Lumbar Herniated DiskNCT03884387
The Use of a Patient Decision Aid in the Choice of Surgery for Herniated Disc
A study testing Patient Decision Aid in people with Lumbar Herniated Disk, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
Even though surgery due to lumbar disc herniation (LDH) shows a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is inconclusive. Involving patients in the decisions whether or not to have surgery is therefore essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Herniated Disk
- What is being tested?
- Patient Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteDenmark
- Study dates
- 22 May 2017to 1 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen by a surgeon in the Center for spine surgery and research, SLB.
- Clinical symptoms and concordant MRI findings of a LDH from L1 to S1 with possible indication for primary discectomy surgery, assessed by an experienced spinal surgeon
- Age >18
- Able to understand and read Danish
- Informed consent
Who cannot join
- General contra-indication for spine surgery
- Diagnosis of psychiatric disorder
- Manifest paresis disorder
- Previous spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Decision Aid in the Choice of Surgery for Herniated Disc
Even though surgery due to lumbar disc herniation (LDH) shows a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is inconclusive. Involving patients in the decisions whether or not to have surgery is therefore essential. A small survey performed at our Spine Center however, showed that patients were often not fully involved in this treatment decision. Not being involved might lead patients to decision regret and unnecessary conflicts in the decision-making process. The purpose of this project is therefore to assess the effect of a newly developed patient decision aid (PtDA) to facilitate shared decision making (SDM), when patients choose between surgical or non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. The project is performed at Center of Spine Surgery \& Research, Middelfart. Inclusion and one month follow up is already completed and one year follow-up data currently being collected.
Read the detailed description
Purpose of the project
The overall purpose of this study is to assess the effectiveness of a generic PtDA-template adapted to patients choosing between surgical and non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. Development of an effective PtDA has the potential to decrease patients' decision regret and optimize treatment results and thereby in the future lead to higher patient satisfaction and fewer patient complaints. Using a generic PtDA-template, makes it feasible to adapt the used method to other spine-departments or other orthopedic-surgeries.
Background
Shared decision making (SDM) is a systematic approach aimed at improving patient involvement in preference-sensitive health care decisions. It is a process, wherein clinicians actively involve patients during the task of making decisions , based on best clinical evidence and patients' informed preferences.
Most people with lumbar disc herniation (LDH) improve with nonsurgical treatment. However, in Denmark, patients with ongoing severe pain and disability after 12 weeks of conservative care are recommended a surgical evaluation. Apart from the presence of a neurologic deficit, there are no clearly defined indications for surgery. A variety of factors, such as level of pain, walking capacity or functional limitations, can influence the judgment of the physician to advocate surgery or not. Indications for surgery are thus assessed, for each particular patient, by the individual surgeon. Even though surgical patients show a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is nevertheless inconclusive. This underlines the concept that the choice of having surgical or non-surgical treatment for LHD is preference sensitive, meaning that treatment options should be offered and should matter to patients. A qualitative study by Andersen showed that the current lack of evidence for a superior treatment choice and the presence of uncertainties in risks and benefits are important to discuss with patients with LDH. Currently, there are no standard procedures used to actively involve patients in such decisions. SDM is required to accomplish the preference sensitive approach for patients with LDH.
Patient decision aids (PtDA) are tools designed to facilitate SDM, and are intended to complement counseling with health professionals. Such a tool could help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of treatment options (or tests), knowledge of treatment outcomes, and by clarifying personal values. Decision Aids compared to usual care seems to improve decision quality and patient knowledge regarding options and reduce their decisional conflict. Some studies also show that PtDAs enable patients to be more actively involved in decision making, and improve the accuracy of risk perceptions when probabilities are included A few English tools have already been designed for patients with LDH. However, these tools were designed to prepare the patients, prior to consultation with a physician and not, as intended in this project, to be used in the clinical encounter. Therefore, prior to this study a PtDAs have been designed and tested for use in spine surgery in a Danish context.
Study 1 - Does the use of a decision aid in a spine surgery clinic facilitate SDM?
Objectives
The Objectives are to determine whether the use of a DA is superior to standard consultation, in terms of:
- Involving and informing the patients in the decision of treatment.
- Minimizing uncertainty, and other conflicting factors, when choosing treatment for herniated disc.
Methods
Design The study will be performed as a randomized controlled trial (RCT). Ten surgeons will be allocated to either using or not using a DA in the surgery clinic, in a 1:1 ratio.
Intervention The intervention is the use of a PtDA for LDH, in a routine doctor-patient consultation, by a trained spine surgeon. All surgeons randomized to use the PtDA will go through a training session held by educators in communication, who is specialized in SDM.
Study population Study subjects will be recruited from Center for Spine Surgery and Research, Lillebaelt Hospital, Middelfart, amongst patients being a candidate for primary discectomy for a LDH from L1-S1.
Data will be collected post consultation in both arms, as the patients exit the consultation.
Statistics (see study 2)
Study 2 - Does the use of a decision aid in a spine surgery clinic improve outcomes?
Objectives
The objectives are to determine if there is a correlation between the use of a DA in the consultation and:
- Better recovery after treatment, measured by leg pain (VAS leg), back pain (VAS back), ODI and EQ5D, one month and one year after spine surgery.
- The level of decisional regret one month and one year after chosen treatment.
Methods
Design, intervention and study-population will be the same as in study 2. However, if patients end up with other surgery than discectomy they will be excluded from the study.
Statistical analysis
As the DQW-HD, DCS, ODI, EQ-5D and VAS Leg and Back pain scores are long ordinal scales, differences in scores, between the groups will be tested using nonparametric Mann-Whitney test for independent samples. Sample size rationale was powered from the main outcome variable in study 3 VAS-leg. Allowing for 30% dropout before completing the study, we need to enroll 70 patients in each arm. All Statistical analyses will be performed using Stata v. 14.0.
Research plan The inclusion started in May 2017. All the patients in the RCT are included and one month follow-up data are collected. Collection of one year follow-up data will has also begun.
Practical framework
All Spine surgeons at the surgery department accepted to participate in the study. Patients were recruited by these surgeons. The research department assists with data-collection at one month and one year follow-up.
Publication and dissemination of results
Results will be published in national and international peer-reviewed journals (i.e. The Spine, The Patient - Patient-Centered Outcomes Research) and presented at national and international conferences (i.e. Dansk Ortopædkirurgisk Selskabs årsmøde (DOS), International Shared Decision Making conference (ISDM), International Conference on Communication in Health Care (ICCH).
Ethical aspects
The study will be conducted according to Danish ethical principles, and notified at the Danish Data Protection Agency. Participants will be given written information about the purpose of the study and will sign an informed consent before the first questionnaires are completed. Surgeons give oral consent. Apart from the use of a PtDA in the consultation, all patients in the study receive "usual care". No changes are made in relation to which clinicians the patients meet or offered treatment.
- Conditions
- Lumbar Herniated Disk
- Being tested
- Patient Decision Aid
- Keywords
- Shared Decision Making, Lumbar Herniated Disk
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision AidOther
Also called Beslutningshjælper©
The Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with lumbar herniated disk. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of having or not having surgery, knowledge of treatment outcomes, and by clarifying personal values.
| Study group | Role | What they receive |
|---|---|---|
| Use of a Patient Decision Aid | Experimental | A Patient Decision Aid is used in this arm in the clinical encounter. A tool designed to facilitate shared decision making when patients choose between surgical and non-surgical treatment for lumbar disc herniation . Receives: Other: Patient Decision Aid |
| Usual counceling | No intervention | Usual counseling in the clinical encounter, when patients choose between surgical and non-surgical treatment for lumbar disc herniation . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)
Decision quality is defined as the extent to which treatments reflect the considered preferences of wellinformed patients and how well it is implemented. Decision quality worksheet - HD include decision-specific items to assess:
- knowledge, or the extent to which patients are informed
- patients' goals, concerns and preferred treatment. These items can then be used to calculate concordance, or the extent to which patients' receive treatments that match their goals.
- the decision making process, or the extent to which providers engage patients in decisions about their care.
The three aspects are reported on separately, as a total knowledge score, a concordance (or in some cases dissonance) score, and a decisions process score.
In this study only the knowledge and the process score is used. A total score is summed for each of the aspects ranging from 0-100 % with higher scores indicating a higher knowledge or a more shared decision- making process respectively.
Measured: Meassured right after the surgeon-patient consultation
Secondary outcomes (5)
Decisional conflict scale
The decisional conflict scale (DCS) measures personal perceptions of:
- uncertainty in choosing options;
- modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and
- effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
A total score is presented ranging from 0-100 with 0 indicating no decisional conflict and 100 extremely high decisional conflict.
Measured: Meassured right after the surgeon-patient consultation
Visual Analog Scale (VAS) leg
The Visual Analogue Scale (VAS) consists of a straight line (10 cm of length) with the endpoints defining the limits 'no pain at all' to the left and 'pain as bad as it could be' to the right. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the patient's pain. A score is given ranging from 0-100 mm. A higher score indicates greater pain intensity.
Measured: One month and one year after decision is made
Decisional Regret Scale
The Decision Regret Scale (a 5-item scale) measures "distress or remorse after a [health care] decision. A total score is presented ranging from 0-100 with 0 indicating no regret and 100 means high regret.
Measured: One month and one year after decision is made
Oswestry Disability Index
This questionnaire has been designed to give information as to how patients back or leg pain is affecting their ability to manage in everyday life. The test is considered the 'gold standard' of low back functional outcome tools. A total score is presented ranging from 0-100 with 0 indicating no regret and 100 means high regret.
Measured: One year after the decision is made
European Quality of life - 5 Dimensions (EQ-5D)
EQ-5D is a standardized/generic measure of health status. It consists of 5 dimensions. Each of the dimensions are divided into 5 levels of perceived problems. A health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5 digit code. In this study an idex value is found using the UK EQ-5D-5L index, which can define 3125 (=55) different health states. The value lies between -0.624 - 1.0, with higher index indicating better health state/quality of life and vice versa. (0.0 indicates death and -0,293 is beeing unconscious).
Measured: One year after decision is made
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start22 May 2017
- Primary completion13 Apr 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Herniated DiskStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Stina Lykke Brogård Andersen, Spine Centre of Southern Denmark
- Investigators
- Stina B Andersen, MHS, Principal investigator, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884387
- Sponsor's protocol ID
- 16/1586
- Status last verified
- Jul 2024
- First submitted
- 3 Jan 2019
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are to be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Decision Aid in the Choice of Surgery for Herniated Disc
- ClinicalTrials.gov ID
- NCT03884387
- Acronym / sponsor ID
- 16/1586
- Conditions
- Lumbar Herniated Disk
- Keywords
- Shared Decision Making, Lumbar Herniated Disk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 22 May 2017 (actual)
- Primary completion
- 13 Apr 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 21 Mar 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.
Even though surgery due to lumbar disc herniation (LDH) shows a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is inconclusive. Involving patients in the decisions whether or not to have surgery is therefore essential. A small survey performed at our Spine Center however, showed that patients were often not fully involved in this treatment decision. Not being involved might lead patients to decision regret and unnecessary conflicts in the decision-making process. The purpose of this project is therefore to assess the effect of a newly developed patient decision aid (PtDA) to facilitate shared decision making (SDM), when patients choose between surgical or non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. The project is performed at Center of Spine Surgery \& Research, Middelfart. Inclusion and one month follow up is already completed and one year follow-up data currently being collected.
Detailed description
Purpose of the project
The overall purpose of this study is to assess the effectiveness of a generic PtDA-template adapted to patients choosing between surgical and non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. Development of an effective PtDA has the potential to decrease patients' decision regret and optimize treatment results and thereby in the future lead to higher patient satisfaction and fewer patient complaints. Using a generic PtDA-template, makes it feasible to adapt the used method to other spine-departments or other orthopedic-surgeries.
Background
Shared decision making (SDM) is a systematic approach aimed at improving patient involvement in preference-sensitive health care decisions. It is a process, wherein clinicians actively involve patients during the task of making decisions , based on best clinical evidence and patients' informed preferences.
Most people with lumbar disc herniation (LDH) improve with nonsurgical treatment. However, in Denmark, patients with ongoing severe pain and disability after 12 weeks of conservative care are recommended a surgical evaluation. Apart from the presence of a neurologic deficit, there are no clearly defined indications for surgery. A variety of factors, such as level of pain, walking capacity or functional limitations, can influence the judgment of the physician to advocate surgery or not. Indications for surgery are thus assessed, for each particular patient, by the individual surgeon. Even though surgical patients show a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is nevertheless inconclusive. This underlines the concept that the choice of having surgical or non-surgical treatment for LHD is preference sensitive, meaning that treatment options should be offered and should matter to patients. A qualitative study by Andersen showed that the current lack of evidence for a superior treatment choice and the presence of uncertainties in risks and benefits are important to discuss with patients with LDH. Currently, there are no standard procedures used to actively involve patients in such decisions. SDM is required to accomplish the preference sensitive approach for patients with LDH.
Patient decision aids (PtDA) are tools designed to facilitate SDM, and are intended to complement counseling with health professionals. Such a tool could help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of treatment options (or tests), knowledge of treatment outcomes, and by clarifying personal values. Decision Aids compared to usual care seems to improve decision quality and patient knowledge regarding options and reduce their decisional conflict. Some studies also show that PtDAs enable patients to be more actively involved in decision making, and improve the accuracy of risk perceptions when probabilities are included A few English tools have already been designed for patients with LDH. However, these tools were designed to prepare the patients, prior to consultation with a physician and not, as intended in this project, to be used in the clinical encounter. Therefore, prior to this study a PtDAs have been designed and tested for use in spine surgery in a Danish context.
Study 1 - Does the use of a decision aid in a spine surgery clinic facilitate SDM?
Objectives
The Objectives are to determine whether the use of a DA is superior to standard consultation, in terms of:
- Involving and informing the patients in the decision of treatment.
- Minimizing uncertainty, and other conflicting factors, when choosing treatment for herniated disc.
Methods
Design The study will be performed as a randomized controlled trial (RCT). Ten surgeons will be allocated to either using or not using a DA in the surgery clinic, in a 1:1 ratio.
Intervention The intervention is the use of a PtDA for LDH, in a routine doctor-patient consultation, by a trained spine surgeon. All surgeons randomized to use the PtDA will go through a training session held by educators in communication, who is specialized in SDM.
Study population Study subjects will be recruited from Center for Spine Surgery and Research, Lillebaelt Hospital, Middelfart, amongst patients being a candidate for primary discectomy for a LDH from L1-S1.
Data will be collected post consultation in both arms, as the patients exit the consultation.
Statistics (see study 2)
Study 2 - Does the use of a decision aid in a spine surgery clinic improve outcomes?
Objectives
The objectives are to determine if there is a correlation between the use of a DA in the consultation and:
- Better recovery after treatment, measured by leg pain (VAS leg), back pain (VAS back), ODI and EQ5D, one month and one year after spine surgery.
- The level of decisional regret one month and one year after chosen treatment.
Methods
Design, intervention and study-population will be the same as in study 2. However, if patients end up with other surgery than discectomy they will be excluded from the study.
Statistical analysis
As the DQW-HD, DCS, ODI, EQ-5D and VAS Leg and Back pain scores are long ordinal scales, differences in scores, between the groups will be tested using nonparametric Mann-Whitney test for independent samples. Sample size rationale was powered from the main outcome variable in study 3 VAS-leg. Allowing for 30% dropout before completing the study, we need to enroll 70 patients in each arm. All Statistical analyses will be performed using Stata v. 14.0.
Research plan The inclusion started in May 2017. All the patients in the RCT are included and one month follow-up data are collected. Collection of one year follow-up data will has also begun.
Practical framework
All Spine surgeons at the surgery department accepted to participate in the study. Patients were recruited by these surgeons. The research department assists with data-collection at one month and one year follow-up.
Publication and dissemination of results
Results will be published in national and international peer-reviewed journals (i.e. The Spine, The Patient - Patient-Centered Outcomes Research) and presented at national and international conferences (i.e. Dansk Ortopædkirurgisk Selskabs årsmøde (DOS), International Shared Decision Making conference (ISDM), International Conference on Communication in Health Care (ICCH).
Ethical aspects
The study will be conducted according to Danish ethical principles, and notified at the Danish Data Protection Agency. Participants will be given written information about the purpose of the study and will sign an informed consent before the first questionnaires are completed. Surgeons give oral consent. Apart from the use of a PtDA in the consultation, all patients in the study receive "usual care". No changes are made in relation to which clinicians the patients meet or offered treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a Patient Decision Aid | Experimental | Other: Patient Decision AidA Patient Decision Aid is used in this arm in the clinical encounter. A tool designed to facilitate shared decision making when patients choose between surgical and non-surgical treatment for lumbar disc herniation . |
| Usual counceling | No intervention | –Usual counseling in the clinical encounter, when patients choose between surgical and non-surgical treatment for lumbar disc herniation . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients seen by a surgeon in the Center for spine surgery and research, SLB.
- Clinical symptoms and concordant MRI findings of a LDH from L1 to S1 with possible indication for primary discectomy surgery, assessed by an experienced spinal surgeon
- Age >18
- Able to understand and read Danish
- Informed consent
Key exclusion criteria (4 listed)
- General contra-indication for spine surgery
- Diagnosis of psychiatric disorder
- Manifest paresis disorder
- Previous spine surgery
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 |
|---|---|---|
| Patient Decision AidAlso: Beslutningshjælper©The Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with lumbar herniated disk. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of having or not having surgery, knowledge of treatment outcomes, and by clarifying personal values. | Other | Use of a Patient Decision Aid |
Primary outcome
Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)
Time frame: Meassured right after the surgeon-patient consultation
Decision quality is defined as the extent to which treatments reflect the considered preferences of wellinformed patients and how well it is implemented. Decision quality worksheet - HD include decision-specific items to assess: 1. knowledge, or the extent to which patients are informed 2. patients' goals, concerns and preferred treatment. These items can then be used to calculate concordance, or the extent to which patients' receive treatments that match their goals. 3. the decision making process, or the extent to which providers engage patients in decisions about their care. The three aspects are reported on separately, as a total knowledge score, a concordance (or in some cases dissonance) score, and a decisions process score. In this study only the knowledge and the process score is used. A total score is summed for each of the aspects ranging from 0-100 % with higher scores indicating a higher knowledge or a more shared decision- making process respectively.
5 secondary outcomes
Decisional conflict scale
Time frame: Meassured right after the surgeon-patient consultation
Visual Analog Scale (VAS) leg
Time frame: One month and one year after decision is made
Decisional Regret Scale
Time frame: One month and one year after decision is made
Oswestry Disability Index
Time frame: One year after the decision is made
European Quality of life - 5 Dimensions (EQ-5D)
Time frame: One year after decision is made
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 23 Jul 2024.
- Individual participant dataSharing planned: No. No IPD are to be shared with other researchers
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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.
Stina B Andersen, MHS principal investigator
Sygehus Lillebaelt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid in people with Lumbar Herniated Disk, run by Spine Centre of Southern Denmark at 1 site in Denmark.
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 5 inclusion and 4 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 23 Jul 2024. 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 Denmark. 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?
Decision Quality worksheet -for herniated disc (DQW-HD v.2.0) (time frame: Meassured right after the surgeon-patient consultation). 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 23 Jul 2024.