The effect of LymphaTouch® vs. a sham treatment on immediate pain and range of motion in acute low back pain

Greenstein, J., Etnoyer-Slaski, J., Huffman, A. & Behm. D. 2019. The 21st Annual Performance Health Scientific Advisory Committee (TRAC) Research Meeting

Background: Low back pain is the number one global burden, affecting 80% of people in the US at some point in their life. The LymphaTouch® is a medical treatment device which uses the effects of negative pressure in tissues for pain and swelling. It has been shown to improve pain 63.9%, with an average 3.5 decrease in pain scores in back and hip patients.

Purpose: The purpose of this study is to determine the effect of LymphaTouch® versus a sham treatment on pain and range of motion in individuals with acute low back pain

Design: Single-blind randomized clinical trial

Methods: A convenience sample of forty acute low back pain patients were recruited from an outpatient chiropractic clinic at their initial appointment. Participants were 18 years or older and diagnosed with acute low back pain. Exclusionary criteria \ included less than 18 years of age, pregnancy, cancer, a corticosteroid injection within the past 2 weeks, previous back surgery, acute deep vein thrombosis, acute infection, congestive heart failure, cardiac edema, kidney dysfunction, and any conditions in which increased venous and lymphatic return is undesirable. Eligible patients who agreed to participate in the study completed the informed consent, demographics information questionnaire (including pain medication usage), rated their overall pain on the Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI), and the Functional Rating Index (FRI) [T0]. Following the doctor’s evaluation, range of motion (ROM) was assessed using a digital goniometer and pain rated during each motion. Participants were then randomized into either the LymphaTouch® group [A] (n=30) or sham treatment group [B] (n=30). The participants were blind to which group they were assigned. Following the group selection, each participant received their assigned intervention. After the respective intervention, both groups immediately rated their overall pain and repeated the ROM tests [T1]. Then, all participants completed a satisfaction questionnaire about the intervention they received.

Statistical Analysis: Statistical analyses were completed using the SPSS software (Version 26.0, SPSS, Inc. Chicago, IL). First, Mauchly’s test of sphericity was conducted for all dependent variables. If the assumption of sphericity was violated, the Greenhouse- Geisser correction was employed. A mixed model repeated measures 2-way ANOVA (2 groups x 2 times) was used to analyze the data. Paired t-tests with Holm–Bonferroni corrections were used to decompose significant interactions, and Bonferroni post hoc tests were used if main effects were found. Significance was set at p ≤0.05. For significant maineffects and interactions, eta (proportion of variance associated with one or more main effects, or interactions) and observed power (statistical power of the test based on the effect size indicating the probability of finding a statistical difference) were calculated. Eta values represent; small (0.01), medium (0.06), and large (0.13) effects. Cohen’s d effect sizes (ES) were also calculated for significant specific interactions. Effect size (d) magnitude of change were calculated for interactions and reported as trivial (<0.2), small (0.2-0.49), medium (0.5- 0.79) or large (≥0.8) effect sizes (d) (Cohen 1988). Data is reported as mean ± SD.

Results/Conclusion: A total of 41 participants enrolled in the study with 38 having completed the study, 20 in the LymphaTouch® group (7M, 13F) and 18 in the sham treatment (11M, 7F). There was no significant between group effects (p=0.26) for pain, however there was a main effect for time (p<0.0001, eta: 0.34, Observed Power: 0.988) with a 10.04% (d=0.34) decrease from baseline (7.071.9) to post-treatment (6.362.15). A significant time x group interaction (p=0.001, eta: 0.27, Observed Power: 0.945) demonstrated a 18.5% (d=0.59) pain reduction with LymphaTouch® Group from baseline (7.02.03) to post-treatment (5.72.3). There was no significant (p=0.16) change over time for the Sham Group. For trunk flexion ROM, there was no significant between group effects