Lateral EpicondylitisNCT03074500
Kinesiotaping in Lateral Epicondylitis
A study testing Kinesiotaping and Exercise in people with Lateral Epicondylitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Kinesiotaping and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2017to 30 Apr 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having had symptoms less than 12 weeks
- Tenderness and pain over lateral epicondylitis
- Provocation of the lateral elbow pain with at least one of the following tests - resisted middle finger extension (Maudley's test), resisted wrist extension or passive stretch of wrist extensors (Mill's test).
Who cannot join
- Cervical spondylosis or radiculopathy
- Diabetes mellitus
- Neuropathy
- Arthritis in the upper extremities
- History of injection and physical therapy for lateral epicondylitis within the last three months
- Pregnancy
- History of surgery or acute trauma in the elbow
- Allergy to tape
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
Read the detailed description
Lateral epicondylitis or tennis elbow is a often-encountered disorder of elbow which is characterized by tenderness and pain over lateral epicondylitis of humerus and grip weakness. The annual incidence of lateral epicondylitis has been reported to be %1-3 in general population. Lateral epicondylitis is commonly associated with repetitive overuse of wrist, activities including strong grip which in turn cause microtears and degenerative changes over the common origin of wrist and finger extensors on lateral epicondyle. New researches have shown that the underlying mechanism is degenerative rather than inflammatory. It has been proposed that the cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength.
Kinesio taping (KT) which is a new application of adhesive taping was designed by Kenzo Kase to avoid unwanted effects of conventional taping such as restricting range of motion (ROM) and limiting functional activities. The recommended tape application methods are outlined in 'Clinical Therapeutic Applications of the Kinesio Taping Method' 8. Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin. In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesized to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli. Another mechanism which is claimed by the proponent of the tape is that convolutions are raised ridges of the tape and the skin that are thought to decompress underlying structures and allow for enhanced circulation by increased subcutaneous space. In the last few years, the use of KT has become increasingly popular in rehabilitation programs as an adjunct in the treatment. However, scientific evidence about its effect is insufficient.
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Kinesiotaping, Sham taping, Exercise
- Keywords
- Kinesio taping, lateral epicondylitis, tennis elbow, treatment
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis
Sham tapingOther
Sham taping will be performed without using any technique
ExerciseOther
Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping | Experimental | Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Receives: Device: Kinesiotaping; Other: Exercise |
| Sham taping | Sham comparator | Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Receives: Other: Sham taping; Other: Exercise |
| Control | Other | Stretching and strengthening exercises of wrist Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
Measured: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Secondary outcomes (6)
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.
Measured: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Rest
Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Measured: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Daily Activity
Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Measured: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Night
Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Measured: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Painless Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.
Measured: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.
Measured: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start10 Mar 2017
- Primary completion1 Apr 2018
- Study completion30 Apr 2018
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 Lateral EpicondylitisStudies 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
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulseren Derya Akyuz, MD,Prof, Study director, Marmara University School of Medicine, PM&R DepartmentEsra Giray, Principal investigator, Marmara University School of Medicine, PM&R Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074500
- Sponsor's protocol ID
- 09.2017.004
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2017
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wegener RL, Brown T, O'Brien L. A randomized controlled trial of comparative effectiveness of elastic therapeutic tape, sham tape or eccentric exercises alone for lateral elbow tendinosis. Hand Therapy 2016;21(4):131-9.
Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.
Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med. 2012 Oct;36(5):681-7. doi: 10.5535/arm.2012.36.5.681. Epub 2012 Oct 31.
PubMed 23185733Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.
PubMed 23796685Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
PubMed 11869609Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.
PubMed 27666156Altan L, Kanat E. Conservative treatment of lateral epicondylitis: comparison of two different orthotic devices. Clin Rheumatol. 2008 Aug;27(8):1015-9. doi: 10.1007/s10067-008-0862-8. Epub 2008 Mar 26.
PubMed 18365136Dilek B, Batmaz I, Sariyildiz MA, Sahin E, Ilter L, Gulbahar S, Cevik R, Nas K. Kinesio taping in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):853-858. doi: 10.3233/BMR-160701.
PubMed 27232082
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03074500
- Acronym / sponsor ID
- 09.2017.004
- Conditions
- Lateral Epicondylitis
- Keywords
- Kinesio taping, lateral epicondylitis, tennis elbow, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
Detailed description
Lateral epicondylitis or tennis elbow is a often-encountered disorder of elbow which is characterized by tenderness and pain over lateral epicondylitis of humerus and grip weakness. The annual incidence of lateral epicondylitis has been reported to be %1-3 in general population. Lateral epicondylitis is commonly associated with repetitive overuse of wrist, activities including strong grip which in turn cause microtears and degenerative changes over the common origin of wrist and finger extensors on lateral epicondyle. New researches have shown that the underlying mechanism is degenerative rather than inflammatory. It has been proposed that the cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength.
Kinesio taping (KT) which is a new application of adhesive taping was designed by Kenzo Kase to avoid unwanted effects of conventional taping such as restricting range of motion (ROM) and limiting functional activities. The recommended tape application methods are outlined in 'Clinical Therapeutic Applications of the Kinesio Taping Method' 8. Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin. In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesized to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli. Another mechanism which is claimed by the proponent of the tape is that convolutions are raised ridges of the tape and the skin that are thought to decompress underlying structures and allow for enhanced circulation by increased subcutaneous space. In the last few years, the use of KT has become increasingly popular in rehabilitation programs as an adjunct in the treatment. However, scientific evidence about its effect is insufficient.
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Device: Kinesiotaping, Other: ExerciseKinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises |
| Sham taping | Sham comparator | Other: Sham taping, Other: ExerciseSham taping without using any techniques every 3 days for 2 weeks in addition to exercises |
| Control | Other | Other: ExerciseStretching and strengthening exercises of wrist |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having had symptoms less than 12 weeks
- Tenderness and pain over lateral epicondylitis
- Provocation of the lateral elbow pain with at least one of the following tests - resisted middle finger extension (Maudley's test), resisted wrist extension or passive stretch of wrist extensors (Mill's test).
Key exclusion criteria (8 listed)
- Cervical spondylosis or radiculopathy
- Diabetes mellitus
- Neuropathy
- Arthritis in the upper extremities
- History of injection and physical therapy for lateral epicondylitis within the last three months
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 |
|---|---|---|
| KinesiotapingKinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis | Device | Kinesiotaping |
| Sham tapingSham taping will be performed without using any technique | Other | Sham taping |
| ExerciseStretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. . | Other | Control, Kinesiotaping, Sham taping |
Primary outcome
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
6 secondary outcomes
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Rest
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Daily Activity
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Night
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Painless Grip Strength
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Grip Strength
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWegener RL, Brown T, O'Brien L. A randomized controlled trial of comparative effectiveness of elastic therapeutic tape, sham tape or eccentric exercises alone for lateral elbow tendinosis. Hand Therapy 2016;21(4):131-9.
- BackgroundKase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.
- Results publication: PubMed 23185733Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med. 2012 Oct;36(5):681-7. doi: 10.5535/arm.2012.36.5.681. Epub 2012 Oct 31.
- Results publication: PubMed 23796685Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.
- Results publication: PubMed 11869609Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
- Results publication: PubMed 27666156Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.
- Results publication: PubMed 18365136Altan L, Kanat E. Conservative treatment of lateral epicondylitis: comparison of two different orthotic devices. Clin Rheumatol. 2008 Aug;27(8):1015-9. doi: 10.1007/s10067-008-0862-8. Epub 2008 Mar 26.
- Results publication: PubMed 27232082Dilek B, Batmaz I, Sariyildiz MA, Sahin E, Ilter L, Gulbahar S, Cevik R, Nas K. Kinesio taping in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):853-858. doi: 10.3233/BMR-160701.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
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.
Gulseren Derya Akyuz, MD,Prof study director
Marmara University School of Medicine, PM&R Department
Esra Giray principal investigator
Marmara University School of Medicine, PM&R Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and Exercise in people with Lateral Epicondylitis, run by Marmara University at 1 site in Turkey (Türkiye).
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 8 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 3 Oct 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 3 Oct 2019). 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?
Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)). 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 NCT03074500, 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 3 Oct 2019.