Subacromial ImpingementNCT06106048
Comparative Effects of Conscious Abdominal Contraction and Closed Kinetic Chain Exercises
A study testing Closed kinetic chain exercises and Abdominal contraction exercises in people with Subacromial Impingement, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
Subacromial pain syndrome is a general term used to describe pain which originates from the shoulder and can spread towards the neck or down the arm. It's the most common reason for shoulder pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Subacromial Impingement
- What is being tested?
- Closed kinetic chain exercises and Abdominal contraction exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Aug 2023to 30 Apr 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male Badminton players
- Age 20 to 40 years
- Unilateral shoulder pain
- Pain with overhead activities
- Positive Hawkins Kennedy test
- Positive painful arc(60-120 degrees)
Show all 9Show fewer
- Positive Neer impingement test
- Positive external rotation test
- Numeric pain Rating Scale NPRS value(3-7)
Who cannot join
- Adhesive capsulitis
- Know shoulder instability
- Neck pain
- Radiating pain from shoulder to hand
- Receiving any intervention for shoulder injury.
- Previous history of 6 month shoulder trauma.
- Previous history of shoulder surgery.
- Taking any critical care medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Conscious Abdominal Contraction and Closed Kinetic Chain Exercises on the Activation of Periscapular Muscles in Badminton Players With Subacromial Pain Syndrome
Subacromial pain syndrome is a general term used to describe pain which originates from the shoulder and can spread towards the neck or down the arm. It's the most common reason for shoulder pain. The aim of study was to compare the effects of conscious abdominal contraction and closed kinetic chain exercises on the activation of peri-scapular muscles in badminton players with sub-acromial pain syndrome.
Read the detailed description
A Randomized Clinical Trial was conducted at Sir Syed Sports Complex Sargodha, through convenience sampling technique on 52 patients which was allocated using random sampling through computerized generated number into Group A and Group B. Group A was treated with closed kinetic chain exercises. Group B was treated with abdominal contraction exercises for periscapular activation. These exercises were done in 3 sets with 10 repetitions. There was 3 sessions per week. Baseline measurement was taken on 1st day of evaluation and post treatment will be taken on 4th week. Data was analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test was used within a group or between two groups.
- Conditions
- Subacromial Impingement
- Being tested
- Closed kinetic chain exercises, Abdominal contraction exercises
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed kinetic chain exercisesOther
Group A was treated with closed kinetic chain exercises. Group A: Group A was treated with closed kinetic chain exercises. Closed kinetic chain exercises enhance the proprioception by coordinating the mechanical receptors as well as the strength of the external shoulder rotator muscles, reduce the pain and improve the shoulder.
Closed kinetic chain exercises include:
- Push up
- Scapular push up
- Scapular dip
- Crab walk
Common Treatment:
Cryotherapy 10 minutes 2 times per day. Ultrasonography 1Mhz frequency, 0.4 watt/cm for 10 minutes. Transcutaneous electrical stimulation (TENS) 10 minutes, modulation mode, frequency 280, wavelength 80.
Cross arm stretching 5 times 30 sec hold. Shoulder isometric exercises 10 repetitions 3 sets for 3 times per week.
Abdominal contraction exercisesOther
Group B was treated with abdominal contraction exercises for periscapular activation that includes: Wall slide, knee pushup, external rotation kneeling, Full can and External rotation with elevation and isometric low row.
Common Treatment:
Cryotherapy 10 minutes 2 times per day. Ultrasonography 1Mhz frequency, 0.4 watt/cm for 10 minutes. Transcutaneous electrical stimulation (TENS) 10 minutes, modulation mode, frequency 280,wavelength 80.
Cross arm stretching 5 times 30 sec hold. Shoulder isometric exercises 10 repetitions 3 sets for 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A was treated with closed kinetic chain exercises Receives: Other: Closed kinetic chain exercises |
| Group B | Experimental | Group B was treated with abdominal contraction exercises for periscapular activation Receives: Other: Abdominal contraction exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Patient level of pain will be assessed using this scale. In a Numerical Rating Scale (NRS), this scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" patients are asked to circle the number between 0 and 10, that fits best to their pain intensity.
NRS scores ≤ 5 correspond to mild, scores of 6-7 to moderate and scores ≥8 to severe pain in terms of pain-related interference with functioning.
Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible. The NPRS is a widely used subjective pain measure that has good test-retest reliability (r=. 79-. 96) and validity of NPRS range from 0.86 to 0.95.
Measured: upto 4-week
SPADI
The Shoulder Pain and Disability Index (SPADI) consists of 13 items that have two main domains; in which subscale of 5-item that measures the pain and subscale of 8- item measures disability. The reliability of SPADI ranged from 0.90 to 0.94 and the validity ranged from 0.87 to 0.89.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Measured: upto 4-week
Universal Goniometer
A goniometer will be used in the study to measure shoulder flexion, internal rotation and external rotation.
Goniometer is an instrument that measures the available range of motion at a joint. To .measure the range of motion physical therapists most commonly use a goniometer. Therapist can use a goniometer to assess what the range of motion is at the initial assessment. The validity of UG (r=0.84 to 0.93) and high intra-rater reliability of goniometer on repeated measures of shoulder range of motions (ICC=0.98-0.99).
Measured: upto 4-week
Dynamometer
A dynamometer will be used in study to measure the strength of serratus anterior muscle, latissimus dorsi muscle, upper and lower trapezius muscles It is is a device that can measure force. The hand-held dynamometer is a small device that fits in the examiner's hand and is placed at precise locations on a subject's limb in an effort to assess the force generated by various muscles or groups of muscles. Inter-tester and intra-tester reliability of digital dynamometer were excellent for all movements (ICC ≥ 0.855) and validity is > 0.913.
Measured: upto 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start23 Aug 2023
- Primary completion23 Mar 2024
- Study completion30 Apr 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 Subacromial ImpingementStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Imran Ghafoor, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106048
- Sponsor's protocol ID
- REC/RCRS &AHS/23/0460
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park SW, Chen YT, Thompson L, Kjoenoe A, Juul-Kristensen B, Cavalheri V, McKenna L. No relationship between the acromiohumeral distance and pain in adults with subacromial pain syndrome: a systematic review and meta-analysis. Sci Rep. 2020 Nov 26;10(1):20611. doi: 10.1038/s41598-020-76704-z.
PubMed 33244115Saito H, Harrold ME, Cavalheri V, McKenna L. Scapular focused interventions to improve shoulder pain and function in adults with subacromial pain: A systematic review and meta-analysis. Physiother Theory Pract. 2018 Sep;34(9):653-670. doi: 10.1080/09593985.2018.1423656. Epub 2018 Jan 19.
PubMed 29351510Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
PubMed 31726927Pogetti LS, Nakagawa TH, Contecote GP, Camargo PR. Core stability, shoulder peak torque and function in throwing athletes with and without shoulder pain. Phys Ther Sport. 2018 Nov;34:36-42. doi: 10.1016/j.ptsp.2018.08.008. Epub 2018 Aug 17.
PubMed 30145541Overbeek CL, Kolk A, de Groot JH, Visser CPJ, van der Zwaal P, Jens A, Nagels J, Nelissen RGHH. Altered Cocontraction Patterns of Humeral Head Depressors in Patients with Subacromial Pain Syndrome: A Cross-sectional Electromyography Analysis. Clin Orthop Relat Res. 2019 Aug;477(8):1862-1868. doi: 10.1097/CORR.0000000000000745.
PubMed 31107319de Oliveira Scatolin R, Hotta GH, Cools AM, Custodio GAP, de Oliveira AS. Effect of conscious abdominal contraction on the activation of periscapular muscles in individuals with subacromial pain syndrome. Clin Biomech (Bristol). 2021 Apr;84:105349. doi: 10.1016/j.clinbiomech.2021.105349. Epub 2021 Apr 2.
PubMed 33848705Silva YA, Novaes WA, Dos Passos MHP, Nascimento VYS, Cavalcante BR, Pitangui ACR, De Araujo RC. Reliability of the Closed Kinetic Chain Upper Extremity Stability Test in young adults. Phys Ther Sport. 2019 Jul;38:17-22. doi: 10.1016/j.ptsp.2019.04.004. Epub 2019 Apr 9.
PubMed 31035171Cappato de Araujo R, Andrade da Silva H, Pereira Dos Passos MH, Alves de Oliveira VM, Rodarti Pitangui AC. Use of unstable exercises in periscapular muscle activity: A systematic review and meta-analysis of electromyographic studies. J Bodyw Mov Ther. 2021 Apr;26:318-328. doi: 10.1016/j.jbmt.2020.12.010. Epub 2020 Dec 8.
PubMed 33992265Scott R, Yang HS, James CR, Sawyer SF, Sizer PS Jr. Volitional Preemptive Abdominal Contraction and Upper Extremity Muscle Latencies During D1 Flexion and Scaption Shoulder Exercises. J Athl Train. 2018 Dec;53(12):1181-1189. doi: 10.4085/1062-6050-255-17. Epub 2018 Dec 13.
PubMed 30543446Werin M, Maenhout A, Smet S, Van Holder L, Cools A. Muscle recruitment during plyometric exercises in overhead athletes with and without shoulder pain. Phys Ther Sport. 2020 May;43:19-26. doi: 10.1016/j.ptsp.2020.01.015. Epub 2020 Feb 1.
PubMed 32058922
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Conscious Abdominal Contraction and Closed Kinetic Chain Exercises on the Activation of Periscapular Muscles in Badminton Players With Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06106048
- Acronym / sponsor ID
- REC/RCRS &AHS/23/0460
- Conditions
- Subacromial Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 23 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 30 Oct 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.
Subacromial pain syndrome is a general term used to describe pain which originates from the shoulder and can spread towards the neck or down the arm. It's the most common reason for shoulder pain. The aim of study was to compare the effects of conscious abdominal contraction and closed kinetic chain exercises on the activation of peri-scapular muscles in badminton players with sub-acromial pain syndrome.
Detailed description
A Randomized Clinical Trial was conducted at Sir Syed Sports Complex Sargodha, through convenience sampling technique on 52 patients which was allocated using random sampling through computerized generated number into Group A and Group B. Group A was treated with closed kinetic chain exercises. Group B was treated with abdominal contraction exercises for periscapular activation. These exercises were done in 3 sets with 10 repetitions. There was 3 sessions per week. Baseline measurement was taken on 1st day of evaluation and post treatment will be taken on 4th week. Data was analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test was used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Closed kinetic chain exercisesGroup A was treated with closed kinetic chain exercises |
| Group B | Experimental | Other: Abdominal contraction exercisesGroup B was treated with abdominal contraction exercises for periscapular activation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male Badminton players
- Age 20 to 40 years
- Unilateral shoulder pain
- Pain with overhead activities
- Positive Hawkins Kennedy test
Key exclusion criteria (8 listed)
- Adhesive capsulitis
- Know shoulder instability
- Neck pain
- Radiating pain from shoulder to hand
- Receiving any intervention for shoulder injury.
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 |
|---|---|---|
| Closed kinetic chain exercisesGroup A was treated with closed kinetic chain exercises. Group A: Group A was treated with closed kinetic chain exercises. Closed kinetic chain exercises enhance the proprioception by coordinating the mechanical receptors as well as the strength of the external shoulder rotator muscles, reduce the pain and improve the shoulder. Closed kinetic chain exercises include: * Push up * Scapular push up * Scapular dip * Crab walk Common Treatment: Cryotherapy 10 minutes 2 times per day. Ultrasonography 1Mhz frequency, 0.4 watt/cm for 10 minutes. Transcutaneous electrical stimulation (TENS) 10 minutes, modulation mode, frequency 280, wavelength 80. Cross arm stretching 5 times 30 sec hold. Shoulder isometric exercises 10 repetitions 3 sets for 3 times per week. | Other | Group A |
| Abdominal contraction exercisesGroup B was treated with abdominal contraction exercises for periscapular activation that includes: Wall slide, knee pushup, external rotation kneeling, Full can and External rotation with elevation and isometric low row. Common Treatment: Cryotherapy 10 minutes 2 times per day. Ultrasonography 1Mhz frequency, 0.4 watt/cm for 10 minutes. Transcutaneous electrical stimulation (TENS) 10 minutes, modulation mode, frequency 280,wavelength 80. Cross arm stretching 5 times 30 sec hold. Shoulder isometric exercises 10 repetitions 3 sets for 3 times per week. | Other | Group B |
Primary outcome
NPRS
Time frame: upto 4-week
Patient level of pain will be assessed using this scale. In a Numerical Rating Scale (NRS), this scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. NRS scores ≤ 5 correspond to mild, scores of 6-7 to moderate and scores ≥8 to severe pain in terms of pain-related interference with functioning. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible. The NPRS is a widely used subjective pain measure that has good test-retest reliability (r=. 79-. 96) and validity of NPRS range from 0.86 to 0.95.
SPADI
Time frame: upto 4-week
The Shoulder Pain and Disability Index (SPADI) consists of 13 items that have two main domains; in which subscale of 5-item that measures the pain and subscale of 8- item measures disability. The reliability of SPADI ranged from 0.90 to 0.94 and the validity ranged from 0.87 to 0.89. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Universal Goniometer
Time frame: upto 4-week
A goniometer will be used in the study to measure shoulder flexion, internal rotation and external rotation. Goniometer is an instrument that measures the available range of motion at a joint. To .measure the range of motion physical therapists most commonly use a goniometer. Therapist can use a goniometer to assess what the range of motion is at the initial assessment. The validity of UG (r=0.84 to 0.93) and high intra-rater reliability of goniometer on repeated measures of shoulder range of motions (ICC=0.98-0.99).
Dynamometer
Time frame: upto 4-week
A dynamometer will be used in study to measure the strength of serratus anterior muscle, latissimus dorsi muscle, upper and lower trapezius muscles It is is a device that can measure force. The hand-held dynamometer is a small device that fits in the examiner's hand and is placed at precise locations on a subject's limb in an effort to assess the force generated by various muscles or groups of muscles. Inter-tester and intra-tester reliability of digital dynamometer were excellent for all movements (ICC ≥ 0.855) and validity is > 0.913.
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 2 May 2024.
- Background: PubMed 33244115Park SW, Chen YT, Thompson L, Kjoenoe A, Juul-Kristensen B, Cavalheri V, McKenna L. No relationship between the acromiohumeral distance and pain in adults with subacromial pain syndrome: a systematic review and meta-analysis. Sci Rep. 2020 Nov 26;10(1):20611. doi: 10.1038/s41598-020-76704-z.
- Background: PubMed 29351510Saito H, Harrold ME, Cavalheri V, McKenna L. Scapular focused interventions to improve shoulder pain and function in adults with subacromial pain: A systematic review and meta-analysis. Physiother Theory Pract. 2018 Sep;34(9):653-670. doi: 10.1080/09593985.2018.1423656. Epub 2018 Jan 19.
- Background: PubMed 31726927Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
- Background: PubMed 30145541Pogetti LS, Nakagawa TH, Contecote GP, Camargo PR. Core stability, shoulder peak torque and function in throwing athletes with and without shoulder pain. Phys Ther Sport. 2018 Nov;34:36-42. doi: 10.1016/j.ptsp.2018.08.008. Epub 2018 Aug 17.
- Background: PubMed 31107319Overbeek CL, Kolk A, de Groot JH, Visser CPJ, van der Zwaal P, Jens A, Nagels J, Nelissen RGHH. Altered Cocontraction Patterns of Humeral Head Depressors in Patients with Subacromial Pain Syndrome: A Cross-sectional Electromyography Analysis. Clin Orthop Relat Res. 2019 Aug;477(8):1862-1868. doi: 10.1097/CORR.0000000000000745.
- Background: PubMed 33848705de Oliveira Scatolin R, Hotta GH, Cools AM, Custodio GAP, de Oliveira AS. Effect of conscious abdominal contraction on the activation of periscapular muscles in individuals with subacromial pain syndrome. Clin Biomech (Bristol). 2021 Apr;84:105349. doi: 10.1016/j.clinbiomech.2021.105349. Epub 2021 Apr 2.
- Background: PubMed 31035171Silva YA, Novaes WA, Dos Passos MHP, Nascimento VYS, Cavalcante BR, Pitangui ACR, De Araujo RC. Reliability of the Closed Kinetic Chain Upper Extremity Stability Test in young adults. Phys Ther Sport. 2019 Jul;38:17-22. doi: 10.1016/j.ptsp.2019.04.004. Epub 2019 Apr 9.
- Background: PubMed 33992265Cappato de Araujo R, Andrade da Silva H, Pereira Dos Passos MH, Alves de Oliveira VM, Rodarti Pitangui AC. Use of unstable exercises in periscapular muscle activity: A systematic review and meta-analysis of electromyographic studies. J Bodyw Mov Ther. 2021 Apr;26:318-328. doi: 10.1016/j.jbmt.2020.12.010. Epub 2020 Dec 8.
- Background: PubMed 30543446Scott R, Yang HS, James CR, Sawyer SF, Sizer PS Jr. Volitional Preemptive Abdominal Contraction and Upper Extremity Muscle Latencies During D1 Flexion and Scaption Shoulder Exercises. J Athl Train. 2018 Dec;53(12):1181-1189. doi: 10.4085/1062-6050-255-17. Epub 2018 Dec 13.
- Background: PubMed 32058922Werin M, Maenhout A, Smet S, Van Holder L, Cools A. Muscle recruitment during plyometric exercises in overhead athletes with and without shoulder pain. Phys Ther Sport. 2020 May;43:19-26. doi: 10.1016/j.ptsp.2020.01.015. Epub 2020 Feb 1.
- 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.
Dr. Imran Ghafoor principal investigator
Riphah International 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 Closed kinetic chain exercises and Abdominal contraction exercises in people with Subacromial Impingement, run by Sehat Medical Complex at 1 site in Pakistan.
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 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 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 Pakistan. 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?
NPRS (time frame: upto 4-week). The study lists 4 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 NCT06106048, 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 2 May 2024.