Back PainNCT03947580
Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain
A study testing Use of the Dvectis Single pad, Use of the Dvectis Double pad and Use of no pad in people with Back Pain and Back Disorder, run by DD-Hippero s.r.o. at 1 site in Czechia.
Trial 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.). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Back Disorder, Disease Lumbar Spine
- What is being tested?
- Use of the Dvectis Single pad, Use of the Dvectis Double pad and Use of no pad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 9 Apr 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Introduction
1.1 Description of the Trial
Read more
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:
- Use of the Dvectis Single pad;
- Use of the Dvectis Double pad;
- 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).
Read the detailed description
- Analysed Populations and Number of Subjects
Prior to the statistical analysis, 4 populations were defined in line with the study protocol:
- Population including all randomised subjects (ARS);
- Population of all patient with intention to treat (ITT);
- Population of patients without serious deviation from the clinical trial plan
- 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.
- Conditions
- Back Pain, Back Disorder, Disease Lumbar Spine
- Being tested
- Use of the Dvectis Single pad, Use of the Dvectis Double pad, Use of no pad
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Dvectis Single padOther
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 Double padOther
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 no padOther
Description is not needed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Use of the Dvectis Double pad; Other: Use of no pad |
| Use of no pad | No intervention | Description is not needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 Double pad in comparison to "use of no pad" were evaluated by statistician.
Measured: 6 weeks between visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start9 Apr 2018
- Primary completion20 Aug 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- DD-Hippero s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmTest s.r.o., Prague Clinical Services s.r.o.
- Responsible party
- Sponsor
- Investigators
- Marietta Tesarova, MUDr., Study chair, prague clinical services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947580
- Sponsor's protocol ID
- DVE-17
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03947580
- Acronym / sponsor ID
- DVE-17
- Conditions
- Back Pain, Back Disorder, Disease Lumbar Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DD-Hippero s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- PharmTest s.r.o., Prague Clinical Services s.r.o.
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- Use of the Dvectis Single pad;
- Use of the Dvectis Double pad;
- 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).
Detailed description
- Analysed Populations and Number of Subjects
Prior to the statistical analysis, 4 populations were defined in line with the study protocol:
- Population including all randomised subjects (ARS);
- Population of all patient with intention to treat (ITT);
- Population of patients without serious deviation from the clinical trial plan
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Use of the Dvectis Single pad | Experimental | Other: Use of the Dvectis Single pad, Other: Use of no padThe 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. |
| Use of the Dvectis Double pad | Experimental | Other: Use of the Dvectis Double pad, Other: Use of no padThe 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. |
| Use of no pad | No intervention | –Description is not needed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (13 listed)
- Criteria for early termination of participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Dvectis Single padChange 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 Single pad |
| Use of the Dvectis Double padChange 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 the Dvectis Double pad |
| Use of no padDescription is not needed | Other | Use of the Dvectis Double pad, Use of the Dvectis Single pad |
Primary outcome
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
Time frame: 6 weeks between visits
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.
1 secondary outcome
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
Time frame: 6 weeks between visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta Tesarova, MUDr. study chair
prague clinical services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Dvectis Single pad, Use of the Dvectis Double pad and Use of no pad in people with Back Pain and Back Disorder, run by DD-Hippero s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 weeks between visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.