Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain

NCT03947580 | Completed

• 1 other identifier: DVE-17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Use of the Dvectis Single pad;
2. 2.Use of the Dvectis Double pad;
3. 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.

Conditions

Back Pain; Back Disorder; Disease Lumbar Spine

Outcome Measures

Primary Outcomes (1)

• Change of pain intensity of using the Dvectis Single pad in comparison to "use of no pad" in patients at Visit 1 and Visit 2

  Pain intensity was measured on a 100 mm Visual Analogue Scale (VAS). VAS is a graphic record where the patient indicates the intensity of pain on a 100 mm long line, where 0 mm means no pain and 100 mm means unbearable pain. The degree of pain intensity is the distance from the left end of the line to the patient indicated by the value in millimeters. The participating subject was asked for experiencing the greatest pain in the last 48 hours during the Visit 1 and Visit 2. The pain was recorded by the subject under supervision of the investigator at Visit 1 and Visit 2. Change of VAS values in mm (0-100mm) between Visit 1 and 2 was evaluated for all subjects. Finaly the overall changes of pain intensity of patients using the Dvectis Single pad in comparison to "use of no pad" were evaluated by statistician.

  6 weeks between visits

Secondary Outcomes (1)

• Change of pain intensity of using the Dvectis Double pad in comparison to "use of no pad" in patients at Visit 1 and Visit 2

  6 weeks between visits

Other Outcomes (4)

• Number and categorization of adverse events of each patient

  6 weeks

• Number and categorization of deficiencies of the medical device in patients enrolled in treatment groups using Dvectis Single or Dvectis Double pad

  6 weeks

• Number of patients with adverse events

  6 weeks (one patient)

Study Arms (3)

Use of the Dvectis Single pad

EXPERIMENTAL

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.

Other: Use of the Dvectis Single pad; Other: Use of no pad

Use of the Dvectis Double pad

EXPERIMENTAL

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.

Other: Use of the Dvectis Double pad; Other: Use of no pad

Use of no pad

NO INTERVENTION

Description is not needed

Interventions

Use of the Dvectis Single pad OTHER

Change in pain intensity - range of VAS (mm) between Visit 1 and Visit 2 Dvectis Single pads compared to "without using a pad".

Use of the Dvectis Single pad

Use of the Dvectis Double pad OTHER

Change in pain intensity - range of VAS (mm) between Visit 1 and Visit 2 Dvectis Double pad compared to "without using a pad", * Categorisation of adverse events, * Categorisation of deficiencies of a medical device in patients enrolled in treatment groups using Dvectis Single and Dvectis Double pad, * Number of patients with adverse events, * Number of patients with deficiencies of medical device enrolled in treatment groups using Dvectis Single and Dvectis Double

Use of the Dvectis Double pad

Use of no pad OTHER

Description is not needed

Use of the Dvectis Double pad; Use of the Dvectis Single pad

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DD-Hippero s.r.o.: lead
• PharmTest s.r.o.: collaborator
• Prague Clinical Services s.r.o.: collaborator

Study Sites (1)

Prague Clinical Services

Prague, Praha 4, 140 00, Czechia

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marietta Tesarova, MUDr.

  prague clinical services

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 13, 2019
• Study Start: April 9, 2018
• Primary Completion: August 20, 2018
• Study Completion: December 15, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)