Important Information

Summary

You are invited to join WavWatch Back Pain Phase II, a 35-day research study evaluating WAVwatch 2.0 for recurring back pain and related daily function. Participation is voluntary. The study costs $597 and includes the WAVwatch 2.0 product and the Efforia study experience.

What You Will Do

For the first 7 days, you will not use the WAVwatch Back Support frequency. You will complete a brief daily back-pain rating and end-of-week questionnaires. Starting on Day 8, you will use the WAVwatch Back Support frequency once daily for 28 days according to normal manufacturer guidance. You will continue a brief daily pain rating, confirm use each day, and complete short weekly outcome and safety assessments.

Purpose

The purpose is to determine whether back pain, pain interference, and physical function change after WAVwatch use compared with your own untreated baseline period.

Risks and Discomforts

Potential concerns include temporary worsening of discomfort, skin irritation, headache, dizziness, distraction, frustration, or other unexpected symptoms. Research evidence regarding WAVwatch is limited, so unknown risks may exist. Stop use and seek appropriate medical care if you experience severe or concerning symptoms. In an emergency, contact local emergency services before contacting Efforia.

Benefits

You may or may not experience improvement. A potential benefit is learning more about your own symptom pattern and response. The study may also contribute to broader evidence about WAVwatch.

Alternatives

You may choose not to participate. WAVwatch and other approaches to back discomfort may be available outside this research study.

Voluntary Participation and Withdrawal

Participation is voluntary, and you may leave the study at any time without losing your legal rights. Refunds and returns are handled according to the applicable Efforia and product return policies.

Privacy

Efforia will use your study data to provide personal results and pooled research findings. Identifiable information will be protected according to Efforia privacy and research procedures, although no system can eliminate all privacy risk.

Costs and Medical Care

You are responsible for the study purchase and for medical care you may seek. Efforia does not promise payment for medical treatment or injury related to participation.

Questions or Concerns

Contact help@efforia.com for study questions, problems, or withdrawal. For questions about your rights as a research participant, contact ethics@efforia.com.