Tennis ElbowBFRNCT04607356
Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment
A study testing Blood Flow Restriction (BFR) and Evidence-informed care in people with Tennis Elbow and Lateral Epicondylitis, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow"). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis
- What is being tested?
- Blood Flow Restriction (BFR) and Evidence-informed care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Jun 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
- Between the ages of 18-65
- Elbow pain for 4 weeks or more
Who cannot join
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
- Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- Current fracture in affected arm
- History of crush injury to affected arm
- Any surgery on affected arm in last 1 year
Show all 21Show fewer
- Surgery within last year on contralateral upper extremity
- History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
- Pregnancy
- Active infection
- Current cancer diagnosis/treatment
- Sickle cell anemia or trait
- Kidney dialysis
- History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
- Inability to consent
- Thromboembolism
- Varicose veins
- Cardiovascular disorders
- Taking anti-coagulant medications
- Bleeding disorder
- Instructed by a physician or medical practitioner that they are not cleared to exercise
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Navy Medical Readiness & Training Command San Diego
San Diego, California, 92134
Tara Haugen, MSOT, 570-856-4375
About this study
Official title: Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").
Read the detailed description
Background: Lateral Epicondylalgia, or "tennis elbow", has been shown to affect up to 3% of the population and is a common musculoskeletal condition which also affects military service members. This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain.
Design: Prospective randomized controlled clinical trial
Methods: Participants, between the ages of 18-65, presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research. Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either (1) a standardized, evidence based rehabilitation program or (2) an exercise volume matched group using personalized blood flow restriction (BFR) exercise.
Upon entry to the program subjects will complete measurements of height, body weight, physical activity level (Marx Activity Scale), annotation of their dominant upper extremity (UE), the patient-rated tennis elbow evaluation (PRTEE) questionnaire, Numerical Pain Rating Scale (NPRS), Patient-Reported Outcome Measurement Information System version 1.2- Global Health (PROMIS scale v1.2- Global Health), and grip strength using the JAMAR dynamometer. At the end of each treatment session subjects will complete the Numerical Pain Rating Scale (NPRS) and the OMNI-Resistance Exercise Scale (OMNI-RES) rating of perceived exertion (RPE) survey.
The standard rehabilitation group will perform active wrist extension, forearm supination, and gripping. These exercises may include isometric, concentric, or eccentric forms of strengthening contingent upon clinical decision making. Specifics of exercise performance (to include magnitude of resistance and volume of exercise) will be documented in the treatment record.
The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The Delphi PTS measures an individual's personalized tourniquet pressure (PTP) using doppler technology similar to a blood pressure cuff. In the BFR exercise condition, subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist.
Participants will be provided in-clinic treatment for a maximum of 12 sessions, one to three treatment sessions weekly, and may be discharged prior to that based upon shared decision making between the participant and therapist. The NPRS, grip strength, PROMIS scale v1.2- Global Health, and PRTEE will be completed at the last clinical appointment, as well as three and six-week, and three and six month follow up appointments. Twelve months following completion of occupational/physical therapy clinical care participants will be contacted and asked to complete a verbal NPRS, PROMIS scale v1.2- Global Health and the PRTEE outcome scale. Additionally, at 12 months following discharge from Physical or Occupational Therapy, the participants' EMR will be reviewed for follow-up visits related to the same condition (LET).
Data Analysis: A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures (grip strength, NPRS, and PRTEE) between the time points of intake, end of occupational/physical therapy treatment, and three and six months post completion of treatment. Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model. Healthcare provider(s) will be analyzed as a co-variate. Microsoft Excel and SPSS will function as the main data analysis instruments.
Clinical Implications: Results of this study are expected to guide clinician's selection of rehabilitation techniques to improve outcomes (increase strength, improve function, and decrease pain), improve mission readiness by earlier return to duty, reduce healthcare service costs, and also reduce lost duty/work time.
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Being tested
- Blood Flow Restriction (BFR), Evidence-informed care
- Keywords
- Physical Therapy, Blood Flow Restriction, Tennis Elbow, Lateral Epicondylalgia
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR)Device
The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise.
Evidence-informed careOther
Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-informed care | Active comparator | Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises. Receives: Other: Evidence-informed care |
| Evidence-informed care + Blood Flow Restriction (BFR) | Experimental | Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises. Receives: Device: Blood Flow Restriction (BFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain
Measured: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Patient-rated tennis elbow evaluation (PRTEE)
Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.
Measured: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Grip Strength
Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.
Measured: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions
Secondary outcomes (1)
Patient-Reported Outcome Measurement Information System version 1.2- Global Health
Looking at mental health factors
Measured: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Mar 2021
- Primary completion15 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Tara Haugen, OTR/L, CBIS, United States Naval Medical Center, San Diego
- Investigators
- Tara Haugen, MSOT, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607356
- Sponsor's protocol ID
- NavalMCSD
- Acronym
- BFR
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PubMed 28259850Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
PubMed 21410544American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.
PubMed 26463594Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.
PubMed 19253083Day JM, Lucado AM, Uhl TL. A COMPREHENSIVE REHABILITATION PROGRAM FOR TREATING LATERAL ELBOW TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):818-829.
PubMed 31598419
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment
- ClinicalTrials.gov ID
- NCT04607356
- Acronym / sponsor ID
- BFR / NavalMCSD
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Keywords
- Physical Therapy, Blood Flow Restriction, Tennis Elbow, Lateral Epicondylalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Oct 2020 (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.
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").
Detailed description
Background: Lateral Epicondylalgia, or "tennis elbow", has been shown to affect up to 3% of the population and is a common musculoskeletal condition which also affects military service members. This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain.
Design: Prospective randomized controlled clinical trial
Methods: Participants, between the ages of 18-65, presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research. Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either (1) a standardized, evidence based rehabilitation program or (2) an exercise volume matched group using personalized blood flow restriction (BFR) exercise.
Upon entry to the program subjects will complete measurements of height, body weight, physical activity level (Marx Activity Scale), annotation of their dominant upper extremity (UE), the patient-rated tennis elbow evaluation (PRTEE) questionnaire, Numerical Pain Rating Scale (NPRS), Patient-Reported Outcome Measurement Information System version 1.2- Global Health (PROMIS scale v1.2- Global Health), and grip strength using the JAMAR dynamometer. At the end of each treatment session subjects will complete the Numerical Pain Rating Scale (NPRS) and the OMNI-Resistance Exercise Scale (OMNI-RES) rating of perceived exertion (RPE) survey.
The standard rehabilitation group will perform active wrist extension, forearm supination, and gripping. These exercises may include isometric, concentric, or eccentric forms of strengthening contingent upon clinical decision making. Specifics of exercise performance (to include magnitude of resistance and volume of exercise) will be documented in the treatment record.
The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The Delphi PTS measures an individual's personalized tourniquet pressure (PTP) using doppler technology similar to a blood pressure cuff. In the BFR exercise condition, subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist.
Participants will be provided in-clinic treatment for a maximum of 12 sessions, one to three treatment sessions weekly, and may be discharged prior to that based upon shared decision making between the participant and therapist. The NPRS, grip strength, PROMIS scale v1.2- Global Health, and PRTEE will be completed at the last clinical appointment, as well as three and six-week, and three and six month follow up appointments. Twelve months following completion of occupational/physical therapy clinical care participants will be contacted and asked to complete a verbal NPRS, PROMIS scale v1.2- Global Health and the PRTEE outcome scale. Additionally, at 12 months following discharge from Physical or Occupational Therapy, the participants' EMR will be reviewed for follow-up visits related to the same condition (LET).
Data Analysis: A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures (grip strength, NPRS, and PRTEE) between the time points of intake, end of occupational/physical therapy treatment, and three and six months post completion of treatment. Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model. Healthcare provider(s) will be analyzed as a co-variate. Microsoft Excel and SPSS will function as the main data analysis instruments.
Clinical Implications: Results of this study are expected to guide clinician's selection of rehabilitation techniques to improve outcomes (increase strength, improve function, and decrease pain), improve mission readiness by earlier return to duty, reduce healthcare service costs, and also reduce lost duty/work time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Evidence-informed care | Active comparator | Other: Evidence-informed careStandardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises. |
| Evidence-informed care + Blood Flow Restriction (BFR) | Experimental | Device: Blood Flow Restriction (BFR)Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
- Between the ages of 18-65
- Elbow pain for 4 weeks or more
Key exclusion criteria (21 listed)
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
- Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- Current fracture in affected arm
- History of crush injury to affected arm
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 |
|---|---|---|
| Blood Flow Restriction (BFR)The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise. | Device | Evidence-informed care + Blood Flow Restriction (BFR) |
| Evidence-informed careEvidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia. | Other | Evidence-informed care |
Primary outcome
Numerical Pain Rating Scale
Time frame: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain
Patient-rated tennis elbow evaluation (PRTEE)
Time frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.
Grip Strength
Time frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions
Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.
1 secondary outcome
Patient-Reported Outcome Measurement Information System version 1.2- Global Health
Time frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Results publication: PubMed 28259850Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
- Results publication: PubMed 21410544Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
- Results publication: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Results publication: PubMed 26463594Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.
- Results publication: PubMed 19253083Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.
- Results publication: PubMed 31598419Day JM, Lucado AM, Uhl TL. A COMPREHENSIVE REHABILITATION PROGRAM FOR TREATING LATERAL ELBOW TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):818-829.
- 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.
Tara Haugen, MSOT principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) and Evidence-informed care in people with Tennis Elbow and Lateral Epicondylitis, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 21 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tara Haugen, MSOT (570-856-4375, tara.a.haugen.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions). The study lists 3 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 NCT04607356, which also lists 6 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 8 Feb 2022.