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

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. 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).

Conditions

• Back Pain
• Back Disorder
• Disease Lumbar Spine

Interventions

OTHER

Use of the Dvectis Single pad

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

OTHER

Use of the Dvectis Double pad

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

OTHER

Use of no pad

Description is not needed

Sponsors & Collaborators

• PharmTest s.r.o.

  collaborator INDUSTRY

• Prague Clinical Services s.r.o.

  collaborator UNKNOWN

• DD-Hippero s.r.o.

  lead INDUSTRY

Principal Investigators

• Marietta Tesarova, MUDr. · prague clinical services

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2018-08-20

Completion

2018-12-15

Countries

• Czechia

Study Locations