Adhesive CapsulitisNCT05797311
The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC
A study testing Proprioceptive Neuromuscular Facilitation (PNF) and Shoulder Stabilization Exercises in people with Adhesive Capsulitis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Proprioceptive Neuromuscular Facilitation (PNF) and Shoulder Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Jan 2024
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging
- Shoulder pain persisting for at least 3 months
- VAS pain score equal to or greater than 5/10
- Patients who agreed to participate in the study
Who cannot join
- - Receiving physical therapy or manual therapy on the same shoulder within 1 year
- Having mental and cognitive problems,
- Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason
- Neurological disorders that affect shoulder function during daily activities
- Pain or discomfort in the cervical spine, elbow, wrist, or hand
- Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment
Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release).
Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.
Read the detailed description
There are studies on the application of PNF techniques in proprioceptive neuromuscular facilitation (PNF), sports injuries, orthopedics, cardiorespiratory and neurological conditions developed by Knott and Kabat. Recently, the application of these techniques in orthopedic conditions has been developing. However, studies have been conducted to find out the effect of PNF therapy on Adhesive Capsulitis, but there is conflicting evidence between them. Although some studies have suggested PNF, determining which technique is better in the treatment of AC remains controversial and needs to be answered. Therefore, in our study, it was aimed to compare the effects and advantages of proprioceptive neuromuscular exercises and shoulder stabilization exercises applied in the treatment of patients with Adhesive capsulitis and to evaluate the acute effects of these exercises on shoulder movements.
- Conditions
- Adhesive Capsulitis
- Being tested
- Proprioceptive Neuromuscular Facilitation (PNF), Shoulder Stabilization Exercises
- Keywords
- adhesive Capsulitis, pain, Proprioceptive Neuromuscular Facilitation, Shoulder Stabilization Exercises
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation (PNF)Other
Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities.
Shoulder Stabilization ExercisesOther
Scapular stabilization exercise and stabilization exercise for the shoulder joints
| Study group | Role | What they receive |
|---|---|---|
| PNF Group | Experimental | After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions).
1. PNF contract-relax to subscapularis and internal rotators (7 Sec of contraction and 15 Sec of relaxation in external rotation, 5 repetitions) Followed by facilitation of D2 Flexion patterns for 5 repetitions.
2. PNF all scapular patterns with Rhythmic initiation and repeated contractions Technique . Receives: Other: Proprioceptive Neuromuscular Facilitation (PNF) |
| Stabilization Group | Other | After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions).
1. scapular stabilization exercises
2. stabilization exercise for the shoulder joints.
In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set. Receives: Other: Shoulder Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Evaluation
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.
Measured: Change from baseline to week 3
Secondary outcomes (4)
Manual Muscle Testing
During the testing of muscle strength without using any device ("manual muscle testing"), the evaluation system (Medical Research Council (MRC)) scale, which is widely used all over the world, is used. It is the evaluation of motion in the context of gravity.
Measured: Change from baseline to week 3
Joint Range of Motion
A Goniometer is the most common tool for measuring range of motion of the joints of the body. It uses a stationary arm, fulcrum, and movement arm to measure joint angles from the axis of the joint. Making a ROM measurement by using a goniometer requires training for reliable results. See the goniometry collection of pages for instructions on how to correctly (reliably and accurately) place the goniometer when measuring range of motion.
Measured: Change from baseline to week 3
DASH (Arm, Shoulder and Hand Problems Questionnaire)
The DASH questionnaire consists of 3 parts. The first part consists of 30 questions. 21 questions evaluate the degree of difficulty of the patient in daily activities, 5 questions evaluate the symptomatic features of pain, and 4 questions evaluate social function, self-confidence and sleep.
Measured: Change from baseline to week 3
Short Form 12 (SF-12)
SF-12, a measure of Health-Related Quality of Life, can be used in age, disease and treatment groups. It is a shortened version of the SF-36 and contains 12 questions, each with two to five answer options. The patient is told to choose the option that best suits him/her. The SF-12 covers eight dimensions: general health, physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. A physical and mental health score, each ranging from 0 to 100, can be calculated using scoring algorithms. Scores are calibrated to a mean score of 50, or the norm, with lower scores representing worse and higher scores representing better Health-Related Quality of Life.
Measured: Change from baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies 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 trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- safiye gul abat, PT, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797311
- Sponsor's protocol ID
- UskudarUniversity
- Status last verified
- Feb 2024
- First submitted
- 10 Mar 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
PubMed 31475043Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
PubMed 29992159Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
PubMed 33326025Barbosa F, Swamy G, Salem H, Creswell T, Espag M, Tambe A, Clark D. Chronic adhesive capsulitis (Frozen shoulder): Comparative outcomes of treatment in patients with diabetes and obesity. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):265-268. doi: 10.1016/j.jcot.2018.02.015. Epub 2018 Feb 25.
PubMed 30828190Kraal T, Visser C, Sierevelt I, Beimers L. How to treat a frozen shoulder? A survey among shoulder specialists in the Netherlands and Belgium. Acta Orthop Belg. 2016 Mar;82(1):78-84.
PubMed 26984658Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
PubMed 20110457Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.
PubMed 31789299Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28.
PubMed 27190456Park SI, Choi YK, Lee JH, Kim YM. Effects of shoulder stabilization exercise on pain and functional recovery of shoulder impingement syndrome patients. J Phys Ther Sci. 2013 Nov;25(11):1359-62. doi: 10.1589/jpts.25.1359. Epub 2013 Dec 11.
PubMed 24396188Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
PubMed 29489251
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
- The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment
- ClinicalTrials.gov ID
- NCT05797311
- Acronym / sponsor ID
- UskudarUniversity
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive Capsulitis, pain, Proprioceptive Neuromuscular Facilitation, Shoulder Stabilization Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 4 Apr 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.
Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release).
Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.
Detailed description
There are studies on the application of PNF techniques in proprioceptive neuromuscular facilitation (PNF), sports injuries, orthopedics, cardiorespiratory and neurological conditions developed by Knott and Kabat. Recently, the application of these techniques in orthopedic conditions has been developing. However, studies have been conducted to find out the effect of PNF therapy on Adhesive Capsulitis, but there is conflicting evidence between them. Although some studies have suggested PNF, determining which technique is better in the treatment of AC remains controversial and needs to be answered. Therefore, in our study, it was aimed to compare the effects and advantages of proprioceptive neuromuscular exercises and shoulder stabilization exercises applied in the treatment of patients with Adhesive capsulitis and to evaluate the acute effects of these exercises on shoulder movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PNF Group | Experimental | Other: Proprioceptive Neuromuscular Facilitation (PNF)After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions). 1. PNF contract-relax to subscapularis and internal rotators (7 Sec of contraction and 15 Sec of relaxation in external rotation, 5 repetitions) Followed by facilitation of D2 Flexion patterns for 5 repetitions. 2. PNF all scapular patterns with Rhythmic initiation and repeated contractions Technique . |
| Stabilization Group | Other | Other: Shoulder Stabilization ExercisesAfter classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions). 1. scapular stabilization exercises 2. stabilization exercise for the shoulder joints. In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging
- Shoulder pain persisting for at least 3 months
- VAS pain score equal to or greater than 5/10
- Patients who agreed to participate in the study
Key exclusion criteria (6 listed)
- - Receiving physical therapy or manual therapy on the same shoulder within 1 year
- Having mental and cognitive problems,
- Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason
- Neurological disorders that affect shoulder function during daily activities
- Pain or discomfort in the cervical spine, elbow, wrist, or hand
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 |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation (PNF)Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities. | Other | PNF Group |
| Shoulder Stabilization ExercisesScapular stabilization exercise and stabilization exercise for the shoulder joints | Other | Stabilization Group |
Primary outcome
Visual Analog Scale (VAS) Evaluation
Time frame: Change from baseline to week 3
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.
4 secondary outcomes
Manual Muscle Testing
Time frame: Change from baseline to week 3
Joint Range of Motion
Time frame: Change from baseline to week 3
DASH (Arm, Shoulder and Hand Problems Questionnaire)
Time frame: Change from baseline to week 3
Short Form 12 (SF-12)
Time frame: Change from baseline to week 3
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 31475043Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
- Background: PubMed 29992159Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
- Background: PubMed 33326025Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
- Background: PubMed 30828190Barbosa F, Swamy G, Salem H, Creswell T, Espag M, Tambe A, Clark D. Chronic adhesive capsulitis (Frozen shoulder): Comparative outcomes of treatment in patients with diabetes and obesity. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):265-268. doi: 10.1016/j.jcot.2018.02.015. Epub 2018 Feb 25.
- Background: PubMed 26984658Kraal T, Visser C, Sierevelt I, Beimers L. How to treat a frozen shoulder? A survey among shoulder specialists in the Netherlands and Belgium. Acta Orthop Belg. 2016 Mar;82(1):78-84.
- Background: PubMed 20110457Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
- Background: PubMed 31789299Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.
- Background: PubMed 27190456Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28.
- Background: PubMed 24396188Park SI, Choi YK, Lee JH, Kim YM. Effects of shoulder stabilization exercise on pain and functional recovery of shoulder impingement syndrome patients. J Phys Ther Sci. 2013 Nov;25(11):1359-62. doi: 10.1589/jpts.25.1359. Epub 2013 Dec 11.
- Background: PubMed 29489251Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
- 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.
safiye gul abat, PT principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation (PNF) and Shoulder Stabilization Exercises in people with Adhesive Capsulitis, run by Uskudar 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 4 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 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?
Visual Analog Scale (VAS) Evaluation (time frame: Change from baseline to week 3). 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 NCT05797311, which also lists 10 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.