Rotator Cuff SyndromeNCT05976035
Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain
A study testing Exercise and Supplement in people with Rotator Cuff Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Exercise and Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over the age of 40
- Diagnosing with rotator cuff-related shoulder pain confirming through clinical examination (Hawkins Kennedy and Empty Can tests) and MRI imaging
- Having shoulder pain for at least three months
Who cannot join
- Having full-thickness or massive rotator cuff tear,
- Having a history of symptoms onset due to trauma,
- Having a history of surgery on the same shoulder,
- Having shoulder passive external rotation <30° and flexion <120°,
- Having shoulder instability,
- Having an allergy to any supplement,
Show all 10Show fewer
- Having psychological, emotional, or cognitive problems
- Presence of shoulder problems caused by systemic diseases,
- Presence of diabetes, presence of pregnancy or breastfeeding,
- Malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa
Istanbul, 34500
Derya Çelik, Prof, +905327940169, derya.celik@iuc.edu.tr
About this study
Official title: Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?
Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Many patients continue to experience pain and functional loss for up to one year, and more than half of the patients report shoulder pain persisting for over three years.
The pathophysiology underlying rotator cuff-related shoulder pain continues to be a subject of ongoing research and uncertainty, with many aspects yet to be fully elucidated. The most common belief regarding its pathogenesis involves the role of inflammation. This hypothesis is supported by the accumulation of inflammatory cells in tendons, oxidative stress, and increased levels of pro-inflammatory cytokines. In tendon pathologies with inflammatory cell accumulation and increased cytokine levels, the use of antioxidants and anti-inflammatory agents in addition to conservative treatment contributes to tendon healing. Anti-oxidants and anti-inflammatories are substances capable of preventing or delaying certain cell damage.The use of anti-inflammatory and antioxidant supplements such as Vitamin C (Vit-C), Vitamin D (Vit-D), Omega-3, and Magnesium (Mg) is recommended. Despite indicating exercise as the gold standard for managing rotator cuff-related shoulder pain and the demonstrated anti-inflammatory and anti-oxidant properties of the mentioned supplements, there are still gaps in the understanding of their effectiveness in rotator cuff-related shoulder pain.
Based on these gaps, the goal of this study is to investigate the effects of supplements (Vit-C, Vit-D, Omega-3, and Mg) given in addition to exercise on patients' blood parameters (TNF-a, IL-6, and CRP levels), pain, functional status, quality of life, and patient satisfaction in individuals with rotator cuff-related shoulder pain.
Read the detailed description
58 participants older than 40 years of age with rotator cuff-related shoulder pain for at least 3 months will be included in the study. Signed voluntary consent will be obtained from the patients. Participants will be divided into two groups. Study groups will be as follows: a) Exercise \& Supplement Group and b) Exercise Group.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Exercise, Supplement
- Keywords
- Exercise, Physical Therapy, Anti-oxidant, Anti-Inflammatory
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks
SupplementOther
Receiving supplement that are prescribed by a orthopedist every day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Supplement Group | Active comparator | Exercise \& Supplement group will take supplements that are prescribed by the orthopedist every day for 8 weeks in addition to a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. Receives: Other: Exercise; Other: Supplement |
| Exercise Group | Active comparator | Exercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The scale has range 0 to 10mm. The left side (0mm) shows no pain, and the right side (10mm) shows the most severe pain imaginable. Patients will be asked to mark the severity of their shoulder pain at a point on the scale using this scale. Higher points indicate higher severity and lower points indicate lower severity.
Measured: change from baseline pain at 12 weeks
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Among the self-assessment of the patients, there are 11 items including pain level and functionality. For pain in scoring, they describe pain of increasing severity between 0 and 10; In functionality, a 4-point Likert-type scale is used to determine whether they can perform activities of daily living or not. The total score ranges from 0 (absence of function) to 100 (normal function).
Measured: change from baseline pain at 12 weeks
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
Quick DASH is an 11-item questionnaire used to assess upper extremity functionality. The score ranges from 0 (no injury) to 100 (most severe injury).
Measured: change from baseline pain at 12 weeks
Secondary outcomes (2)
Rotator Cuff Quality of Life (RC-QoL)
It is a self-assessment questionnaire consisting of a total of 34 questions and 5 sections assessing the disease-specific quality of life. Each question is assessed on a 100 mm visual analog scale, with 0 representing the lowest score and 100 the best score, and the total score is given as a percentage. Low scores represent low quality of life.
Measured: 3 times for 12 weeks
Global Rating of Change Scale (GRC)
It is a scale to evaluate patient satisfaction. It is designed to determine the extent to which the patient improves or worsens over time. In our study, the change between the pre-treatment status of the participants and their current status at the 8th and 12th weeks after the treatment will be questioned. In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) will be preferred.
Measured: 3 times for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies 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
- Participants will be divided into two groups with equal numbers by computer randomization method.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Derya Çelik, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976035
- Sponsor's protocol ID
- A-3456789876
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewis J, McCreesh K, Roy JS, Ginn K. Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum. J Orthop Sports Phys Ther. 2015 Nov;45(11):923-37. doi: 10.2519/jospt.2015.5941. Epub 2015 Sep 21.
PubMed 26390274Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107Tashjian RZ. Epidemiology, natural history, and indications for treatment of rotator cuff tears. Clin Sports Med. 2012 Oct;31(4):589-604. doi: 10.1016/j.csm.2012.07.001. Epub 2012 Aug 30.
PubMed 23040548Macfarlane GJ, Hunt IM, Silman AJ. Predictors of chronic shoulder pain: a population based prospective study. J Rheumatol. 1998 Aug;25(8):1612-5.
PubMed 9712108Litchfield R. Progressive strengthening exercises for subacromial impingement syndrome. Clin J Sport Med. 2013 Jan;23(1):86-7. doi: 10.1097/JSM.0b013e31827e9fb5.
PubMed 23269329Vaysman M, Alben M, Todd M, Ruotolo C. Pharmacologic Enhancement of Rotator Cuff Repair: A Narrative Review. Orthop Rev (Pavia). 2022 Sep 4;14(3):37782. doi: 10.52965/001c.37782. eCollection 2022.
PubMed 36072503Yuan T, Qian H, Yu X, Meng J, Lai CT, Jiang H, Zhao JN, Bao NR. Proteomic analysis reveals rotator cuff injury caused by oxidative stress. Ther Adv Chronic Dis. 2021 Mar 17;12:2040622320987057. doi: 10.1177/2040622320987057. eCollection 2021.
PubMed 33796243Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2.
PubMed 32249021Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.
PubMed 22932692Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
PubMed 15866967Cinar-Medeni O, Ozengin N, Baltaci G, Duzgun I. Turkish version of the Rotator Cuff Quality of Life questionnaire in rotator cuff-impaired patients. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):591-5. doi: 10.1007/s00167-014-3290-0. Epub 2014 Sep 11.
PubMed 25209207Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
PubMed 20046623Matthews TJ, Hand GC, Rees JL, Athanasou NA, Carr AJ. Pathology of the torn rotator cuff tendon. Reduction in potential for repair as tear size increases. J Bone Joint Surg Br. 2006 Apr;88(4):489-95. doi: 10.1302/0301-620X.88B4.16845.
PubMed 16567784Millar NL, Hueber AJ, Reilly JH, Xu Y, Fazzi UG, Murrell GA, McInnes IB. Inflammation is present in early human tendinopathy. Am J Sports Med. 2010 Oct;38(10):2085-91. doi: 10.1177/0363546510372613. Epub 2010 Jul 1.
PubMed 20595553
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?
- ClinicalTrials.gov ID
- NCT05976035
- Acronym / sponsor ID
- A-3456789876
- Conditions
- Rotator Cuff Syndrome
- Keywords
- Exercise, Physical Therapy, Anti-oxidant, Anti-Inflammatory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Aug 2023 (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.
Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Many patients continue to experience pain and functional loss for up to one year, and more than half of the patients report shoulder pain persisting for over three years.
The pathophysiology underlying rotator cuff-related shoulder pain continues to be a subject of ongoing research and uncertainty, with many aspects yet to be fully elucidated. The most common belief regarding its pathogenesis involves the role of inflammation. This hypothesis is supported by the accumulation of inflammatory cells in tendons, oxidative stress, and increased levels of pro-inflammatory cytokines. In tendon pathologies with inflammatory cell accumulation and increased cytokine levels, the use of antioxidants and anti-inflammatory agents in addition to conservative treatment contributes to tendon healing. Anti-oxidants and anti-inflammatories are substances capable of preventing or delaying certain cell damage.The use of anti-inflammatory and antioxidant supplements such as Vitamin C (Vit-C), Vitamin D (Vit-D), Omega-3, and Magnesium (Mg) is recommended. Despite indicating exercise as the gold standard for managing rotator cuff-related shoulder pain and the demonstrated anti-inflammatory and anti-oxidant properties of the mentioned supplements, there are still gaps in the understanding of their effectiveness in rotator cuff-related shoulder pain.
Based on these gaps, the goal of this study is to investigate the effects of supplements (Vit-C, Vit-D, Omega-3, and Mg) given in addition to exercise on patients' blood parameters (TNF-a, IL-6, and CRP levels), pain, functional status, quality of life, and patient satisfaction in individuals with rotator cuff-related shoulder pain.
Detailed description
58 participants older than 40 years of age with rotator cuff-related shoulder pain for at least 3 months will be included in the study. Signed voluntary consent will be obtained from the patients. Participants will be divided into two groups. Study groups will be as follows: a) Exercise \& Supplement Group and b) Exercise Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups with equal numbers by computer randomization method.
| Arm | Type | Receives |
|---|---|---|
| Exercise & Supplement Group | Active comparator | Other: Exercise, Other: SupplementExercise \& Supplement group will take supplements that are prescribed by the orthopedist every day for 8 weeks in addition to a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. |
| Exercise Group | Active comparator | Other: ExerciseExercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over the age of 40
- Diagnosing with rotator cuff-related shoulder pain confirming through clinical examination (Hawkins Kennedy and Empty Can tests) and MRI imaging
- Having shoulder pain for at least three months
Key exclusion criteria (10 listed)
- Having full-thickness or massive rotator cuff tear,
- Having a history of symptoms onset due to trauma,
- Having a history of surgery on the same shoulder,
- Having shoulder passive external rotation <30° and flexion <120°,
- Having shoulder instability,
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 |
|---|---|---|
| ExerciseStructured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks | Other | Exercise & Supplement Group, Exercise Group |
| SupplementReceiving supplement that are prescribed by a orthopedist every day for 8 weeks | Other | Exercise & Supplement Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: change from baseline pain at 12 weeks
The scale has range 0 to 10mm. The left side (0mm) shows no pain, and the right side (10mm) shows the most severe pain imaginable. Patients will be asked to mark the severity of their shoulder pain at a point on the scale using this scale. Higher points indicate higher severity and lower points indicate lower severity.
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Time frame: change from baseline pain at 12 weeks
Among the self-assessment of the patients, there are 11 items including pain level and functionality. For pain in scoring, they describe pain of increasing severity between 0 and 10; In functionality, a 4-point Likert-type scale is used to determine whether they can perform activities of daily living or not. The total score ranges from 0 (absence of function) to 100 (normal function).
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
Time frame: change from baseline pain at 12 weeks
Quick DASH is an 11-item questionnaire used to assess upper extremity functionality. The score ranges from 0 (no injury) to 100 (most severe injury).
2 secondary outcomes
Rotator Cuff Quality of Life (RC-QoL)
Time frame: 3 times for 12 weeks
Global Rating of Change Scale (GRC)
Time frame: 3 times for 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 26390274Lewis J, McCreesh K, Roy JS, Ginn K. Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum. J Orthop Sports Phys Ther. 2015 Nov;45(11):923-37. doi: 10.2519/jospt.2015.5941. Epub 2015 Sep 21.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background: PubMed 23040548Tashjian RZ. Epidemiology, natural history, and indications for treatment of rotator cuff tears. Clin Sports Med. 2012 Oct;31(4):589-604. doi: 10.1016/j.csm.2012.07.001. Epub 2012 Aug 30.
- Background: PubMed 9712108Macfarlane GJ, Hunt IM, Silman AJ. Predictors of chronic shoulder pain: a population based prospective study. J Rheumatol. 1998 Aug;25(8):1612-5.
- Background: PubMed 23269329Litchfield R. Progressive strengthening exercises for subacromial impingement syndrome. Clin J Sport Med. 2013 Jan;23(1):86-7. doi: 10.1097/JSM.0b013e31827e9fb5.
- Background: PubMed 36072503Vaysman M, Alben M, Todd M, Ruotolo C. Pharmacologic Enhancement of Rotator Cuff Repair: A Narrative Review. Orthop Rev (Pavia). 2022 Sep 4;14(3):37782. doi: 10.52965/001c.37782. eCollection 2022.
- Background: PubMed 33796243Yuan T, Qian H, Yu X, Meng J, Lai CT, Jiang H, Zhao JN, Bao NR. Proteomic analysis reveals rotator cuff injury caused by oxidative stress. Ther Adv Chronic Dis. 2021 Mar 17;12:2040622320987057. doi: 10.1177/2040622320987057. eCollection 2021.
- Background: PubMed 32249021Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2.
- Background: PubMed 30211382Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Background: PubMed 22932692Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.
- Background: PubMed 15866967Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- Background: PubMed 25209207Cinar-Medeni O, Ozengin N, Baltaci G, Duzgun I. Turkish version of the Rotator Cuff Quality of Life questionnaire in rotator cuff-impaired patients. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):591-5. doi: 10.1007/s00167-014-3290-0. Epub 2014 Sep 11.
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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.
Derya Çelik, Prof. study director
Istanbul University - Cerrahpasa
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 and Supplement in people with Rotator Cuff Syndrome, run by Istanbul University - Cerrahpasa 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 10 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: opening soon, as of the sponsor's last update on 24 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derya Çelik, Prof (+905327940169, derya.celik@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: change from baseline pain at 12 weeks). 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 NCT05976035, which also lists 16 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 24 Mar 2025.