sEMG Division Research Protocol

Demonstration of the clinical efficacy of sEMG biofeedback for pain: A database approach

Summary: While numerous small studies and case series have been published, there is still very little large-scale data supporting the efficacy of sEMG biofeedback for pain and urinary incontinence. Until data from hundreds of patients are published, sEMG biofeedback for pain and urinary incontinence will continue to suffer from low credibility in the mainstream clinical community. This database is intended to partially rectify the problem by providing a way for any practitioner using sEMG biofeedback to treat several pain problems (headache, low back pain, phantom pain.) and/or urinary incontinence to prospectively but anonymously enter data on this web site to build a multipractitioner data base of treatment efficacy.

Practitioners are asked to enter three sets of data for each patient they treat. The first time data are entered is when a patient is referred to the practitioner. The practitioner fills out a brief form taking less than one minute to complete in which includes the patient's diagnosis, how the diagnosis was made, intensity of the symptoms, intensity of disability, and the treatment approach to be used. If this is the practitioner's first time entering data, an anonymous practitioner number is assigned. The case is automatically assigned a sequential number. When the practitioner has completed treatment, the practitioner visits the site again, enters the case number, and fills in a second brief form which requires information including whether the patient completed the treatment, number of sessions, whether the patient learned the skills, and change in symptoms and disability. The third visit is a six-month follow-up. There is no way to associate a particular provider with a particular patient.

Strengths of the study include:

1. the results of many cases can be gathered quickly and
2. because practitioners enter data about each patient at the start of treatment, they cannot simply report the results of successful cases while leaving out the failures.

Weaknesses of the study include:

1. practitioners may not be honest about the results of their treatments,
2. no independent assessment of treatment success is made through anonymous patient reports, etc. and
3. many different treatment approaches will be used.

The database is available in "read-only" format to anyone who wishes to view it.

When entering patient data, please remember:

• Data for each patient will only be saved when all the data for the treatment period you are entering is completed. It will not be saved if you stop mid-way through a treatment period;
• The form will not accept the % symbol, so please do not use it when entering percentage data. The percent is implied;
• Whe reporting SEMG levels, report the average resting baseline number of microvolts (without biofeedback). Do not enter less than whole numbers for microvolt levels as we are only interested in significant changes.

View the Database

For questions about this study, contact Dr. Rich Sherman at rsherman@nwinet.com