Scientific Evidence
Device-Based Exercise Therapy
Our principles are based on scientific facts and findings. This applies to both biomechanics in device designs as well as to training principles. We have conducted several validation and outcome studies over the past 25 years. These pages provide you with studies relating to biomechanics, medical outcomes, and economics.
The majority of the research is third-party publications carried out using Spine Rehab Technology – David devices. The David devices are classified as Electromechanical rehabilitation devices (Medical Class 1m) with measuring function (Directive 93/42/EEC).
The Foundation for our Technology
Our philosophy is based on the latest scientific findings for exercise therapy. The most recent medical guidelines recommend active rehabilitation as first-line treatment for musculoskeletal disorders. Device-based medical exercise therapy enables healthcare professionals to improve care in a targeted and effective way. This supporting studies section presents evidence that justifies the use of exercise therapy as treatment for musculoskeletal disorders.
Effective treatment options for musculoskeletal pain in primary care: a systematic overview of current evidence.
Objective
To identify the current best evidence on treatment options for the five most common musculoskeletal pain presentations (back, neck, shoulder, knee, and multi-site pain) in primary care.
Methods
Systematic literature review, included studies (n=146)
Quality assessment performed using AMSTAR
Strength of evidence evaluated using a modified GRADE approach
Outcome
Best available evidence shows that patients with musculoskeletal pain problems in primary care can be managed effectively with non-pharmacological treatments such as exercise therapy, self-management advice, and psychosocial interventions. For the short-term pain relief, corticosteroid injections (for knee and shoulder pain) can be effective treatment options and may be used in addition to non-pharmacological treatments.
Babatunde O, Jordan J, Van der Windt D, Hill J, Foster N, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLOS ONE 2017;12(6):e0178621.
If exercise is medicine, why don’t we know the dose? An overview of systematic reviews assessing reporting quality of exercise interventions in health and disease
Objective
To determine how well exercise interventions are reported in trials in health and disease.
Methods
Reviews of any health condition were included if they primarily assessed quality of exercise intervention reporting using the Consensus on Exercise Reporting Template (CERT) or the Template for Intervention Description and Replication (TIDieR). The review quality was assessed using a modified version of A MeaSurement Tool to Assess systematic Reviews (AMSTAR).
Outcome
Exercise interventions are poorly reported across a range of health conditions. If exercise is medicine, then how it is prescribed and delivered is unclear, potentially limiting its translation from research to practice.
Hansford H.J, Wewege M.A, Cashin A.G, Hagstrom A.D, Clifford B.K, McAuley J.H, Jones M.D. If exercise is medicine, why don’t we know the dose? An overview of systematic reviews assessing reporting quality of exercise interventions in health and disease. British Journal of Sports Medicine, 2022.
Validation Studies
Isometric reliability test
Objective
To investigate the reliability of mobility measurement and isometric strength measurement in David spine devices.
Method
Measurements were performed on three different days by an experienced tester. The time interval between each examination day was 72 hours. Tests were performed with David Spine devices.
Outcome
The isometric strength measurements showed a strong correlation (r=0.94-0.99). Also the correlation in mobility measurements (in those movement direction where it was measured) was strong (r=0.90-0.98).
Denner A. Muskuläre Profile der Wirbelsäule. Berlin, Heidelberg; Springer; 1997. Chapter 7.4, Ergebnisse Eigener Reliabilitäts- und Validitätsuntersuchungen; p. 163–178.
Muscle activity in target muscles in different movement directions of the spine
Objective
To analyze the muscle activity of the target muscles compared to other muscles in David Spine devices.
Methods
EMG was used to test the isolation of target muscles during maximal isometric contraction. In 110 and 130 devices also muscle activation during submaximal dynamic muscle work (70% of 1 RM) was tested.
Outcome
Fixation in David Spine devices seems to effectively activate target muscles and inhibit other muscles.
Denner A. Muskuläre Profile der Wirbelsäule. Berlin, Heidelberg; Springer; 1997. Chapter 7.4, Ergebnisse Eigener Reliabilitäts- und Validitätsuntersuchungen; p. 163–178.
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.
Economic Effects
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.
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.
