Back2Sleep® Clinical Trial

Approved by the International Review Board (IRB)

    HIGHLIGHTS:

      • Users with chronic back pain used the product for 3 weeks
      • 78% experienced significant improvement
      • On average, significantly increased functionality was measured

        ABSTRACT: 36 participants identified as having chronic low back pain for more than 2 months were assessed over a 6-week period in an Institutional Review Board (IRB) approved clinical trial testing the efficacy of the Back2Sleep® back brace. The trial looked at both pain reduction and sleep quality.  The first three weeks of the trial served as the control in which a baseline sleep and pain score were determined. The second three weeks of the trial served as the experiment group, wherein the participants were given the Back2Sleep® brace to wear every night. The trial was funded by Pepper Medical, Inc.

        TRIAL DATES: April 2016-July 2016

        TRIAL DETAILS:

          • Trial Size: 36 participants
          • Duration: 6 weeks
          • Devices: Fitbit Charge HR®; Back2Sleep® brace
          • Metrics: Fitbit Charge HR® data, Wong-Baker FACES® Pain Rating Scale, the Pittsburgh Sleep Quality Index.
          • Abstract: Participants identified as having chronic back pain for more than 2 months were assessed over a 6 week period. The first half of the trial served as a baseline. For the second half of the trial, participants wore the Back2Sleep™ brace.
          • Outline: The first 3 weeks of the trial, participants wore the Fitbit Charge HR® 24 hours a day (without the brace) in order to obtain a baseline sleep quality level and activity level.  For weeks 4-6, participants wore both the Fitbit and Back2Sleep® brace; the Fitbit was worn 24 hours a day and the Back2Sleep® brace was worn only during sleep. Data from the Fitbit was analyzed by our team daily. Independently of the Fitbit metrics, the participants were asked to self-record their pain every morning for all 6 weeks, using the Wong-Baker FACES® Pain Rating Scale. Lastly, participants completed the Pittsburgh Sleep Quality Index questionnaire before and after the Back2Sleep® portion of the trial.
          • Followup: A 10 week followup interview with participants will be conducted. 

                ELIGIBILITY (INCLUSION) CRITERIA:           

                1. Age 25-65.
                2. Non-Smoker.
                3. Must currently experience chronic low back pain. 
                4. For the purposes of this trial, chronic low back pain will be classified as daily back pain experienced for at least 2 months.
                5. At its worst, the participant's pain level must be at least a 7 (on a scale of 1-10, with 10 being the worst).
                6. Low back pain must interfere with participant's sleep on a regular basis (Regular basis is defined as a minimum of 3 nights/week).
                7. Treatment: 

                  Participant(s) must not have received spinal surgery within the last 12 months.
                8. Participant(s) must not be scheduled to receive any surgery during the course of the trial.
                9. Previous steroid/cortisone injections are permitted. However, during the course of the trial participants should not receive any injections.
                10. During the trial, participants should not receive outside treatments for their back pain including, but not limited to: injections, physical therapy, massages, and electric stimulation.
                11. Medical Conditions: 

                  Participant(s) must not have sleep apnea or be diagnosed with any other sleep disorder(s).
                12. Participant(s) must not have co-morbidities (e.g. cancer, HIV)
                13. Approved conditions:

                  Spondylosis/Spondylolithesis (Pars defect), Degenerative disc disease, Scoliosis, Bulged or herniated disc(s) or history of herniated disc(s), Arthritic low back pain, Idiopathic back pain. 

                  RESULTS:

                  Three metrics were used to asses pain reduction and sleep quality:  The Wong-Baker FACES® Pain Rating Scale, the Pittsburgh Sleep Quality Index, and data from the Fitbit Charge HR®. Below is a summary of the results from each assessment measure.

                  The Wong-Baker FACES® Pain Rating Scale:

                  The Wong-Baker scale, pictured above, is a self-assessment tool in which participants rate their pain on a 6-point scale from 0 to 5.  Our study revealed that 48% of participants experienced a statistically significant reduction in pain, noting at least a .58 reduction in pain over a 3-week period, and 71% of participants noted some degree of improvement. 

                  The Pittsburgh Sleep Quality Index (PSQI): 

                  The PSQI, is an online survey that was completed by participants at the start and end of the trial. The three categories in which we saw improvement were the total sleep quality score, perceived sleep quality, and dysfunction - how their sleep quality impacts their daily behavior (e.g. being tired throughout the day, inability to focus, etc.)

                  • Total Sleep Quality Questionnaire Score: This measure includes 7 different dimensions of sleep. The higher the score, the poorer the sleep quality. With our study, we saw an average of 2 point improvement in sleep quality score. The maximum score that one can get on the questionnaire is 21, corresponding to a 16.7% improvement in sleep quality with a p-value of 0.05, yielding statistically significant results.  39% of participants saw an improvement of 2 points or greater, while approximately 70% of participants reported some degree of improvement.
                  • Perceived Sleep Quality or Self-Reported Sleep Quality This is scored with a single question that allows participants to rate their sleep as very good, fairly good, fairly bad, and very bad. This is also scored on a 3-point scale, in which a higher number is indicative of bad sleep. The average at baseline was 2.17 and the average at follow up was 1.17. This finding was highly statistically significant as our p-value was .000. This full point difference corresponds to a 33% improvement in perceived sleep quality. Furthermore, because the scale runs on whole number scoring, we can see the number of participants who experience this improvement. When doing this analysis, we found that 78% of the participants experienced a significant improvement in perceived sleep quality after wearing the brace.
                  • Dysfunction: The average dysfunction score at baseline was 1.52 and the average upon follow up was 1.04, or a .48 difference. When looking at the change on the 3-point scale, this corresponds to about a 32.4% improvement, indicating that participants’ ability to function throughout the day improved after wearing the brace.  These results had a p-value of 0.024 yielding statistically significant results.

                  Fitbit Charge HR®: 

                  While wearing a FitBit proved to be an enjoyable experience by our participants who were able to track their steps and sleep metrics, we were unable to detect any statistically significant trends when analyzing restless sleep and daily caloric expenditure on a population aggregate level with the T-Test or ANOVA. Confounding factors such as participant compliance in properly using the FitBit and variable device sensitivity lead to an overall statistical inaccuracy. 

                  What do participants have to say?  Great things! For quotes from our trial participants, please navigate to Testimonials