Lateral EpicondylitisNCT06267027
Comparison of Different Physical Therapy Modalities in Lateral Epicondylitis
A study testing Exercise, Kinesiotaping and High intensity laser therapy in people with Lateral Epicondylitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Exercise, Kinesiotaping and High intensity laser therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 15 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer patients diagnosed with unilateral lateral epicondylitis
Who cannot join
- Those who have previously received treatment for lateral epicondylitis
- Current extremity fracture or surgical history
- Presence of congenital deformity in the upper extremity
- Cervical radiculopathy, myelopathy, plexopathy, entrapment neuropathies
- Presence of neurological disease such as stroke, Parkinson's, multiple sclerosis, epilepsy and muscle disease
- Presence of skin lesion, infection and open wound on the affected extremity
Show all 13Show fewer
- Presence of metal implant in the affected extremity
- Rheumatological disease
- Pregnancy
- Pacemaker presence
- Malignancy
- Cognitive dysfunction
- Presence of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Effects Of Kinesiotaping And High Intensity Laser Therapy In Patients With Lateral Epicondylitis: A Randomized Controlled Study
Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study
Read the detailed description
In this study, it was aimed to compare the effects of exercise therapy, kinesiology taping and high-intensity laser therapy on pain, muscle strength and functional status in patients with LE. Patients who applied to the outpatient clinic of the Sadi Konuk Training and Research Hospital Physical Medicine and Rehabilitation clinic due to elbow pain and were diagnosed with unilateral LE will be included. The study was planned as randomized, prospective and controlled. Patients will be randomized using a random (randomized) numbers table and distributed equally to the groups. Only exercise will be applied to the first group, high-intensity laser therapy and exercise to the second group, and kinesiology taping and exercise treatments to the third group. Sixty people will be included in the study. Patients will be evaluated before treatment, immediately after treatment, and at 4 weeks post-treatment. In the evaluation of the patients, the severity of pain during rest and activity measured with the Visual Analogue Scale (VAS), Quick Disability of the Arm, Shoulder and Hand (QuickDASH), Patient Based Lateral Epicondylitis Evaluation Test - Patient Rated Tennis Elbow Evaluation (PRTEE), Jamar' Hand grip strength will be evaluated with the hand dynamometer.
- Conditions
- Lateral Epicondylitis
- Being tested
- Exercise, Kinesiotaping, High intensity laser therapy
- Keywords
- Lateral epicondylitis, Kinesiotaping, High intensity laser
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The aim of exercise therapy is to stretch and strengthen the wrist extensor and flexor muscles. All study groups were given a home exercise program including stretching and eccentric strengthening exercises. The patient was instructed to start with stretching, and the patient was informed to stretch for 30s by flexing the wrist with the other hand while the shoulder was flexed 90 degrees, the elbow was in extension and the forearm was pronated. When stretching exercises could be performed painlessly, the patient was instructed to move on to strengthening exercises. Eccentric strengthening exercises for wrist extensors and flexors were explained with a support under the forearm and each patient was given a written program supported with visuals. It was emphasized that the exercises should be performed within the pain limit and patients were told to stop if they had severe pain. The exercise program was told to be performed 2 times a day, in 3 sets, 10 repetitions.
KinesiotapingDevice
Area where the tape would be applied was clean and dry. If there is excessive hair in the application area, patients were asked to shave this area. It was explained that cream and similar substances should not be used. Muscle inhibition technique and fascia correction technique were used as the application technique. An X strip of approximately 25 cm and a Y strip of 10 cm in length are prepared as long as the distance between the lateral epicondyle and the wrist. The short arms of the X strip are adhered to the dorsal side of the hand without stretching and the crossed part of the strip is placed on the wrist with maximal stretching. The long arms of the X strip are adhered along the extensor carpi ulnaris and extensor carpi radialis to the lateral epicondyle without stretching. The Y strip was applied using the fascia correction method. The tails of the Y band were applied using an oscillating motion. The taping procedure was applied 2 times a week for 3 weeks for a total of 6 times.
High intensity laser therapyDevice
The elbow area was marked and then the epicondylitis protocol was selected. The epicondylitis protocol consists of 3 phases. Phase 1 and 2 consist of analgesic treatment and phase 3 consists of anti-inflammatory treatment. In phase 1 and phase 2 treatment protocol, 8 W was applied to a circular area with a radius of 1.0 cm for 3 min. In Phase 3 protocol, a dose of 80 J/cm2 at 8 W power was applied and the patient's treatment was completed.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | All study groups will be trained on a home exercise program that includes stretching and eccentric strengthening exercises. Receives: Behavioral: Exercise |
| Kinesiotaping and exercise | Experimental | This study groups will be trained on a home exercise program and kinesiotaping. Kinesiotaping, muscle inhibition and fascia correction techniques will be applied in the forearm as described by Kase et al. Receives: Behavioral: Exercise; Device: Kinesiotaping |
| High intensity laser therapy and exercise | Experimental | This study groups will be trained on a home exercise program and high intensity laser therapy. Receives: Behavioral: Exercise; Device: High intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Tennis Elbow Evaluation (PRTEE)
It consists of pain and function subscales that assess the level of pain in the affected arm in the last 1 week and the degree of difficulty experienced during specific and daily activities. The pain assessment consists of 5 questions and the functional assessment consists of 10 questions, totaling 15 questions. The questions are evaluated with a 10-point Likert scale, as in the VAS, with numbers written side by side from 0 to 10. It is calculated by averaging the pain score and functional score. The total score ranges from 0-100, with a higher score indicating an increase in pain and functional loss. Validation of turkish version is available.
Measured: Initial, Week 3, Week 7
Secondary outcomes (3)
Visual Analogue Scale (VAS)
The VAS is a simple, subjective measurement method used to assess the patient's pain intensity and response to treatment. On a 10 cm chart, patients are asked to indicate the severity of their pain within 24 hours, with 0 representing no pain and 10 representing unbearable pain.
Measured: Initial, Week 3, Week 7
Quick Disabilities of the Arm, Shoulder and Hand (qDASH)
Quick-DASH is a shortened version of the 30-question DASH questionnaire used to assess participation and activity limitations in upper extremity musculoskeletal disorders. Patients strain during activities of daily living in the past week is assessed with 11 questions. Answers are scored from 1 to 5 on a scale from good to bad (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: unable to do at all). The total score ranges from 0-100. Validation of turkish version is available.
Measured: Initial, Week 3, Week 7
Jamar's handheld dynamometer
Hand grip strength was evaluated with the Jamar hand dynamometer recommended by the American Society for Surgery of the Hand. The recommended hand grip strength measurement was evaluated with the patient in a sitting position, shoulder in adduction and neutral rotation, elbow in 90 degree flexion, forearm and wrist in neutral position. The patient's grip strength until the onset of pain is used for measurement. Three measurements are made with a one-minute interval between each measurement and averaged. All measurements were performed in both hands, first on the pain-free arm and then on the side with LE.
Measured: Initial, Week 3, Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Feb 2023
- Primary completion15 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- RANDOMIZED CONTROLLED STUDY
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sibel Caglar Okur, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Sibel CAGLAR, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training HospitalHasan YUKSEL, Study chair, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267027
- Sponsor's protocol ID
- 2022/125
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho YT, Hsu WY, Lin LF, Lin YN. Kinesio taping reduces elbow pain during resisted wrist extension in patients with chronic lateral epicondylitis: a randomized, double-blinded, cross-over study. BMC Musculoskelet Disord. 2018 Jun 19;19(1):193. doi: 10.1186/s12891-018-2118-3.
PubMed 29921250Kaydok E, Ordahan B, Solum S, Karahan AY. Short-term Efficacy Comparison of High-intensity and Low-intensity Laser Therapy in the Treatment of Lateral Epicondylitis: A Randomized Double-blind Clinical Study. Arch Rheumatol. 2019 Apr 24;35(1):60-67. doi: 10.5606/ArchRheumatol.2020.7347. eCollection 2020 Mar.
PubMed 32637921Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002.
PubMed 16059855Haidar SG, Kumar D, Bassi RS, Deshmukh SC. Average versus maximum grip strength: which is more consistent? J Hand Surg Br. 2004 Feb;29(1):82-4. doi: 10.1016/j.jhsb.2003.09.012.
PubMed 14734079Halpern CA, Fernandez JE. The effect of wrist and arm postures on peak pinch strength. J Hum Ergol (Tokyo). 1996 Dec;25(2):115-30.
PubMed 9735592Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.
PubMed 22588743Overend TJ, Wuori-Fearn JL, Kramer JF, MacDermid JC. Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. J Hand Ther. 1999 Jan-Mar;12(1):31-7. doi: 10.1016/s0894-1130(99)80031-3.
PubMed 10192633Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
PubMed 19707766
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Kinesiotaping And High Intensity Laser Therapy In Patients With Lateral Epicondylitis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06267027
- Acronym / sponsor ID
- 2022/125
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral epicondylitis, Kinesiotaping, High intensity laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 Feb 2024 (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.
Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study
Detailed description
In this study, it was aimed to compare the effects of exercise therapy, kinesiology taping and high-intensity laser therapy on pain, muscle strength and functional status in patients with LE. Patients who applied to the outpatient clinic of the Sadi Konuk Training and Research Hospital Physical Medicine and Rehabilitation clinic due to elbow pain and were diagnosed with unilateral LE will be included. The study was planned as randomized, prospective and controlled. Patients will be randomized using a random (randomized) numbers table and distributed equally to the groups. Only exercise will be applied to the first group, high-intensity laser therapy and exercise to the second group, and kinesiology taping and exercise treatments to the third group. Sixty people will be included in the study. Patients will be evaluated before treatment, immediately after treatment, and at 4 weeks post-treatment. In the evaluation of the patients, the severity of pain during rest and activity measured with the Visual Analogue Scale (VAS), Quick Disability of the Arm, Shoulder and Hand (QuickDASH), Patient Based Lateral Epicondylitis Evaluation Test - Patient Rated Tennis Elbow Evaluation (PRTEE), Jamar' Hand grip strength will be evaluated with the hand dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- RANDOMIZED CONTROLLED STUDY
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: ExerciseAll study groups will be trained on a home exercise program that includes stretching and eccentric strengthening exercises. |
| Kinesiotaping and exercise | Experimental | Behavioral: Exercise, Device: KinesiotapingThis study groups will be trained on a home exercise program and kinesiotaping. Kinesiotaping, muscle inhibition and fascia correction techniques will be applied in the forearm as described by Kase et al. |
| High intensity laser therapy and exercise | Experimental | Behavioral: Exercise, Device: High intensity laser therapyThis study groups will be trained on a home exercise program and high intensity laser therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer patients diagnosed with unilateral lateral epicondylitis
Key exclusion criteria (13 listed)
- Those who have previously received treatment for lateral epicondylitis
- Current extremity fracture or surgical history
- Presence of congenital deformity in the upper extremity
- Cervical radiculopathy, myelopathy, plexopathy, entrapment neuropathies
- Presence of neurological disease such as stroke, Parkinson's, multiple sclerosis, epilepsy and muscle disease
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 |
|---|---|---|
| ExerciseThe aim of exercise therapy is to stretch and strengthen the wrist extensor and flexor muscles. All study groups were given a home exercise program including stretching and eccentric strengthening exercises. The patient was instructed to start with stretching, and the patient was informed to stretch for 30s by flexing the wrist with the other hand while the shoulder was flexed 90 degrees, the elbow was in extension and the forearm was pronated. When stretching exercises could be performed painlessly, the patient was instructed to move on to strengthening exercises. Eccentric strengthening exercises for wrist extensors and flexors were explained with a support under the forearm and each patient was given a written program supported with visuals. It was emphasized that the exercises should be performed within the pain limit and patients were told to stop if they had severe pain. The exercise program was told to be performed 2 times a day, in 3 sets, 10 repetitions. | Behavioural | Exercise, High intensity laser therapy and exercise, Kinesiotaping and exercise |
| KinesiotapingArea where the tape would be applied was clean and dry. If there is excessive hair in the application area, patients were asked to shave this area. It was explained that cream and similar substances should not be used. Muscle inhibition technique and fascia correction technique were used as the application technique. An X strip of approximately 25 cm and a Y strip of 10 cm in length are prepared as long as the distance between the lateral epicondyle and the wrist. The short arms of the X strip are adhered to the dorsal side of the hand without stretching and the crossed part of the strip is placed on the wrist with maximal stretching. The long arms of the X strip are adhered along the extensor carpi ulnaris and extensor carpi radialis to the lateral epicondyle without stretching. The Y strip was applied using the fascia correction method. The tails of the Y band were applied using an oscillating motion. The taping procedure was applied 2 times a week for 3 weeks for a total of 6 times. | Device | Kinesiotaping and exercise |
| High intensity laser therapyThe elbow area was marked and then the epicondylitis protocol was selected. The epicondylitis protocol consists of 3 phases. Phase 1 and 2 consist of analgesic treatment and phase 3 consists of anti-inflammatory treatment. In phase 1 and phase 2 treatment protocol, 8 W was applied to a circular area with a radius of 1.0 cm for 3 min. In Phase 3 protocol, a dose of 80 J/cm2 at 8 W power was applied and the patient's treatment was completed. | Device | High intensity laser therapy and exercise |
Primary outcome
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Initial, Week 3, Week 7
It consists of pain and function subscales that assess the level of pain in the affected arm in the last 1 week and the degree of difficulty experienced during specific and daily activities. The pain assessment consists of 5 questions and the functional assessment consists of 10 questions, totaling 15 questions. The questions are evaluated with a 10-point Likert scale, as in the VAS, with numbers written side by side from 0 to 10. It is calculated by averaging the pain score and functional score. The total score ranges from 0-100, with a higher score indicating an increase in pain and functional loss. Validation of turkish version is available.
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Initial, Week 3, Week 7
Quick Disabilities of the Arm, Shoulder and Hand (qDASH)
Time frame: Initial, Week 3, Week 7
Jamar's handheld dynamometer
Time frame: Initial, Week 3, Week 7
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 20 Feb 2024.
- Background: PubMed 29921250Cho YT, Hsu WY, Lin LF, Lin YN. Kinesio taping reduces elbow pain during resisted wrist extension in patients with chronic lateral epicondylitis: a randomized, double-blinded, cross-over study. BMC Musculoskelet Disord. 2018 Jun 19;19(1):193. doi: 10.1186/s12891-018-2118-3.
- Background: PubMed 32637921Kaydok E, Ordahan B, Solum S, Karahan AY. Short-term Efficacy Comparison of High-intensity and Low-intensity Laser Therapy in the Treatment of Lateral Epicondylitis: A Randomized Double-blind Clinical Study. Arch Rheumatol. 2019 Apr 24;35(1):60-67. doi: 10.5606/ArchRheumatol.2020.7347. eCollection 2020 Mar.
- Background: PubMed 16059855Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002.
- Background: PubMed 14734079Haidar SG, Kumar D, Bassi RS, Deshmukh SC. Average versus maximum grip strength: which is more consistent? J Hand Surg Br. 2004 Feb;29(1):82-4. doi: 10.1016/j.jhsb.2003.09.012.
- Background: PubMed 9735592Halpern CA, Fernandez JE. The effect of wrist and arm postures on peak pinch strength. J Hum Ergol (Tokyo). 1996 Dec;25(2):115-30.
- Background: PubMed 22588743Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.
- Background: PubMed 10192633Overend TJ, Wuori-Fearn JL, Kramer JF, MacDermid JC. Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. J Hand Ther. 1999 Jan-Mar;12(1):31-7. doi: 10.1016/s0894-1130(99)80031-3.
- Background: PubMed 19707766Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
- 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.
Sibel CAGLAR principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Hasan YUKSEL study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Kinesiotaping and High intensity laser therapy in people with Lateral Epicondylitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 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 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. 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?
Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: Initial, Week 3, Week 7). 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 NCT06267027, 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 20 Feb 2024.