Rotator Cuff TearsNCT04154592
The Effect of Humeral Head Depressor Muscle Co-Activation Training in Terms of Functional Outcomes
A study testing Humeral Head Depressor Muscle Co-Activation Training- Experimental Group in people with Rotator Cuff Tears and Surgery, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Recent systematic reviews, and meta-analyses concluded that rotator cuff and scapular strengthening exercises should be included in rehabilitation programs for patients with middle-size rotator cuff muscle tear. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Surgery
- What is being tested?
- Humeral Head Depressor Muscle Co-Activation Training- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2020to 20 Jan 2021
- 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
- the presence of middle-sized (1-3 cm) rotator cuff muscle rupture,
- undergoing arthroscopic repair surgery,
- volunteering to participate in the study.
Who cannot join
- presence of diabetic mellitus,
- stage 3 and above according to Goutallier classification,
- presence of any contraindication for mobilization (hypermobility, trauma, inflammation, etc.),
- visual, verbal, cognitive defects (aphasia, unilateral neglect, etc.),
- the presence of any neurological problem,
- the presence of cervical disc hernia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Humeral Head Depressor Muscle Co-Activation Training on Functional Outcomes in Patients Undergoing Arthroscopic Shoulder Surgery After Middle-Size Rotator Cuff Muscle Tear
Recent systematic reviews, and meta-analyses concluded that rotator cuff and scapular strengthening exercises should be included in rehabilitation programs for patients with middle-size rotator cuff muscle tear. Superior translation of the humeral head is one of the factors adversely affecting this rehabilitation process. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.
Read the detailed description
Shoulder pain is one of the most common types of musculoskeletal pain syndroms in the general population as its prevalence has been estimated between 7% and 26% and its annual incidence between 0.9% and 2.5%. Rotator cuff tear is one of the most common causes of painful shoulders. Lack of coordination or weakness of scapulothoracic and scapulohumeral muscles is one of the main factors thought to lead to muscle tears in shoulder. More specifically, the inability of the scapular muscles to achieve superior rotation and posterior tilt, as well as the failure of rotator cuff muscles to counter the superior humeral head translation imposed by deltoid contraction can lead to impingement of the subacromial soft tissues while performing overhead dynamic tasks. This increases the rotator cuff tears' prevalance. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.
- Conditions
- Rotator Cuff Tears, Surgery
- Being tested
- Humeral Head Depressor Muscle Co-Activation Training- Experimental Group, Control Group
- Keywords
- rotator cuff, tear, rehabilitation
- Medical subject headings
- Rotator Cuff Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humeral Head Depressor Muscle Co-Activation Training- Experimental GroupOther
In addition to the conservative treatment, humeral head depressor muscle co-activation training will be applied for 14 weeks. Participants in the coactivation group will perform the glenohumeral exercises while recruiting the pectoralis major, latissimus dorsi, and teres major muscles. To achieve this, voluntary recruitment of the pectoralis major, latissimus dorsi, and teres major will be taught prior to the demonstration of the glenohumeral exercises using visual feedback provided by EMG Biofeedback. When recruitment is correctly executed (50% of the maximum voluntary contraction signal), it should be maintained while performing the glenohumeral exercises. This will be confirmed by visualizing EMG signals during the exercise training session. During each appointment with the therapist, participants will be evaluated on their capacity to achieve the exercises while performing co-activation.
Control GroupOther
The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.).
Individuals in the control group will use shoulder straps for 6 weeks after arthroscopic shoulder surgery. These patients will be referred to physiotherapy clinics 6th week. Patients between 6 and 20 weeks (a total of 14 weeks) will be admitted to the rehabilitation program according to the guideline mentioned above.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In addition to the conservative treatment of the control group, humeral head depressor muscle co-activation training will be applied for 14 weeks. Receives: Other: Humeral Head Depressor Muscle Co-Activation Training- Experimental Group |
| Control Group | Active comparator | The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.). Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (Pain)
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable. We use VAS to measure patient's perceived pain intensity during activity, at rest and at sleep during the last week preceding the assessment. MCIC for pain VAS is reported to be 2 points or 30%.
Measured: 14 weeks
Secondary outcomes (5)
The Constant-Murley Score
The Constant-Murley Score is the most widely used shoulder evaluating instrument in Europe despite its limitations. The 100-point scoring scale takes into account both subjective and objective measurements and is divided into four domains (pain: 15 points; activities of daily living: 20 points; range of motion: 40 points; strength: 25 points). Minimal clinically important difference (MCID) for Constant-Murley Score is reported to be between 10.4 and 17 points.
Measured: 14 weeks
Western Ontario Rotator Cuff Index (WORC)
WORC is a disease specific self-reported instrument for rotator cuff disease. It consists 21 visual analogue scale (VAS) items in five domains: physical symptoms (six items), sports/recreation (four items), work (four items), lifestyle (four items) and emotions (three items). All items respect quality of life (QoL) aspects that can particularly be influenced by rotator cuff injury. Each item has a possible score from 0 to 100 (100 mm VAS), and these scores are added to give a total score from 0 to 2100. A score of 0 implies no reduction in QoL, and a score of 2100 is the worst score possible. The data can be converted to a percent score by inverting the raw score and then converting it to a score out of 100 (2100 'patient WORC raw score'/21). The domains are based on the WHO definition of health. WORC is determined to have the highest ratings among all shoulder instruments. The minimally clinically important change (MCIC) for WORC is reported to be 275 points or 12.8%.
Measured: 14 weeks
DASH Score
The DASH questionnaire is a 30-item questionnaire that assesses upper extremity-related symptoms and measures functional status at the level of disability. The questionnaire consists of three sections: Symptoms; Sport and Music; and Work. The first section is composed of 30 items. The second and third sections are an optional module for Sport and Music, and four items for Work. Each item is scored with a 5-point scale: 1, no difficulty/symptoms; 2, mild difficulty/symptoms; 3, moderate difficulty/symptoms; 4, severe difficulty/symptoms; 5, extreme difficulty/symptoms (unable to do). The result of each module is summed and transformed to obtain the DASH score ranging, for each section, from 0 (best function) to 100 (severe disability).
Measured: 14 weeks
Oxford Shoulder Score
Oxford Shoulder Score (OSS), a 12-item scale rated on a five-point Likert scale from 0-4 (0=poor function, 4=good function). Daily pain and number of repetitions per exercise during home exercises were rated in the participants' diary.
Measured: 14 weeks
Range of Motion
A universal goniometer will be used for measuring of range of motion (flexion, extension, elevation, abduction, external rotation, and internal rotation).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start7 Jul 2020
- Primary completion20 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154592
- Sponsor's protocol ID
- 2019500
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryosa A, Kukkonen J, Bjornsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Boe B, Aarimaa V; ACCURATE study group. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019 May 19;9(5):e025022. doi: 10.1136/bmjopen-2018-025022.
PubMed 31110087Boudreau N, Gaudreault N, Roy JS, Bedard S, Balg F. The Addition of Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program for Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 Mar;49(3):126-135. doi: 10.2519/jospt.2019.8240. Epub 2018 Nov 30.
PubMed 30501388Overbeek CL, Kolk A, Nagels J, de Witte PB, van der Zwaal P, Visser CPJ, Fiocco M, Nelissen RGHH, de Groot JH. Increased co-contraction of arm adductors is associated with a favorable course in subacromial pain syndrome. J Shoulder Elbow Surg. 2018 Nov;27(11):1925-1931. doi: 10.1016/j.jse.2018.06.015. Epub 2018 Sep 19.
PubMed 30243903
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Humeral Head Depressor Muscle Co-Activation Training on Functional Outcomes in Patients Undergoing Arthroscopic Shoulder Surgery After Middle-Size Rotator Cuff Muscle Tear
- ClinicalTrials.gov ID
- NCT04154592
- Acronym / sponsor ID
- 2019500
- Conditions
- Rotator Cuff Tears, Surgery
- Keywords
- rotator cuff, tear, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 6 Nov 2019 (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.
Recent systematic reviews, and meta-analyses concluded that rotator cuff and scapular strengthening exercises should be included in rehabilitation programs for patients with middle-size rotator cuff muscle tear. Superior translation of the humeral head is one of the factors adversely affecting this rehabilitation process. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.
Detailed description
Shoulder pain is one of the most common types of musculoskeletal pain syndroms in the general population as its prevalence has been estimated between 7% and 26% and its annual incidence between 0.9% and 2.5%. Rotator cuff tear is one of the most common causes of painful shoulders. Lack of coordination or weakness of scapulothoracic and scapulohumeral muscles is one of the main factors thought to lead to muscle tears in shoulder. More specifically, the inability of the scapular muscles to achieve superior rotation and posterior tilt, as well as the failure of rotator cuff muscles to counter the superior humeral head translation imposed by deltoid contraction can lead to impingement of the subacromial soft tissues while performing overhead dynamic tasks. This increases the rotator cuff tears' prevalance. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Humeral Head Depressor Muscle Co-Activation Training- Experimental GroupIn addition to the conservative treatment of the control group, humeral head depressor muscle co-activation training will be applied for 14 weeks. |
| Control Group | Active comparator | Other: Control GroupThe American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the presence of middle-sized (1-3 cm) rotator cuff muscle rupture,
- undergoing arthroscopic repair surgery,
- volunteering to participate in the study.
Key exclusion criteria (6 listed)
- presence of diabetic mellitus,
- stage 3 and above according to Goutallier classification,
- presence of any contraindication for mobilization (hypermobility, trauma, inflammation, etc.),
- visual, verbal, cognitive defects (aphasia, unilateral neglect, etc.),
- the presence of any neurological problem,
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 |
|---|---|---|
| Humeral Head Depressor Muscle Co-Activation Training- Experimental GroupIn addition to the conservative treatment, humeral head depressor muscle co-activation training will be applied for 14 weeks. Participants in the coactivation group will perform the glenohumeral exercises while recruiting the pectoralis major, latissimus dorsi, and teres major muscles. To achieve this, voluntary recruitment of the pectoralis major, latissimus dorsi, and teres major will be taught prior to the demonstration of the glenohumeral exercises using visual feedback provided by EMG Biofeedback. When recruitment is correctly executed (50% of the maximum voluntary contraction signal), it should be maintained while performing the glenohumeral exercises. This will be confirmed by visualizing EMG signals during the exercise training session. During each appointment with the therapist, participants will be evaluated on their capacity to achieve the exercises while performing co-activation. | Other | Experimental Group |
| Control GroupThe American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.). Individuals in the control group will use shoulder straps for 6 weeks after arthroscopic shoulder surgery. These patients will be referred to physiotherapy clinics 6th week. Patients between 6 and 20 weeks (a total of 14 weeks) will be admitted to the rehabilitation program according to the guideline mentioned above. | Other | Control Group |
Primary outcome
Visual Analogue Scale (Pain)
Time frame: 14 weeks
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable. We use VAS to measure patient's perceived pain intensity during activity, at rest and at sleep during the last week preceding the assessment. MCIC for pain VAS is reported to be 2 points or 30%.
5 secondary outcomes
The Constant-Murley Score
Time frame: 14 weeks
Western Ontario Rotator Cuff Index (WORC)
Time frame: 14 weeks
DASH Score
Time frame: 14 weeks
Oxford Shoulder Score
Time frame: 14 weeks
Range of Motion
Time frame: 14 weeks
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 4 Feb 2021.
- Background: PubMed 31110087Ryosa A, Kukkonen J, Bjornsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Boe B, Aarimaa V; ACCURATE study group. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019 May 19;9(5):e025022. doi: 10.1136/bmjopen-2018-025022.
- Background: PubMed 30501388Boudreau N, Gaudreault N, Roy JS, Bedard S, Balg F. The Addition of Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program for Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 Mar;49(3):126-135. doi: 10.2519/jospt.2019.8240. Epub 2018 Nov 30.
- Background: PubMed 30243903Overbeek CL, Kolk A, Nagels J, de Witte PB, van der Zwaal P, Visser CPJ, Fiocco M, Nelissen RGHH, de Groot JH. Increased co-contraction of arm adductors is associated with a favorable course in subacromial pain syndrome. J Shoulder Elbow Surg. 2018 Nov;27(11):1925-1931. doi: 10.1016/j.jse.2018.06.015. Epub 2018 Sep 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humeral Head Depressor Muscle Co-Activation Training- Experimental Group in people with Rotator Cuff Tears and Surgery, run by Hacettepe 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 6 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 4 Feb 2021. 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?
Visual Analogue Scale (Pain) (time frame: 14 weeks). 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 NCT04154592, which also lists 3 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 4 Feb 2021.