Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain
CompletedNot applicableNCT03947580
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
1\. Introduction 1.1 Description of the Trial The trial was a monocentric, open, randomized, 3-arm clinical trial that took place at the Department of Orthopaedics of the Karviná Miners' Hospital (Karvinská hornická nemocnice a.s.). The involvement of a maximum total number of 198 patients with chronic lumbar spine pain was planned; the patients were randomly and evenly assigned to one of the 3 treatment groups: 1. Use of the Dvectis Single pad; 2. Use of the Dvectis Double pad; 3. Use of no pad. One sequential interim analysis was planned in the middle of the clinical trial and after this interim analysis, the trial was stopped early due to proven efficacy. The expected period of participation of each patient in the clinical trial was 6 weeks (± 5 days). For an overview of the individual study visits and procedures, study population and other detailed information, see the study protocol. According to the plan, the assessment subject was asked during Visit 1 and Visit 2 about the most intensive pain felt in the last 48 hours (PI). The pain was recorded by the subject in the visual analogue scale (VAS) in CRF under supervision of the investigator. Then the assessment subject recorded the intensity of their pain independently in the Patient Journal daily. 1.2 Primary Objective, Quantity and Hypothesis The primary objective of the clinical trial was to assess the efficacy of using the Dvectis Single pad in comparison to "use of no pad" in patients suffering from chronic lumbar spine pain. PI was the primary quantity. The primary hypothesis was the superiority of Dvectis Single based on a check, assessed based on the difference in PI (PID) between week 2 and week 6 (PID6).
Study details
- Official title
- Clinical Trial Evaluating the Effectiveness and Safety of Dvectis Single and Dvectis Double Pads in Comparison to "no Pad Use" in Patients With Chronic Lumbar Spine Pain
- Conditions
- Back Pain
- Back Disorder
- Disease Lumbar Spine
- Interventions
- Other: Use of the Dvectis Single pad
- Other: Use of the Dvectis Double pad
- Other: Use of no pad
- Sponsor
- DD-Hippero s.r.o.
- Collaborators
- PharmTest s.r.o.; Prague Clinical Services s.r.o.
- Start date
- 2018-04-09
- Primary completion
- 2018-08-20
- Sex
- All
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Czechia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* inclusion criteria: 1. Age 18-65 years. 2. 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. 3. VAS ≥ 40 mm of lumbar spine pain felt in the last 48 hours. * exclusion criteria: 1. Chronic pain caused by diseases other than degenerative diseases of the spine. 2. 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. 3. Physiotherapeutic rehabilitation in the spine planned at the time of participation in the clinical test. 4. Pregnant or breastfeeding woman. 5. Simultaneous participation in another clinical investigation or study. 6. Inability to understand patient Information and unwillingness to cooperate in compliance with the clinical investigation instructions. 7. Unsigned Informed consent. * Criteria for early termination of participation: 1. The subject's wish to end participation. 2. The Occurrence of non-inclusion criteria during the clinical investigation. 3. Occurrence of a serious adverse event or other circumstance where further persistence in the clinical investigation would endanger the subject's health. 4. Impossibility to comply with the clinical investigation plan, e.g. Insufficient compliance with the guidelines by the subject or for organisational reasons. 5. Deterioration of the subject's health status, which will require unauthorised treatment.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03947580