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Clinical Studies
Click to view Study of subject

Comparison of Custom,Prefabricated Orthoses in Initial Treatment of Proximal Plantar Fasciitis
Outcome Study of Subjects with Insertional Plantar Fasciitis
ViscoHeel - Improvements in the Design of Viscoelastic Heel Orthoses
ViscoHeel - the Viscoelastic Heel Pad for Sports Medicine
Train - Active Supports for the Management of Sports Injuries
The Effect of an Ankle Orthosis on Ankle Range of Motion and Performance
Controlled Trial of an Ankle Support (MalleoTrain) in Acute Ankle Injuries
Effect of a Patellar Realignment Brace On Patellofemoral Relationships: Evaluation With Kinematic MR Imaging
Functional Support - Therapy Of The Knee Joint
The Role of the Knee Brace in the Prevention of Anterior Knee Pain Syndrome
Knee Joint Proprioception In Chronic Polyarthritis
Functional Support - Therapy of the Affected Elbow Joint for the Prevention of Disability
Controlled Trial of a Back Support ('Lumbotrain') in Patients with Non-Specific Low Back Pain

Custom, Prefabricated Orthoses in Initial Treatment of Proximal Plantar Fasciitis
Glenn Pfeffer, M.D., Peter Bacchetti, Ph.D., Johnathan Deland, M.D., Al Lewis, M.D., Robert Anderson, M.D., William Davis, M.D., Richard Alvarez, M.D., James Brodsky, M.D., Paul Cooper, M.D., Carol Frey, M.D., Richard Herrick, M.D., Mark Myerson, M.D., James Sammarco, M.D., Chet Janecki, M.D., Steven Ross, M.D., Michael Bowman, M.D., and Ronald Smith, M.D.

Published in Foot and Ankle International, April 1999

236 patients in 15 Foot and Ankle Centers across the country were evaluated to determine the best and most cost-effective initial treatment of proximal plantar fasciitis.

Patients were divided into five groups. Each group performed Achilles Tendon and Plantar Fascia stretching in a similar manner. One group followed only a stretching program. The other groups each used a different orthotic device including: 1) Tuli Heel Cup; 2) Bauerfeind ViscoSpot; 3) Custom polypropylene medial longitudinal arch support; 4) Hapad Comforthotic.

After 8 weeks of treatment, the patients were reevaluated. The Bauerfeind ViscoSpot used in combination with stretching exercises was the most effective treatment tested, with a 95% success rate. Scores for other methods included: Tuli 88%; Hapad 81%; Stretching alone 72%; Custom orthotic 68%.

The Bauerfeind ViscoSpot was proven the best of all over-the-counter devices tested.

The Bauerfeind ViscoSpot was rated more effective for the initial treatment of heel pain than a custom-made polypropylene orthotic costing $300-$400.

Results showed that using the Bauerfeind ViscoSpot or other prefabricated insert along with stretching exercises was better than stretching alone or using a custom orthosis along with stretching. The authors concluded that, when used with a stretching program, a prefabricated shoe insert is more likely to produce improvement in symptoms as part of the initial treatment of proximal plantar fasciitis than a custom polypropylene orthotic device.

Outcome Study of Subjects with Insertional PlantarFasciitis

Robroy L. Martin, P.T., James J. Irrgang, M.S., P.T., A.T.C., and Stephen F. Conti, M.D.

Published in Foot & Ankle International, December 1998

The purpose of the study was to examine the effect of a standardized treatment regimen on a well-defined group of subjects with insertional plantar fasciitis and examine the effect of subject compliance with different aspects of the regimen on clinical outcome.

A total of 237 subjects were treated over almost a 4-year period. The subjects met the three criteria for inclusion in the study, which were: (1) they were personally seen and evaluated by the attending Orthopedic Surgeon at the University of Pittsburgh Medical Center Foot and Ankle Clinic (2) they had a history consistent with insertional plantar fasciitis and maximal tenderness at the medial calcaneal tubercle (3) they had no coexisting symptomatic foot or ankle problem.

The subjects followed a four-part, non-operative treatment program including the use of oral NSAIDs, one physical therapy session to learn Achilles tendon and plantar fascia stretching exercises, the use of a night splint, and the use of either a custom orthosis or heel cushion. The majority of the heel cushions used were Bauerfeind ViscoSpot heel cushions. If there was no improvement after 4 months of treatment, the subject was offered a steroid injection at the insertion of the plantar fascia and continued the program. If improvement was not seen after 6 months of treatment, surgery was considered.

A mailed survey was used to obtain information from the subjects treated. 157 surveys were returned and analyzed. The average age of the subjects who returned the survey was 45 years old, with 60% being men. The reported outcomes were 51% good (no pain), 33.8% fair (intermittent pain) and 14.6% poor (constant pain), with 87.6% satisfied with the treatment and 81.8% satisfied with the final outcome. 56 subjects were put in Group 1, as being compliant with the night splint, exercises and orthosis/heel cup. 15 Subjects were put in Group 2, which met the same criteria as Group 1 plus the additional criteria of taking the medication as prescribed. 88 subjects did not meet the compliance criteria to be included in either group.

Only a small number of subjects agreed to injection or surgery when offered, even if they had continued heel pain. Only 22.1% of subjects who still had symptoms after 6 months reported receiving an injection, and 10% of these consented to surgery. The authors concluded that most patients would rather deal with occasional discomfort than receive an invasive treatment, including injection or surgery.

The study concludes, in agreement with previous studies, that subjects with insertional plantar fasciitis can obtain good results with a nonsurgical treatment program. Compliance was low, but did not correlate to outcome, with one exception. Patients with chronic conditions who were compliant with the night splint had a better outcome. This study does not conclusively describe what is the most appropriate treatment for this condition. Patient perceptions suggest that stretching, night splints, and orthoses/heel pads are equally important parts of the treatment program.

As far as timing, the results suggest that early, aggressive, nonsurgical treatment within 12 months after the onset of symptoms offers the best chance of a good outcome. There is a lower chance of having a good outcome if subjects had symptoms more than 12 months prior to treatment. Also, subjects were less likely to have a good outcome if their symptoms persisted for more than 12 months after starting this treatment regimen. However, the authors concluded that even patients with prolonged symptoms benefited from a nonoperative treatment program.

The authors concluded that indications for surgery are limited. They recommend that physicians provide education and encouragement to patients with this condition because good results can be obtained, but improvement is slow.

Clinical Studies

Improvements in the Design of Viscoelastic Heel Orthoses

Steven J. Levitz, DPM and Dair Dykyj, PhD, New York, NY

Published in Journal of the American Podiatric Medical Association

The Bauerfeind ViscoSpot, combining the principles of weight redistribution and shock attenuation, was dispensed to 30 subjects with plantar heel pain. The subjects wore the heel orthosis in their shoes for 1 month.

Relief or absence of pain occurred in 73% of the cases, 23% of patients reported virtual cessation of pain, particularly when walking.

Many of the patients that did not report relief using the Bauerfeind ViscoSpot were overweight and did not get relief from other common heel pain treatments, including injections, oral medication, padding and strapping, prescription orthoses, soaking and rest.

The Bauerfeind ViscoSpot is cost-effective and time-efficient for both patients and physicians because numerous return or lengthy visits to a physician for fitting or treatment are not necessary.

The Bauerfeind ViscoSpot offers high patient compliance because it is easy to fit and obtain, convenient to use, and it can be used repeatedly at any later occurrence of pain.

The mechanical properties of the Bauerfeind ViscoSpot, a viscoelastic orthosis fitted with a softer plug under the most common site for heel pain, make it more widely applicable that any single standard mechanical treatment modality.

ViscoHeel - the Viscoelastic Heel Pad for Sports Medicine

Dr. Christian Benezis, Montpellier, France

ViscoHeel N and ViscoHeel K were worn by 204 athletes engaged in various sports activities including track and field, football, basketball, dancing, rugby, tennis, volleyball, handball and others. The athletes suffered from conditions including overexertion of the foot (tendon inflammations, neuralgia of the heel), overexertion of the lumbar spine (mechanical lumbar neuralgia in cases of leg length discrepancies), and pain due to muscle injuries in the pubic bone region, the adductor muscle and the calf triceps (gastrocnemius). Assessments of the athletes' conditions were made on three occasions: On day 0, on day 15 and on day 30.

The data evaluated on the 15th day shows 54% of participants experienced very good or good improvement.
The data evaluated on the 30th day shows 65% of participants (2 out of 3) experienced very good or good improvement
A positive effect of some degree is noted in 80% of the cases.
The heel pads, at 0.6 cm high, enable the heel to be lifted, accordingly providing partial compensation for the difference in the length of the lower limb by relieving the lever arm of the triceps (gastrocnemius)/Achilles tendons/heel-bone/sole system.
The study recommends adding the Bauerfeind ViscoHeel pads to the range of therapeutic measures for complaints of the foot and the triceps and in the lumbosacral region.
The study finds that the Bauerfeind ViscoHeel pads are compatible and adapt well to the active stress of the front part of the foot when subjected to shock loads, exertion of heavy pressure when walking, and other circumstances.
The Bauerfeind ViscoHeel pads are also shown to offer good resistance for different types of training.
The Advantages of using the ViscoHeel pads are listed as:
- Excellent Cushioning
- Excellent adhesion to the sole
- Correct adaption to the heel-bone without slippage
- Making the use of an insole, which presses on the forefoot, unnecessary
- Easy to clean and hygienic

Train-Active Supports for the Management of Sport Injurie

Heinrich Hess, M.D., Saarlouis, Germany

Published in Orthopaedie-Technik, July 1985

The construction, function and indication of the Bauerfeind MalleoTrain, GenuTrain, and EpiTrain Train-Active supports are described.

The Train-Active supports series was developed to avoid disadvantages of existing supports. The design of existing supports often leads to vasoconstriction due to a lack of proximal and distal flares, or muscle atrophy and instability due to restricted movement. Also, supports that are knitted evenly and circularly without elevations generate unnecessarily high pressures at the bony prominences and have no therapeutic effect on the soft tissues of the joint.

The Train-Active supports are anatomically and three-dimensionally knit to achieve the ideal fit for the purpose of preventing venous and lymphatic blocking.

The Train-Active supports feature two-way stretch elastic which means an even pressure distribution is exerted in both directions.

Specially fabricated borders with pressure reduction flares prevent vasoconstriction.

Anatomically contoured silicone inserts are incorporated into the supports to provide support and cushioning. The inserts also provide an intermittent massage which improves blood flow and consequently increases metabolism. This increased circulation in turn promotes faster resorption of edemas, effusions, residual hematomas and other conditions.

Muscular activity and the selected design features prevent atrophy of the musculature.

In the MalleoTrain support, the embedded silicone insert supports the ankle joint anteriorly as well as the Achilles tendon mediolaterally.

The silicone insert in the GenuTrain knee support leaves the patella free and compresses the soft tissue regions, predominantly the proximal recesses and the infrapatellar fat pad.

The EpiTrain elbow support has a silicone insert that cushions bony prominences and build up over soft tissues and simultaneously delivers an intermittent pressure effect upon the radial and ulnar muscle and tendinous transition range producing the desired therapeutic effect for epicondylitis.

Numerous clinical large scale tests have subjectively shown the efficiency of the Train-Active series. These supports are important healing aids in the treatment of chronically irritated joint conditions and in the treatment of sporting and other injuries because they support the active exercise treatment to ensure a more speedy regeneration of joint function.

The Effect of an Ankle Orthosis on Ankle Range of Motion and Performance

J. Preston Wiley, MPE, MD and B.M. Nigg, DrScNat

Published in Journal of Orthopaedic and Sports Physical Therapy, June 1996

12 subjects (4 females, 8 males) with clinically documented ankle sprains were recruited for the study.

Each subject was randomly assigned to one or two testing groups, one group wearing MalleoLoc during the first testing session and no orthosis in the second. The other group was tested in the inverse testing sequence.

Range of motion tests were performed before and after each of the exercise sessions consisting of running a figure-eight course, cycling on a stationary bike, and jogging on a treadmill, both with and without the MalleoLoc ankle orthosis worn.

Jumping performance tests were also performed with and without the ankle joint orthosis before and after the previously described exercise program.

Active inversion was reduced by 44% in the pre-exercise condition and by 35% in the post-exercise condition using MalleoLoc, performing as well or better than the other ankle orthosis discussed in the study.

MalleoLoc reduced inversion significantly under all dorsiflexion and plantar flexion angles tested.

MalleoLoc reduced the other movement degrees of freedom (eversion, dorsiflexion, plantar flexion) only minimally.

MalleoLoc loosening was minimal and statistically insignificant; MalleoLoc maintained the restrictive function before and after exercise and activity.

The results of this study showed that the MalleoLoc ankle joint orthosis did not affect the performance variables for the figure-eight and the jumping tests, whereas reduction of performance has been found in many Air-stirrup orthoses.

MalleoLoc did not affect performance negatively, as can other ankle joint orthosis.

Controlled trial of ankle support (MalleoTrain) in acute ankle injuries

J. O’Hara MB, J.C. Valle-Jones MRCS, LRCP, H. Walsh MB, BS, H. O’Hara MRCS,
N.B. Davey MB, BS, DA Eng, H. Hopkin-Richards MRCOG and R.M. Butcher BA, MB, Bchirs

Published in British Journal of Sports Medicine, 1992

A randomized, controlled-parallel group trial assessed 14 days use of MalleoTrain in 220 patients (118 MalleoTrain, 102 control group) with clinically and radiologically proven acute ankle injuries.

The MalleoTrain group was instructed to wear the support every day. The control group received standard therapy advice on resting the affected joint and wearing a simple support (such as Tubigrip).

Patients maintained daily records that were received by the investigator two weeks later. At that time, patients were clinically examined and improvement was assessed.

Both groups showed progressive, highly significant improvements during the 14 days of observation, in all cases the improvement being greater in the MalleoTrain group.

There was a consistent trend for fewer symptoms in the MalleoTrain group.

The number of patients able to work normally rose in both groups, the MalleoTrain group higher, the percentage changing from 34% to 83%.

Analgesic consumption fell progressively during the trial in both groups and was consistently lower in the MalleoTrain group.

In all four assessments: pain at rest, pain at night, pain during activity and activity limitation, the MalleoTrain group improvements were more significant than the control group.

Ratings of ‘much better’ or ‘cured’ were seen in 88% of the MalleoTrain patients and only 68% in the control group.

At the end of the trial, 88% in the MalleoTrain group were described as ‘normal’ or ‘near normal’ while this only true for 67% in the control group.

95% of all Malleotrain treated patients commented on MalleoTrain positively.

MalleoTrain resulted in greater and more rapid improvement, significantly so in relation to the majority of assessment criteria. Overall assessments were in favor of MalleoTrain.

Effect Of Patellar Realignment Brace On Patellofemoral Relationships:Evaluation With Kinematic MRI Imaging

Frank G. Shellock, PhD, Jerrold H. Mink, MD, Andrew L. Deutsch, MD, James Fox, MD,
Todd Molnar, MD, Ronald Kvitne, MD, Richard Ferkel, MD, Los Angeles, CA. Published in Journal of Magnetic Resonance Inaging, July/August 1994

The Bauerfeind GenuTrain P3 was evaluated in 21 patellofemoral joints with patellar subluxation (13 lateral and 8 medial) by using active-movement, loaded kinematic magnetic resonance (MR) imaging.

By wearing the Bauerfeind GenuTrain P3, 76% (16) of the patellofememoral joints tested demonstrated a qualitative correction of or improvement in patellar subluxation.

Four of the five “failures” occurred in patellofemoral joints that had patella alta and /or dysplasitc bone anatomy which is not surprising. Patellofemoral joints with these abnormalities do not have anatomic features that are conducive to establishing congruency between the patella and the femoral trochlear groove.

The Bauerfeind GenuTrain P3 was able to counteract patellar subluxation in the majority of patellofemoral joints studied, as shown by active-movement, loaded kinematic MR imaging.

The Bauerfeind GenuTrain P3 is useful for conservative treatment of patients with patellofemoral joint pain secondary to patellar malalignment and maltracking.

The Bauerfeind GenuTrain P3 has a viscoelastic silicone insert with a special guide designed to counteract subluxation of the patella.

In follow up, painful symptoms were alleviated or reduced in 67% of the joints wearing the Bauerfeind GenuTrain P3.

To the author’s knowledge, this study reports the first cases in which a patellar realignment brace was used to correct or improve medial subluxation of the patella.

GenuTrain P3 is a rational and useful conservative technique for the correction or improvement of patellar subluxation. GenuTrain P3 can also be useful for the management of symptoms and additional problems that may develop secondary to patellar subluxation, such as significant shear forces and excessive contact stresses that result in lesions and eventual degeneration of the articular cartilage.

The optimal use of the GenuTrain P3 is likely to occur in conjunction with a directed physical rehabilitation program designed to treat patellofemoral dysfunction, as has been seen with the application of other braces.

Functional Support - Therapy Of The Knee Joint

Professor Dr. med. Heinrich Hess, Sarrlouis, Germany

Published in Arztliche Fortbildung, March 1983

The Bauerfeind GenuTrain proved highly successful in an extensive clinical trial program of approximately 600 patients.

Compression and fixation without impairing function are the decisive advantages of the Bauerfeind GenuTrain.

During motion of the knee joint, the built in viscoelastic profiles apply alternating compression to the underlying tissue. This obviously improves the flow of blood in the soft tissues so that edemas are resorbed more quickly and effusion are carried away more rapidly.

It was verified that the fit at the proximal and distal border is more important than the measured circumference around the patella. The reason being this circumference is reduced as a result of better resorption of the effusion very often within a few days of the wearing time.

The Bauerfeind GenuTrain is an active support that only fulfills its purpose when worn during daily exercises.

Lengthy existing effusions, especially due to postoperative irritative conditions, disappear after wearing the Bauerfeind GenuTrain for a short time.

The Role of the Knee Brace in the Prevention of Anterior Knee Pain Syndrome

Shlomo BenGal, MPH, Joseph Lowe, MD, Gideon Mann, MD, Alexander Finsterbush, MD, and Yoav Matan, MD

Published in The American Journal of Sports Medicine, January/February 1997

A prospective study of 60 young athletes (army personnel), 27 in the brace group and 33 in the non-brace control group, underwent a vigorous physical training regimen to determine the efficacy of a knee brace with a silicone patellar support ring (Bauerfeind GenuTrain). Due to dropouts, the results were considered significant only among male brace users.

Data was collected in the 1st and 8th week of the study by investigators who did not know the identity of the candidates. Data included the following: personal estimation of pain levels, orthopedic examination, and documentation of physical fitness levels.

The incidence of anterior knee pain syndrome increased with the intensity of exertion as the study progressed.

There was a significant reduction in the incidence of anterior knee pain syndrome at the end of the study in male athletes who had applied the braces before exercise sessions and in the brace group as a whole, compared with the control group.

The significant reduction of anterior knee pain in brace users may have been because of the support of the patella by the silicone ring with resulting reduction in load and cyclic trauma, as well as increased proprioceptive feedback.

Prophylactic use of the brace did not reduce the ability of the athletes who wore braces to improve their physical fitness parameters in response to exercise.

The data indicates that the use of the brace may be an effective way to prevent the development of anterior knee pain syndrome in people participating in strenuous and intensive physical exercise.

Anterior knee pain in army personnel could lead to considerable loss in manpower hours and some claims for disability pensions. Based on that assumption, use of the knee brace could lower the loss of working hours and decrease medical costs associated with anterior knee pain syndrome.

Knee Joint Proprioception In Chronic Polyarthritis

SS. Sell, J. Zacker, S. Lack, S. Goethe, Tubingen, Germany

Published in Aktuelle Rheumatologie, November 1992

Knee joint proprioception was examined using an active and passive test on 48 knee joints of 30 patients with chronic polyarthritis reliably diagnosed.

A control group of 40 normal patients was equally examined.

In all the test procedures performed, it was discovered that the knee joints that had experienced change due to inflammation had significantly impaired proprioception.

At all stages of the disease, impaired proprioception contributes to a worsening of the overall situation of the joint.

The Bauerfeind GenuTrain “active knee support” clearly improved proprioception in patients with chronically inflammatory diseases of the joint.

In patients with chronically inflammatory articular diseases, the positive effect of the Bauerfeind GenuTrain “active knee support” was observed both in passive and active measurement results.

By wearing the Bauerfeind GenuTrain, proprioception values improved from 11.9 degrees to 9.1 degrees in passive measurement results (reference diagram 3).

By wearing the Bauerfeind GenuTrain, proprioception values improved from 12.4 degrees to 10.4 degrees in active measurement results (reference diagram 3).

Functional Support-Therapy of the affected Elbow Joint for the Prevention of Disability

Manfred Konz (translated by W. Kuehnegger)

Published in Journal Arbeitsmedizin Sozialmedizin Praventivmedzin,

35 workmen with differing activities in a large automobile factory took part in this study. All men could no longer perform their work due to painful motion restriction in the elbow joint. All of the workmen suffered from epicondylitis following acute or chronic strain or trauma.

After fitting EpiTrain , 27 of the 35 workmen (77%) wearing the orthosis were able to continue their previous work complaint-free, with complete freedom from pain.

7 of the 35 men (20%) improved to the point where injections or recuperative work assignments were no longer necessary. They were pain free and capable of work.

Only one man could not remain at work wearing EpiTrain; it became necessary to perform surgery.

Results show that use of EpiTrain is without risk and free from side effects when compared to conventional therapy with injections, immobilization by supports, by bandages or in casts.

By elimination or reduction of pain, it can in many cases avoid a longer lasting or repeatedly recurring disability and is therefore practical and economical.

Controlled Trial of a back support (‘Lumbotrain’) in patients with non-specific low back pain

MJ.C. Valle-Jones, M.R.C.S., L.R.C.P., D. Obst. R.G.O.G., H. Walsh, M.B., B.S., J. O’ Hara, M.V., Ch.B.,
H. O’ Hara, M.R.C.S., L.R.C.P., M.R.G.O.G., M.R.C.G.P., N.B. Davey, M.D., B.S., D.A.,
and H. Hopkin-Richards, M.B., B.S., United Kingdom

Published in Current Medical Research and Opinion, 1992

3216 patients with non-specific low back pain participated in a study to assess the clinical efficacy of a new back support, the Bauerfeind Lumbotrain, as compared to “standard therapy” of rest and lifestyle changes. The Lumbotrain group consisted of 111 patients and the control group consisted of 105 patients. All patients were allowed to take pain medication if necessary. Physicians performed a clinical evaluation before and after the study, and the patients made daily assessments of pain levels for 21 days.

The study shows that there were progressive, significant reductions in mean scores for all the pain and activity criteria in both groups and these were significantly greater in the Lumbotrain group from day 7 onward.

The times taken for reduction of symptom scores to 10% of initial values were significantly less in the Lumbotrain group with a degree of recovery occurring 2 to 4 days more rapidly than in the control group.

A significantly higher proportion of patients in the Lumbotrain group could work normally, as compared to 67% in the control group.

The Lumbotrain group took much less pain medication (median 24.5 doses) than the control group (median 51 doses).

Overall clinical assessment scores were significantly superior in the Lumbotrain group. Improvement was seen in 95% of the cases for the Lumbotrain group, as compared with 77% of the cases in the control group.

At the end of the study, 89% of patients in the Lumbotrain group were considered to have returned to normal, while only 68% of patients in the control group returned to normal.

Of those patients who wore the Lumbotrain, 94% commented positively on it.

It is suggested that because of high patient compliance and significantly greater and more rapid alleviation of symptoms than with conventional measures, the use of Lumbotrain should be considered as a possible valuable aid in the management of patients with non-specific low back pain.

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Outcome Study of Subjects with Insertional PlantarFasciitis

Clinical Studies

Improvements in the Design of Viscoelastic Heel Orthoses

ViscoHeel - the Viscoelastic Heel Pad for Sports Medicine

Train-Active Supports for the Management of Sport Injurie

The Effect of an Ankle Orthosis on Ankle Range of Motion and Performance

Controlled trial of ankle support (MalleoTrain) in acute ankle injuries

Effect Of Patellar Realignment Brace On Patellofemoral Relationships:Evaluation With Kinematic MRI Imaging

Functional Support - Therapy Of The Knee Joint

Functional Support - Therapy Of The Knee Joint

Professor Dr. med. Heinrich Hess, Sarrlouis, Germany

The Role of the Knee Brace in the Prevention of Anterior Knee Pain Syndrome

Knee Joint Proprioception In Chronic Polyarthritis

Functional Support-Therapy of the affected Elbow Joint for the Prevention of Disability

Controlled Trial of a back support (‘Lumbotrain’) in patients with non-specific low back pain

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