Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain
Back Pain, Back Disorder, Disease Lumbar Spine
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
inclusion criteria:
- Age 18-65 years.
- The Condition of chronic musculoskeletal pain in the lumbar spine (degenerative diseases of the spine) for at least the last 3 months without a major change in the intensity of pain.
- VAS ≥ 40 mm of lumbar spine pain felt in the last 48 hours.
exclusion criteria:
- Chronic pain caused by diseases other than degenerative diseases of the spine.
- Any condition/disease or medicine found in the medical history of the screening, which in the investigator's opinion could affect the assessment of the intensity of pain.
- Physiotherapeutic rehabilitation in the spine planned at the time of participation in the clinical test.
- Pregnant or breastfeeding woman.
- Simultaneous participation in another clinical investigation or study.
- Inability to understand patient Information and unwillingness to cooperate in compliance with the clinical investigation instructions.
- Unsigned Informed consent.
Criteria for early termination of participation:
- The subject's wish to end participation.
- The Occurrence of non-inclusion criteria during the clinical investigation.
- Occurrence of a serious adverse event or other circumstance where further persistence in the clinical investigation would endanger the subject's health.
- Impossibility to comply with the clinical investigation plan, e.g. Insufficient compliance with the guidelines by the subject or for organisational reasons.
- Deterioration of the subject's health status, which will require unauthorised treatment.
Sites / Locations
- Prague Clinical Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Use of the Dvectis Single pad
Use of the Dvectis Double pad
Use of no pad
The Dvectis Single Dynamic-directional pad is a basic model of the Dvectis product range that provides full functionality based on the dynamic-directional seating principle. The Dvectis Single pad is designed to steer muscle tension during sitting in deep-seated muscles. The Dvectis Single pad is intended to eliminate chronic lumbar spine pain by strengthening the stabilizing muscles.
The Dvectis Double Dynamic-directional pad is based on the Dvectis Single model, but in addition to its dual-chamber design, it provides seating with a more balanced load and a higher dynamic-directional effect. The Dvectis Double pad is designed to create and route muscle tension during sitting in deep-seated muscles. The Dvectis Double is also suitable for soft substrates (sofa, soft chair, etc.). The Dvectis Double Pad is intended to remove chronic lumbar spine pain by strengthening the stabilizing muscles.
Description is not needed