Knee OsteoarthritisNCT03715764
Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Care
A study testing Physical therapy assessment and Physician assessment in people with Knee Osteoarthritis, run by Vastra Gotaland Region.
Trial summary
In order to manage the future increase in osteoarthritis consultation, patients with osteoarthritis could be assessed by a physical therapist first, so that other patients with more severe conditions could get faster access to a primary care physician. Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Physical therapy assessment and Physician assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 20 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >38 years old
- Knee pain most of the days the last month
- Crepitus on active motion
- Morning stiffness, duration less than 30 minutes
- The patient has to understand the Swedish language to follow test instructions and to complete the self-administered questionnaires.
Who cannot join
- Already been assessed/diagnosed by a healthcare provider for current knee pain.
- knee pain due to a traumatic cause
- other rheumatic or systemic diseases
- severe somatic or mental disease
- pregnancy.
About this study
Official title: Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Health Care. A Randomized Controlled Study
In order to manage the future increase in osteoarthritis consultation, patients with osteoarthritis could be assessed by a physical therapist first, so that other patients with more severe conditions could get faster access to a primary care physician. In Swedish primary care, physicians and physical therapists are primary assessors for patients with suspected knee osteoarthritis. However, it is unclear if there are any differences between these managements in improving health-related quality of life (HrQoL), pain, physical function and self-efficacy.
There are a limited amount of studies about the impact on HrQoL, pain intensity, self-efficacy and physical performance in patients with knee pain being assessed and evaluated by a physical therapist as a primary assessor.
Read more
The overall purpose of this study is to evaluate the effects on self-rated HrQoL, pain intensity, self-efficacy and physical performance with either a physical therapist or a physician as primary assessor for patients with knee pain within primary health care.
Problem statements
Which effect does a clinical pathway with a physical therapist as primary assessor for patients with knee pain…
- … have on self-rated HrQoL compared with a physician as primary assessor?
- … have on self-rated pain intensity compared with a physician as primary assessor?
- … have on physical performance compared with a physician as primary assessor?
- … have on self-efficacy compared with a physician as primary assessor?
It is expected that this study will show the effects of two different primary assessors for patients with knee pain consulting primary health care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with knee pain in primary health care.
Read the detailed description
Patient Recruitment Recruiters: Primary care centers.
Screening procedure: Nurses at the primary care centers will get information about the study and the screening protocol from the data collector and project leader. There will be contact persons at each recruiting unit that will be responsible for the protocols and to contact the data collector when a patient fulfills all the criteria for participation. The project leader will have regular contact with the contact persons at the recruiting units. All screening protocols will be sent to the data collector. All participants will get orally and written information about the study from the data collector, and patients will provide written informed consent.
Randomization: Using a computer-generated list of random numbers, participants will be randomly assigned to being assessed, diagnosed and treated either by a physiotherapist or a physician first. A project coordinator is included among the health care providers in the study, but will not be involved in the screening procedure nor the data collection. The project coordinator will manage the sequence generation, allocation concealment, enrolment and assignments of participants and keep the concealed randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard (in the same building where the enrolment will be), only available for the project coordinator. The project coordinator reveals the allocation to the participant shortly after the baseline measurement and to the health care providers.
Participants and health care providers in both groups will be aware of the allocated group, whereas data collector, data analyst and statistician will be kept blinded of allocation until completion of all outcome assessments.
The blinded data collector and analyst (is a physical therapist) whom is not involved in assessing diagnosing and treating patients with knee osteoarthritis while the study is conducted.
Data Collection: Measurements will be collected at baseline (before randomization), at 3- , 6- , and at 12 months follow up.
Data management: All data will be coded and managed according to the Data Protection Act (1998:204), which means that all data will be confidential and no unauthorized will have access to the patient registry. The results will be presented at group level, therefore, no individual information can be identified. Data will be saved for at least 10 years to enable audit.
Sample size: To detect a minimal clinical improvement in health related quality of life of 0.121(SD 0.2) on the EQ5D-index, with a two-sided 5% significance level and a power of 80%, a sample size of 50 patients per group will be necessary, given an anticipated dropout rate of 14%.
Statistical analysis: Data will be analyzed descriptively and presented as numbers and percent, mean and standard deviation or median and 25th to 75th percentiles. The primary outcome will be mean change in HrQoL (EQ5D-index and EQ5D-scale) and secondary outcomes will include mean change in pain intensity (VAS), physical performance (30CST) and self-efficacy (ASES-S). The changes in scores for the outcomes will be constructed by calculating raw differences between baseline and the follow ups. For group comparison the Χ2-test will be used for nominal data and Fischer's exact test for small numbers, parametric student t-test for continuous variables and Mann-Whitney's test for ordinal data and at skewed distributions. Statistical analysis will be made in SPSS Windows and the analysis will be applied with intention-to-treat (ITT). The level of significance will be p< 0.05.
- Conditions
- Knee Osteoarthritis
- Being tested
- Physical therapy assessment, Physician assessment
- Keywords
- Knee osteoarthritis, Physical Therapist, Primary assessor, Primary care
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy assessmentOther
Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.
Physician assessmentOther
Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy assessment | Other | Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Receives: Other: Physical therapy assessment |
| Physician assessment | Other | Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Receives: Other: Physician assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The questionnaire contain five dimensions and results in an index ranging from -0,549 to 1 using the UK tariffs. An index of 1 indicate full health.
Measured: 12 months
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The EQ5D-VAS is a visual analogue scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best imaginable health state.
Measured: 12 months
Secondary outcomes (3)
Change From Pain Intensity at 12 Months
The mean pain intensity (over the past month) will be measured by a visual analogue scale (VAS) ranged from 0 which will correspond no pain and 100 the worst imagined pain.
Measured: 12 months
Change From Physical Function at 12 Months
Physical performance will be measured with 30 seconds chair stand test (30CST). Number of chair stands will be counted.
Measured: 12 months
Change From Self-efficacy at 12 Months
Self-efficacy will be assessed with Arthritis Self-Efficacy Scale-Swedish version (ASES-S). Each question range from 10-100, where 10 is very insecure and 100 is very confident. The questionnaire consists three subscales in how patients are experiencing their 1) pain, 2) physical function, 3) other symptoms. Each subscale results in a mean score ranging from 10 to 100 where 10 means very insecure and 100 means very confident.
The results of this outcome measure has not been analysed for publication. This outcome measure were excluded in the first manuscript when submitted to scientific journal and will probably be reported in a second manuscript. Anticipated reporting date is December 2024.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Apr 2013
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lena Nordeman, RPT, PhD, Principal investigator, Research & Development Centre Södra Älvsborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715764
- Sponsor's protocol ID
- 115841rct
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
PubMed 25084132Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
PubMed 16110932Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
PubMed 10515649Fransen M, Edmonds J. Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):807-13. doi: 10.1093/rheumatology/38.9.807.
PubMed 10515639Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Gill SD, de Morton NA, Mc Burney H. An investigation of the validity of six measures of physical function in people awaiting joint replacement surgery of the hip or knee. Clin Rehabil. 2012 Oct;26(10):945-51. doi: 10.1177/0269215511434993. Epub 2012 Feb 9.
PubMed 22324057Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Ho CM, Thorstensson CA, Nordeman L. Physiotherapist as primary assessor for patients with suspected knee osteoarthritis in primary care-a randomised controlled pragmatic study. BMC Musculoskelet Disord. 2019 Jul 13;20(1):329. doi: 10.1186/s12891-019-2690-1.
PubMed 31301739
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Health Care. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03715764
- Acronym / sponsor ID
- 115841rct
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Physical Therapist, Primary assessor, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 17 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to manage the future increase in osteoarthritis consultation, patients with osteoarthritis could be assessed by a physical therapist first, so that other patients with more severe conditions could get faster access to a primary care physician. In Swedish primary care, physicians and physical therapists are primary assessors for patients with suspected knee osteoarthritis. However, it is unclear if there are any differences between these managements in improving health-related quality of life (HrQoL), pain, physical function and self-efficacy.
There are a limited amount of studies about the impact on HrQoL, pain intensity, self-efficacy and physical performance in patients with knee pain being assessed and evaluated by a physical therapist as a primary assessor.
The overall purpose of this study is to evaluate the effects on self-rated HrQoL, pain intensity, self-efficacy and physical performance with either a physical therapist or a physician as primary assessor for patients with knee pain within primary health care.
Problem statements
Which effect does a clinical pathway with a physical therapist as primary assessor for patients with knee pain…
- … have on self-rated HrQoL compared with a physician as primary assessor?
- … have on self-rated pain intensity compared with a physician as primary assessor?
- … have on physical performance compared with a physician as primary assessor?
- … have on self-efficacy compared with a physician as primary assessor?
It is expected that this study will show the effects of two different primary assessors for patients with knee pain consulting primary health care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with knee pain in primary health care.
Detailed description
Patient Recruitment Recruiters: Primary care centers.
Screening procedure: Nurses at the primary care centers will get information about the study and the screening protocol from the data collector and project leader. There will be contact persons at each recruiting unit that will be responsible for the protocols and to contact the data collector when a patient fulfills all the criteria for participation. The project leader will have regular contact with the contact persons at the recruiting units. All screening protocols will be sent to the data collector. All participants will get orally and written information about the study from the data collector, and patients will provide written informed consent.
Randomization: Using a computer-generated list of random numbers, participants will be randomly assigned to being assessed, diagnosed and treated either by a physiotherapist or a physician first. A project coordinator is included among the health care providers in the study, but will not be involved in the screening procedure nor the data collection. The project coordinator will manage the sequence generation, allocation concealment, enrolment and assignments of participants and keep the concealed randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard (in the same building where the enrolment will be), only available for the project coordinator. The project coordinator reveals the allocation to the participant shortly after the baseline measurement and to the health care providers.
Participants and health care providers in both groups will be aware of the allocated group, whereas data collector, data analyst and statistician will be kept blinded of allocation until completion of all outcome assessments.
The blinded data collector and analyst (is a physical therapist) whom is not involved in assessing diagnosing and treating patients with knee osteoarthritis while the study is conducted.
Data Collection: Measurements will be collected at baseline (before randomization), at 3- , 6- , and at 12 months follow up.
Data management: All data will be coded and managed according to the Data Protection Act (1998:204), which means that all data will be confidential and no unauthorized will have access to the patient registry. The results will be presented at group level, therefore, no individual information can be identified. Data will be saved for at least 10 years to enable audit.
Sample size: To detect a minimal clinical improvement in health related quality of life of 0.121(SD 0.2) on the EQ5D-index, with a two-sided 5% significance level and a power of 80%, a sample size of 50 patients per group will be necessary, given an anticipated dropout rate of 14%.
Statistical analysis: Data will be analyzed descriptively and presented as numbers and percent, mean and standard deviation or median and 25th to 75th percentiles. The primary outcome will be mean change in HrQoL (EQ5D-index and EQ5D-scale) and secondary outcomes will include mean change in pain intensity (VAS), physical performance (30CST) and self-efficacy (ASES-S). The changes in scores for the outcomes will be constructed by calculating raw differences between baseline and the follow ups. For group comparison the Χ2-test will be used for nominal data and Fischer's exact test for small numbers, parametric student t-test for continuous variables and Mann-Whitney's test for ordinal data and at skewed distributions. Statistical analysis will be made in SPSS Windows and the analysis will be applied with intention-to-treat (ITT). The level of significance will be p< 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy assessment | Other | Other: Physical therapy assessmentPatients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. |
| Physician assessment | Other | Other: Physician assessmentAllocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >38 years old
- Knee pain most of the days the last month
- Crepitus on active motion
- Morning stiffness, duration less than 30 minutes
- The patient has to understand the Swedish language to follow test instructions and to complete the self-administered questionnaires.
Key exclusion criteria (5 listed)
- Already been assessed/diagnosed by a healthcare provider for current knee pain.
- knee pain due to a traumatic cause
- other rheumatic or systemic diseases
- severe somatic or mental disease
- pregnancy.
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 |
|---|---|---|
| Physical therapy assessmentPrimary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care. | Other | Physical therapy assessment |
| Physician assessmentPrimary assessment, diagnose and treatment by a physician for patients with knee pain in primary care. | Other | Physician assessment |
Primary outcome
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index
Time frame: 12 months
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The questionnaire contain five dimensions and results in an index ranging from -0,549 to 1 using the UK tariffs. An index of 1 indicate full health.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS
Time frame: 12 months
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The EQ5D-VAS is a visual analogue scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best imaginable health state.
3 secondary outcomes
Change From Pain Intensity at 12 Months
Time frame: 12 months
Change From Physical Function at 12 Months
Time frame: 12 months
Change From Self-efficacy at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25084132Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
- Background: PubMed 16110932Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
- Background: PubMed 10515649Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
- Background: PubMed 10515639Fransen M, Edmonds J. Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):807-13. doi: 10.1093/rheumatology/38.9.807.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 22324057Gill SD, de Morton NA, Mc Burney H. An investigation of the validity of six measures of physical function in people awaiting joint replacement surgery of the hip or knee. Clin Rehabil. 2012 Oct;26(10):945-51. doi: 10.1177/0269215511434993. Epub 2012 Feb 9.
- Background: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- Derived from this study: PubMed 31301739Ho CM, Thorstensson CA, Nordeman L. Physiotherapist as primary assessor for patients with suspected knee osteoarthritis in primary care-a randomised controlled pragmatic study. BMC Musculoskelet Disord. 2019 Jul 13;20(1):329. doi: 10.1186/s12891-019-2690-1.
- 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.
Lena Nordeman, RPT, PhD principal investigator
Research & Development Centre Södra Älvsborg
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy assessment and Physician assessment in people with Knee Osteoarthritis, run by Vastra Gotaland Region.
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 5 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 17 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715764, which also lists 8 linked publications.
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 17 Dec 2021.