35 Day

WavWatch Back Pain Phase II

STUDY TITLE	WavWatch Back Pain Phase II
Submitted under umbrella	Umbrella Protocol for Efforia Personalized Agentic Hypothesis Discovery & Experiential Proof Trials
Date submitted	—
End date	There is no pre-specified end date and sub-studies remain open long-term.
Language	English
Efforia AI IRB approval recommendation	—
Recruitment page preview	Preview
Informed consent	Review
Study author	Joseph Bamber, John Bamber, Linda Bamber
Principal investigator	Matthew Amsden
Sub-Investigator for Adverse Events	Dr. Viral Patel
Description	A 35-day single-arm Phase II study evaluating whether daily use of WAVwatch 2.0 is associated with meaningful improvements in recurring back pain, pain interference, and physical function. The study begins with a 7-day untreated run-in period, followed by 28 days of standardized WAVwatch use. Participants serve as their own controls, allowing comparison of a stable pretreatment baseline with the final treatment week while keeping the daily study experience brief.
Participant engagement length	35 Days
Sponsor	This study is made possible by your payment to cover all supplies and expenses required to participate.
Cost to participant	$597
Included products & services	WAVwatch 2.2 Preorder: $697
Outcome measures	ROMIS® Numeric Rating Scale v.1.0 – Pain Intensity 1a Pain Interference – Short Form 6b PROMIS Physical Function – Short Form 10a Survey
Methodology	Single Arm longitudinal where participants act as their own control
Basic or advanced dissemination plan	Basic
Deviation from recruitment approach	No
Deviation from statistical approach	No
Will study include “more about you questions”	No
ClinicalTrials.gov	Yes
Commitment to list findings on ClinicalTrials.gov	Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

WAVwatch 2.0 is a non-invasive wearable sound-frequency device. During the 28-day treatment period, participants use the Pain > Back Support frequency set once daily for the full standard programmed session, following normal manufacturer wear and volume guidance. The study does not instruct participants to loop or extend sessions beyond normal product guidance.

Included Products & Services

Product Name: WAVwatch 2.2 Preorder

Quantity included: 1

Price: $697.00

Product Description: WAVwatch 2.2 is here! Due to extremely high demand, our first batch of Rose Gold pre-orders are now sold out. New Rose Gold orders will not ship until January. Pay in full now to reserve yours in advance. Get more personalized wellness possibilities than ever before! ✓ 20 New Frequency Sets✓ Improved durability & water resistance ✓ Up to 18 hour battery life ✓ No WiFi, Bluetooth, or EMFs! WAVwatch 2.2 delivers a major upgrade from 2.0 — expanding from 146 to 166 Frequency Sets, adding brand-new programs for energy, detox, brain clarity, sleep, men’s and women’s health, and overall daily wellness. WAVwatch 2.2 includes the completely new Good Energy folder, enhanced WAVdetox options, a dedicated Vagus Nerve program, and redesigned Men’s and Women’s Health sets that replace the old “Reproductive Wellness” program with more targeted, effective support. All original 2.0 frequencies remain, but 2.2 organizes them more intuitively, adds 20 powerful new options, and features improved durability and water resistance. In short.

Product Image: WAVwatch 2.2 Preorder

Ingredients:

Product Safety: rose gold

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Inclusion

Age 18 or older.
Recurring back pain or discomfort on multiple days per week.
Willing to complete a 7-day untreated baseline before beginning the WAVwatch Back Support frequency.
Willing to use WAVwatch daily for 28 days and complete brief study assessments.
Willing to keep other back-pain treatments and routines reasonably stable when medically appropriate.

Do not participate or seek medical guidance first if:

You have severe, rapidly worsening, unexplained, or emergency-level back pain.
You have a recent major back surgery or acute back injury.
You have symptoms that warrant medical evaluation rather than a wellness study.
You anticipate beginning or substantially changing another back-pain treatment during the study in a way that would make the results difficult to interpret.
You have previously been advised by a clinician not to use wearable sound/vibration devices.

Study Design & Experience

Single-arm, within-person 35-day study with a 7-day untreated run-in followed by 28 days of WAVwatch treatment. Participants complete one brief pain rating daily throughout the study. Treatment adherence is tracked separately through a quiet daily use-confirmation task. PROMIS Pain Interference and Physical Function are measured at the end of baseline and at fixed treatment Days 7, 14, 21, and 28. Safety is assessed weekly. The primary analysis compares average daily pain during baseline with average pain during treatment Days 22-28.

Statistical Analysis Plan

Primary analysis: for participants with sufficient daily data, calculate each participant's mean daily back-pain score during the 7-day untreated baseline and mean score during treatment Days 22-28. Analyze the paired within-person change with descriptive statistics, 95% confidence intervals, and an appropriate paired inferential test; report standardized within-person effect size and responder proportions using a prespecified clinically meaningful improvement threshold where justified. Secondary analyses: baseline-to-Day-28 changes in PROMIS Pain Interference and Physical Function, plus trajectories across treatment Days 7, 14, 21, and 28 using repeated-measures methods or mixed-effects models when sample size supports them. Explore adherence-response associations using daily WAVwatch-use confirmations. Expectations may be evaluated as a covariate or moderator. Report missingness and conduct sensitivity analyses requiring prespecified minimum daily completion during baseline and final treatment week. Analyses will distinguish intended time points because each weekly outcome is configured as a separate task.

Limitations & Justification

This remains a single-arm study and cannot fully separate treatment effects from expectancy, regression to the mean, natural history, or concurrent behaviors. The untreated run-in, repeated daily primary outcome, expectation assessment, standardized treatment instructions, and stable-treatment guidance reduce but do not eliminate these limitations. Participant-paid enrollment may reduce generalizability. Daily adherence is measured as use/no-use confirmation rather than exact exposure duration because no suitable reusable duration form is currently available in the platform.

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

The intervention is non-invasive and commercially available, and study procedures consist primarily of product use and questionnaires. Participants are instructed to seek medical evaluation for severe or concerning symptoms. The design avoids diagnostic claims and is intended to evaluate within-person changes in recurring back symptoms and function.

Suitability for Pay to Participate Model

Participants purchase the same WAVwatch product they would otherwise be able to obtain outside the study, while receiving structured study guidance, repeated outcome measurement, personal result reporting, and contribution to generalizable evidence. The study price is set at $597 to remain consistent with the current WavWatch back study configuration.