, and above the ankles. Myofascial release is part of the training, which is self-performed with SNPE equipment.
Other intervention name(s): SNPE training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blind randomized controlled trial (RCT) design with a wait-list control group
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: therapeutic; rehabilitation; stabilization; behavioral