Back Pain Clinical Trial
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
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).
1. Analysed Populations and Number of Subjects
Prior to the statistical analysis, 4 populations were defined in line with the study
protocol:
1. Population including all randomised subjects (ARS);
2. Population of all patient with intention to treat (ITT);
3. Population of patients without serious deviation from the clinical trial plan
4. Safety population.
Each analysed population was based on a list of its members. Although the treatment group
could have generally been different for each patient in a different population (see the study
protocol and statistical analysis plan), such a case did not occur (as all the patients were
de facto placed in the group to which they were randomized). Therefore the real treatment
group is the same as the randomization treatment group for all patients. This fact is not
discussed further in the document.
1.1 The ARS population
Included all patients who were involved in the clinical trial and randomized. The ARS
population was used for summaries of demographic quantities and other quantities established
during Visit 1 in order to describe the study population.
1.2 ITT Population
In this case, this population was identical to the ARS population. According to the plan, ITT
was not supposed to include those ARS patients for whom no PI data were available and those
patients who entered the study repeatedly. However, such circumstances were not detected. The
ITT population represented the primary analysed population for the assessment of efficacy.
1.3 PPS Population
According to the statistical plan, PPS was to include all ITT patients except for patients
with a serious deviation from the clinical trial plan; a serious deviation includes:
- Failure to meet one or multiple participation criteria;
- Error in treatment allocation;
- Documented use of unauthorized concomitant medication or treatment;
- Missing PI0 value;
- More than 25% missing PI values.
- Serious treatment regimen violation or another serious deviation from the clinical trial
plan.
The monitoring reports and discrepancy report implied:
- No study subject that has not met a participation criterion has been registered;
- No study subject with incorrectly allocated treatment has been identified;
- No use of unauthorized concomitant treatment has been documented;
- There was no PI0 value missing;
- Patients 45, 53 and 94 ended the study early; the number of PI values missing is over
25% (83%).
- The following patients violated the treatment regimen in terms of non-observance of the
minimum time of sitting on the pad (21, 23, 35, 42, 55, 57, 60, 72, 75, 76, 84, 86, 88).
Thus there was a serious deviation from the protocol in 16 study subject, i.e. 15.7%.
The PPS population represented the secondary analyzed population for the assessment of
efficacy. Its task was to demonstrate the robustness of the main clinical trial results. For
this reason, comparisons of the tested group efficacy to the control group were used (in
addition to ITT) in final analyses using PI in order to achieve confirmation of the main
clinical trial conclusions.
1.4 Safety Population
According to the plan, the safety population should have constituted of subjects from ARS,
except for those with whom all contact was lost immediately after Visit 1 and those who were
placed (in reality) in one of the tested groups but were not given a pad.A pad was given to
all patients in the tested groups. All contact was lost with patients 53 and 94 and they were
eliminated from the safety population. Patients in the safety population were analyzed based
on the treatment groups they were really placed in, regardless of what group they had been
randomized to.
1.6. Overview of Analysed Populations and Patient History (Numbers of subjects in treatment
groups and analysed populations)
Dvectis Dvectis No treatment Total Single Double
ARS population 35 34 33 102 ITT population 35 34 33 102 PPS population 29 25 32 86 Safety
population 35 33 32 100
2 Missing Data
In the ARS population analyses, the missing data were be treated as missing according to the
plan, i.e. stated in summaries as total numbers of missing data; however, they were excluded
from the calculations of other statistics. In reality, only the time of sitting on the pad is
of significance. In all analyses of the PI quantities, the method of imputation of the last
observed value (Last Observation Carried Forward - LOCF) was used, in accordance with the
plan. The plans for a situation when the PI1 would be missing were not used since the
situation did not occur. The use of LOCF generally also leads to a bias but with regard to
the observed decrease in the PI values during the patient's participation in the study in the
tested groups, compared to the reference group, such an approach is obviously conservative.
For evaluation of the Oswestry questionnaire, the use of LOCF was planned primarily at the
level of individual questions as well as the use of the scoring manual procedure accounting
for missing values, if any. This procedure was beyond the data administration and statistical
analysis activities since the questionnaire was evaluated by the investigator, entering only
the total score in the patient record sheets. If the total score was missing, it was
processed similarly to the processing of missing values in the ARS population analysis (i.e.
solely elimination from the analysis).
3 Sequential and Final Analysis
The first sequential analysis was performed according to the interim analysis plan and
resulted in early study stopping due to efficacy. A report of the first sequential analysis
results is included in a separate document. Then the final analysis was performed, which is
presented in this report.
4 Characteristic of Study Subject and Treatment Regimen Compliance
For the description of the study population within the sequential interim analysis, summaries
of demographic quantities were calculated and presented, as established before the start of
the treatment in the scope determined by the statistical analysis plan. The summaries were
presented for the respective treatment groups (for all 3 treatment groups). The significance
of the differences in these characteristics was not tested.
The treatment regimen compliance was evaluated by a calculation of aggregate statistics for
the average time of the device use in the course of participation in the study.
For the analyzed quantities, summary statistics were calculated in the respective treatment
groups and as a total. The analyzed ARS population was used.
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