1. Quantitative Muscle Testing Devices

   Aetna considers the use of quantitative muscle testing devices (e.g., MedX Lumbar and Cervical Extension Devices, Isostation B-200 Lumbar Dynamometer, Kin-Com Physical Therapy Isokinetic Equipment, Cybex Back System, Biodex System 3) experimental and investigational when used for muscle testing because there is insufficient evidence that use of these devices improves the assessment of muscle strength over standard manual strength testing such that clinical outcomes are improved.

   Note: Isokinetic devices (e.g., Biodex, Cybex, and Kin-Com) and other exercise and testing machines (e.g., Isostation B-2000 and MedX) are considered acceptable alternatives for provision of medically necessary exercise in physical therapy.  In addition to use in muscle testing, the MedX and other machines have also been used for administering exercise therapy.  These devices can be used as exercise machines for administering physical therapy.  However, these particular brands of exercise devices have not been proven to be superior to standard brands of exercise equipment (e.g., Nautilus, etc.) when used for administering physical therapy.

2. Orthotrac Pneumatic Vest

   Aetna considers the Orthotrac pneumatic vest, a non-surgical spinal treatment device that has been promoted to relieve back pain of various etiologies, experimental and investigational.

   The Orthotrac is an inflatable pneumatic vest that has been used to relieve back pain from a variety of causes (e.g., herniated disc, spinal stenosis, facet syndrome, spondylolysthesis, etc).  There is insufficient peer-reviewed published clinical evidence of the effectiveness of the Orthotrac pneumatic vest in relieving back pain. 

3. Back School

   Aetna considers back school medically necessary for the treatment of persons with chronic or recurrent back pain, when such a program is prescribed by the member’s doctor and the program is conducted by a physical therapist or other appropriate recognized healthcare professional.  See CPB 0325 - Physical Therapy Services. 

   Note: Back school for occupational purposes may be excluded from coverage.  See CPB 0250 - Occupational Therapy Services; and CPB 0198 - Work Hardening Programs.  Please check benefit plan descriptions for details.

4. Spinal Adjusting Instruments

   See CPB 0107 - Chiropractic Services.

5. Khan Kinetic Treatment

   Aetna considers the Khan Kinetic Treatment experimental and investigational for the treatment of back pain or any other indications because its effectiveness has not been established.

See also CPB 0011 - Electrical Stimulation for Pain, CPB 0016 - Back Pain - Invasive Procedures, CPB 0132 - Biofeedback, CPB 0135 - Acupuncture, CPB 0180 - Vertebral Axial Decompression Therapy, CPB 0204 - Manipulation Under Anesthesia, CPB 0207 - Prolotherapy, and CPB 0569 - Lumbar Traction Devices.

Quantitative Muscle Testing Devices

Muscle strength testing may be used to determine bilateral differences in strength or other differences in patient resistance.  These differences may be characterized by the experienced examiner based on various technologies, i.e., manual, mechanized and computerized muscle testing.  These changes may be a result of alterations of function at various levels of the neuromuscular system and/or any other system related to the patient.  Computerized muscle testing has been used in clinical research to quantify muscle strength and enables the investigator to produce comparison reports, quantifying patient response to rehabilitation and therapy.  However, manual muscle testing is sufficiently reliable for clinical practice.  There is insufficient peer-reviewed published scientific evidence that computerized muscle testing leads to better patient outcomes.

The MedX lumbar/cervical extension machine has been proposed for use for isometric and isokinetic muscle testing and rehabilitation in persons with low back pain (LBP) and/or neck pain.  The MedX lumbar/cervical extension device has not been adequately validated as a test of isometric and isokinetic muscle strength in persons with back or neck pain.  In addition, the MedX machine has not been shown to be superior to any other particular brand of exercise equipment when used for administering physical therapy.  A technology assessment of the MedX Lumbar Extension Machine for the treatment of LBP by the Washington State Department of Labor and Industries (2003) concluded: “The evidence suggests that MedX may help to increase lumbar muscle strength.  However, studies do not clearly show MedX’s efficacy over other exercise programs.”  

Although there is limited evidence that when used as a training device, the MedX system can help to increase the strength of the lumbar as well as the cervical extensors, it has not been proven that the MedX machines are more effective than standard exercise equipment in functional strengthening.  Further investigation, especially controlled studies with pain patients is needed to demonstrate the accuracy of differentiation between normal subjects and patients, especially patients with non-spinal cord injuries of the cervical spine.  Additionally, more research is needed to define the contribution of this equipment to patient management, especially in relation to the significant outcomes of psychological distress, changes in daily activities, and ability to return to work in such patients.

The Isostation B-200 lumbar dynamometry equipment has been suggested for use for the evaluation and rehabilitation of persons with LBP.  Available evidence fails to establish the clinical effectiveness and significance of the use of the Isostation B-200 lumbar dynamometer for isometric and isokinetic muscle testing (spinal motion and trunk function) and rehabilitation in patients with LBP.  More research is needed to establish the ability of this technology to discriminate between normal subjects and patients, to establish test-retest reliability, and to define its contribution to and role in patient management.  Additionally, further research is needed to evaluate the relationship between dynamometric technology, psychological tests and behavior assessments.

The Cybex back system has been proposed for use for evaluation and rehabilitation of persons with LBP.  In addition, the Cybex back system has not been proven to be superior to any other particular brand of exercise equipment for administering physical therapy.

It has not been proven that the Cybex system is more effective than standard exercise equipment in functional strengthening.  More research is needed to increase confidence in interpretation of abnormal range of motion and strength data, to define rehabilitation goals, and more importantly to define the contribution of this equipment to the management of persons with LBP, especially in relation to health outcomes.

Other brands of isokinetic devices used for quantification of muscle strength include the Kin-Com Isokinetic Muscle Testing Device and the Biodex Muscle Testing Device.

In a cross-sectional study, Gruther and colleagues (2009) examined the accuracy and long-term reliability of dynamometric trunk muscle strength and endurance tests in patients with chronic LBP.  A total of 32 patients with chronic LBP, 19 healthy controls and 15 patients with chronic headache matched for age, sex and body mass index were included in the study.  Both patient groups and healthy controls performed isokinetic and isometric trunk extensor and flexor tests on a Biodex 2000 dynamometer.  The Biering-Sørensen test served to examine back muscle endurance.  Borg-Category-Ratio-Scales CR-10 rated participants' body experience immediately before and after the testing.  Patients with chronic LBP repeated measurements after 3 weeks.  Among dynamometric tests, isokinetic measurements revealed the best area under the curve (AUC = 0.89) for the discrimination between patients with chronic LBP and healthy controls.  Reliability testing revealed highly significant learning effects for isometric trunk flexion and isokinetic measurements.  The Biering-Sørensen test demonstrated excellent accuracy (AUC = 0.93) and no learning effects.  Borg-category-ratio-scale ratings were not associated with the observed changes.  The authors concluded that in patients with chronic LBP, dynamometric trunk muscle measures are limited to muscle function assessment purposes.  Monitoring treatment outcome in these patients with these measures appears to be problematic because of learning effects.  Based on these findings, the authors recommended the Biering-Sørensen test for management of chronic LBP rehabilitation.

Khan Kinetic Treatment

The Khan Kinetic Treatment (KKT), manufactured by Datrend Systems Inc (Richmond, British Columbia, Canada), is a medical device for the treatment of spine-related abnormalities causing pain.  According to the manufacturer, the KKT uses high-frequency small-amplitude sinusoidal waves to vibrate the vertebrae and repeatedly activate associated neuromuscular structures, which evoke multiple mechanisms of pain relief.  There is also a small unblinded randomized trial without placebo control, which found that, compared with a control group, the treatment group lowered both their self-recorded neck pain scores (p = 0.012) and pain medication dose (p = 0.048), although current functional assessment questionnaires (range of motion, overall activity, and recreation/work activities) did not detect changes (p = 0.233, 0.311, and 0.472, respectively) (Desmoulin et al, 2007).  Limitations of this study included a lack of blinding and lack of placebo control.  Other published literature on KKT spine treatment consists of a study of the effect of KKT treatment in an animal model (Desmoulin et al, 2010).