Outcome Studies

Outcome Studies

Over the past thirty years, many outcome studies have been done on the economic and medical treatment effects of our technology. Find a compiled list of significant findings below. A complete research list is provided at the bottom of the page.

Active, Targeted, and Measured Device-Based Therapy for Low Back Pain With the David Spine Concept. Comparison of 2 Treatment Protocols.

Objective
To determine the effectiveness of device–based therapy for low back pain.

Methods 
Two different treatment protocols with David Spine Concept:

  • Extended protocol: 24 sessions, devices: G110, G120, G130, G150.
  • Short protocol: 16 sessions, devices: G110, G120. Patients exercised two times per week with 20-40% load, 20 reps, 4,5-5 sec. rep duration.
  • Outcome measures: disability (ODI), pain (VAS), functional status (strength, ROM).

Outcome
In both programs there was statistically significant improvement in terms of disability, pain, and functional status after treatment.

Langella F, Boido E, Basso S, Bassi C, Biber Z, Vanni D et al. Active, Targeted, and Measured Device-Based Therapy for Low Back Pain With the David Spine Concept. Topics in Geriatric Rehabilitation 2021;37(4):230-238.

Comparisons in Muscle Function and Training Rehabilitation Outcomes Between Avoidance-Endurance Model Subgroups.

Objective
To determine if the avoidance-endurance model subgroups, fear-avoiders (FAR), distress-endurers (DER), eustress-endurers (EER), and adaptive responders (AR), in chronic low back pain differ in physical measures and outcomes after training therapy.

Methods
6-month training intervention with 10 devices for the back muscles, abdominal muscles, and hip adductors, abductors with real time training monitoring from device screens. Training was based on initial test results, resistance increase every 4 weeks. Mean training frequency 1 x week. Assessment pre and post intervention.

Outcome measures: maximum isometric strength (G110, G120, G130), ROM, flexion-relaxation tests, AEQ, RMDQ, PDI, SF-36, IPAQ, VAS.

Outcome
Post training, significant improvements were detected in all subgroups in back-related health. However, the DER and the FAR were found to be more impaired before and after the intervention compared with EER and AR, as indicated by a higher pain intensity, higher disability levels, lower quality of life, and inferior working capacity. even though groups did not differ in physical measures and activity levels at baseline. The results underline the importance of AEM-subgroup-specific interventions.

Fehrmann E, Tuechler K, Kienbacher T, Mair P, Spreitzer J, Fischer L et al. Comparisons in Muscle Function and Training Rehabilitation Outcomes Between Avoidance-Endurance Model Subgroups. The Clinical Journal of Pain 2017;33(10):912-920.

Economic Effects

Therapeutic and economic effects of multimodal back exercise: A controlled multicentre study.

Objective
To examine the cost-effectiveness of a 6-month multimodal back exercise (BE) program for non-specific back pain compared to standard treatment (ST).

Methods
36 training sessions in a span of 24 weeks. Training program consisted of dynamic strength training of the trunk stabilizers and neck muscles (F110, 120, 130, 140, and 150), functional exercises and stretching + home training program after intervention. Follow-up at 6, 12, 18 and 24 months.

Outcome measures: Medical costs (EUR), Graded Chronic Pain Status (GCPS).

Outcome
The BE program significantly reduced the most severe back pain and mean back pain parameters and the function parameters (impairment of daily work, days with pain) → Significant reduction in the mean value GCPS grade of 0.4 in BE compared with ST (2 years post intervention).

Difference in direct medical costs (total costs within two years post intervention) of BE and ST was 763 EUR (16 %), p=0.034 in favor of BE. The therapeutic and economic effects of the program increase with the grade of back pain.

Müller G, Pfinder M, Clement M, Kaiserauer A, Deis G, Waber T et al. Therapeutic and economic effects of multimodal back exercise: A controlled multicentre study. Journal of Rehabilitation Medicine 2019;51(1):61-70.

Cost / benefit analysis of a scientifically supported training for health insurance participants with back problems. The example of the Gothaer Krankenversicherung AG.

Objective
To reduce the high costs of back pain patients through the back training program “integrated functional back pain therapy” implemented according to the FPZ (Research and Prevention Centre / Forschungs- und Präventionszentrum) concept.

Methods
Using the criterion: “spinal column syndrome with major symptoms”, 400 insured parties from the period 2001–2003 were analyzed from which 94 entered the treatment program.

The intervention group underwent 24 training session with David Spine Concept (with initial and outcome analysis).

The services rendered were subjected to a comparative test according to business management criteria with return on investment (ROI).

Outcome
Savings in the intervention group were 5544 EUR on average. Calculated over the period of 4 years from 2000-2003, savings were 1390 EUR per patient per year.

When divided into specific cost criteria, results where more diversified. Between the years 2000-2003 the costs for the insurance company per patient were 17.489,78 EUR in the control group and 11.647,24 EUR in the intervention group. The costs for the back training with 1:1 therapist: patient ratio were 1247,55 EURO.

This shows that over the period of 4 years for total costs a ROI of 4,7:1 was achieved. This means that for every EUR invested into active back training a benefit of 4,7 EUR compared to the control group could be achieved.

Daschner T, Tschubar F. Cost/benefit analysis of a scientifically supported training for health insurance participants with back problems. The example of the Gothaer Krankenversicherung AG. Manuelle Medizin 2006;44(4):308-312.

FPZ Outcome Studies

FPZ focuses on the muscles. For more than 25 years, FPZ has been focusing on the power of muscles to support us and make us strong for life. And give us more healthy years of life.

Physical training and targeted exercise activate processes in the body that have positive effects on health – without any side effects. Your muscles are your “body’s own pharmacy”. That’s why FPZ, the research and prevention center, focuses on your muscles. FPZ supports you on your way to more healthy years of life! Your strong basis for a happy, satisfied and fulfilling life. By 2025, we would like to have enabled a total of 500,000 additional healthy life years.

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Integrated care for back pain: scientific documentation 2006-2008.

Objective
To investigate if integrated care for back patients (FPZ Concept which includes exercise therapy for spine) leads to economical savings in medical costs compared to standard care.

Methods
Comparative data of standard care and integrated care were made following these two criteria:

1.Data was required from insured persons of a health insurance company who did not take part in integrated care.

2.Retrospective results (period before the start of integrated care) and also prospective results (review of the effects) must be available for this data.

For this purpose, the data was retrieved from a large German health insurance company which was a partner of integrated care for back pain from the start.

Outcome
Integrated care showed statistically significant savings in the following areas: doctor visits, medication and remedies and aids. In category “incapacity for work”, integrated care seemed to be successful if it was started before a time limit of 6 weeks off from work.

Overall the average annual saving were €1,562 per patient.

FPZ AG Köln (Hrsg). Integrierte Versorgung Rückenschmerz: Wissenschaftliche Dokumentation 2006–2008. 2009.

The FPZ CONCEPT in company health management.

Objective
To investigate if integrated care for back pain (FPZ Concept) reduces the number of sick days and doctor visits.

Methods
Three month treatment program for strengthening and stabilizing spine (FPZ Concept).

Outcome
There was a 50.81 % reduction in sick days and a 57.09 % reduction in doctor visits in patients who participated into the 3-month treatment program.

Schifferdecker-Hoch, F., Hollmann, M., Hoppe, M. Das FPZ KONZEPT im Betrieblichen Gesundheitsmanagement. FPZ AG, Köln. 2014.

Current figures and findings on the medical and economic effectiveness of Integrated Functional Back Pain Therapy.

Objective
To investigate if integrated care for back pain (FPZ Concept) reduces pain.

Methods
Three month treatment program (24 sessions) for strengthening and stabilizing spine (FPZ Concept).

Outcome
41.2% of all participants in the FPZ 24 program reported to be pain-free after the treatment. Integrated care lowered the pain frequency in 63.3 % of all patients and lowered the pain intensity in 78.1 % of all patients.

Hollmann, M., Niederau, A. Aktuelle Zahlen und Erkenntnisse zur medizinischen und ökonomischen Wirksamkeit der Integrierten Funktionellen Rückenschmerztherapie (FPZ KONZEPT). 2013.

Overview Outcome Studies

David outcome studies with the EVE system
David outcome studies without the EVE system

Future of spine and orthopedic care

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