Subacromial ImpingementNCT03735485

Comparison of the Proprioceptive Neuromuscular Facilitation and Mobilization In Subacromial Impingement Syndrome

A study testing Conventional Physiotherapy, Shoulder Mobilization and Proprioceptive Neuromuscular Facilitation in people with Subacromial Impingement and Subacromial Impingement Syndrome, run by Sevgi Medical Center at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Subacromial Impingement, Subacromial Impingement Syndrome
What is being tested?: Conventional Physiotherapy, Shoulder Mobilization and Proprioceptive Neuromuscular Facilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Mar 2017to 10 Jan 2018
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 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged between 25-65 years old,
Having the diagnosis of Subacromial Impingement Syndrome (SIS),
Having shoulder pain at least for four weeks

Who cannot join

Having a neuromuscular disease,
Pregnancy,
History of cancer,
Unstable angina,
Having pulmonary and/or vascular problems,
History of surgery at neck, shoulder, elbow or/and hand,

Show all 13Show fewer

Having communication problems
Having systemic anti-inflammatory joint diseases
Being contraindicated for electrical stimulation and/or exercise
Having cervical disc herniation or radiculopathy
History of physiotherapy on the same shoulder due to SIS,
A history of corticosteroid injection in the last three months,
Any orthopedic, rheumatologic, or congenital condition that effects the targeted shoulder

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Sevgi Medical Center
Istanbul, Arnavutkoy, 34275

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises and Shoulder Mobilization Patients With Subacromial Impingement Syndrome: A Randomised Clinical Trial

Read the detailed description

Aim of the study was to compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercises and Shoulder Mobilization (SM) on pain, range of motion (ROM), functionality, and muscle strength in patients with Subacromial Impingement Syndrome (SIS). Forty-four patients were divided into three groups as Group I: Conventional physiotherapy receiving group (control group; n=14), Group II: Conventional physiotherapy + PNF exercises receiving group (PNF group; n=15), and Group III: conventional physiotherapy + SM receiving group (SM group; n=15). Pain, ROM, muscle strength, and functionality were evaluated by using visual analog scale (VAS), goniometer, push-pull dynamometer, Constant-Murley score and The Disabilities of the Arm, Shoulder and Hand (DASH) Score respectively. Patients received 20 sessions in total under supervision of a physiotherapist. Patients were evaluated at baseline, at week two, at week four, and at week sixteen.

Conditions: Subacromial Impingement, Subacromial Impingement Syndrome
Being tested: Conventional Physiotherapy, Shoulder Mobilization, Proprioceptive Neuromuscular Facilitation
Keywords: proprioceptive neuromuscular facilitation, functionality, mobilization, pnf
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.

Conventional PhysiotherapyOther
The conventional physiotherapy program consisted of electrotherapy and exercise approaches. The electrotherapy program consisted of infrared (for 15 minutes, from 70 cm distance), conventional Transcutaneous Electrical Nerve Stimulation (TENS) in an encircled region (for 20 minutes; with 4 electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound (for 3 minutes; 1 megahertz (MHz), power: 1,5 W/cm²).
A physiotherapist supervised exercise program was performed following the electrotherapy program. Elastic resistive exercises were added at the week three. While, the first set of wand exercises and elastic resistive exercises was performed under supervision, two sets of the showed exercises were given as the home exercise program.
Shoulder MobilizationOther
In shoulder mobilization technique while the shoulder joint was placed in the traction, anterior, posterior, and inferior gliding and circumduction were applied to the humerus for 2-3 minutes. All mobilization applications were performed in painless range of motion (ROM) limits. The degree of traction and gliding were increased as the relaxing obtained in the tissues.
Proprioceptive Neuromuscular FacilitationOther
In the Proprioceptive Neuromuscular Facilitation (PNF) program participants received PNF exercises with contract-relax technique, in the patterns of "flexion-abduction-external rotation", "extension-adduction-internal rotation", "flexion-adduction-external rotation" and "extension-abduction-internal rotation" along with the verbal and manual facilitation of the physiotherapist.

Study groups in NCT03735485
Study group	Role	What they receive
Group I	Experimental	The control group. Participants in this group received only conventional physiotherapy. Number of the participants were 14. Receives: Other: Conventional Physiotherapy
Group II	Experimental	The shoulder mobilization group. Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques. Number of the participants were 15. Receives: Other: Conventional Physiotherapy; Other: Shoulder Mobilization
Group III	Experimental	The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises. Number of the participants were 15. Receives: Other: Conventional Physiotherapy; Other: Proprioceptive Neuromuscular Facilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Shoulder pain: VAS
Pain was defined with Visual Analog Scale (VAS). A 10-cm long horizontal visual analog scale (VAS) with marks 0 point (no pain) and 10 point (unbearable pain) was used for evaluating the pain severity. The patients were asked to mark the representing point of their pain levels. The values were recorded in cm. The pain severity was asked in three occasions as: at resting (VASr), during activity (VASa) and during night (VASn).
Measured: Change from baseline pain scale of shoulder at week 2, 4 and 16.
Disability of the shoulder
The Disabilities of the Arm, Shoulder and Hand (DASH) Score was used to evaluate the upper extremity physical function. DASH includes two modules as disability / symptom section and work section. The scores are ranged between 0-100. Higher scores indicate lower functionality.
Measured: Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) Score at week 2, 4 and 16.
Function of the shoulder
In addition to DASH, the Constant-Murley score was used to evaluate the functionality of the shoulder. Constant-Murley score is a 100-point scoring system and consisted of four sub-scores as pain (15 points), daily living activities (20 points), active range of motion (40 points), and muscle strength (25 points).
Measured: Change from baseline Constant-Murley score at week 2, 4 and 16.
Range of motion
The active range of motion was assessed by using a universal goniometer.
Measured: Change from baseline active range of motion at week 2, 4 and 16.
Muscle Strength
The muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation were determined by using Baseline Push-Pull (New York, USA) dynamometer. The dynamometer was placed in a 90 degrees angle on the location and the patient was asked to contract in maximum for two seconds and then maintain this position for five seconds. Two assessments were performed, and average values were recorded. Pain was avoided during the measurements.
Measured: Change from baseline muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation at week 2, 4 and 16.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 201710 Jan 2018

First posted8 Nov 2018
Study start3 Mar 2017
Primary completion2 Oct 2017
Study completion10 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)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: Factorial
Model description: There were three study groups: 1. The control group: Participants in this group received only conventional physiotherapy treatment. 2. The shoulder mobilization group: Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques as treatment. The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises as treatment.
Masking: Single blind
Who is masked: Participant
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03735485
Sponsor's protocol ID: SevgiMC
Status last verified: Nov 2018
First submitted: 2 Nov 2018
Last updated: 8 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

Publications

Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
PubMed 8602410
Aytar A, Baltaci G, Uhl TL, Tuzun H, Oztop P, Karatas M. The effects of scapular mobilization in patients with subacromial impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. J Sport Rehabil. 2015 May;24(2):116-29. doi: 10.1123/jsr.2013-0120. Epub 2014 Jul 23.
PubMed 25054347
Bandholm T, Rasmussen L, Aagaard P, Jensen BR, Diederichsen L. Force steadiness, muscle activity, and maximal muscle strength in subjects with subacromial impingement syndrome. Muscle Nerve. 2006 Nov;34(5):631-9. doi: 10.1002/mus.20636.
PubMed 16921511
Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. doi: 10.2519/jospt.2000.30.3.126.
PubMed 10721508
Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756.
PubMed 20530557
Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
PubMed 21140113
Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
PubMed 26854052
Celik D, Atalar AC, Sahinkaya S, Demirhan M. [The value of intermittent ultrasound treatment in subacromial impingement syndrome]. Acta Orthop Traumatol Turc. 2009 May-Jul;43(3):243-7. doi: 10.3944/AOTT.2009.243. Turkish.
PubMed 19717942
de Witte PB, Nagels J, van Arkel ER, Visser CP, Nelissen RG, de Groot JH. Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM). BMC Musculoskelet Disord. 2011 Dec 14;12:282. doi: 10.1186/1471-2474-12-282.
PubMed 22168667
Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30.
PubMed 25936465
Haik MN, Alburquerque-Sendin F, Moreira RF, Pires ED, Camargo PR. Effectiveness of physical therapy treatment of clearly defined subacromial pain: a systematic review of randomised controlled trials. Br J Sports Med. 2016 Sep;50(18):1124-34. doi: 10.1136/bjsports-2015-095771. Epub 2016 Jun 10.
PubMed 27288517
Kim JJ, Lee SY, Ha K. The effects of exercise using PNF in patients with a supraspinatus muscle tear. J Phys Ther Sci. 2015 Aug;27(8):2443-6. doi: 10.1589/jpts.27.2443. Epub 2015 Aug 21.
PubMed 26356542
Lazaro R. Shoulder impingement syndromes: implications on physical therapy examination and intervention. J Jpn Phys Ther Assoc. 2005;8(1):1-7. doi: 10.1298/jjpta.8.1.
PubMed 25792938
Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Rheum. 2008 May 15;59(5):615-22. doi: 10.1002/art.23576.
PubMed 18438933
Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol). 2003 Jun;18(5):369-79. doi: 10.1016/s0268-0033(03)00047-0.
PubMed 12763431

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Subacromial Impingement trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises and Shoulder Mobilization Patients With Subacromial Impingement Syndrome: A Randomised Clinical Trial
ClinicalTrials.gov ID: NCT03735485
Acronym / sponsor ID: SevgiMC
Conditions: Subacromial Impingement, Subacromial Impingement Syndrome
Keywords: proprioceptive neuromuscular facilitation, functionality, mobilization, pnf
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Sevgi Medical CenterUniversity, hospital or other
Study start: 3 Mar 2017 (actual)
Primary completion: 2 Oct 2017 (actual)
Study completion: 10 Jan 2018 (actual)
First posted: 8 Nov 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 3
Model description: There were three study groups: 1. The control group: Participants in this group received only conventional physiotherapy treatment. 2. The shoulder mobilization group: Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques as treatment. The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises as treatment.

Arm	Type	Receives
Group I	Experimental	Other: Conventional PhysiotherapyThe control group. Participants in this group received only conventional physiotherapy. Number of the participants were 14.
Group II	Experimental	Other: Conventional Physiotherapy, Other: Shoulder MobilizationThe shoulder mobilization group. Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques. Number of the participants were 15.
Group III	Experimental	Other: Conventional Physiotherapy, Other: Proprioceptive Neuromuscular FacilitationThe Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises. Number of the participants were 15.

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged between 25-65 years old,
Having the diagnosis of Subacromial Impingement Syndrome (SIS),
Having shoulder pain at least for four weeks

Key exclusion criteria (13 listed)

Having a neuromuscular disease,
Pregnancy,
History of cancer,
Unstable angina,
Having pulmonary and/or vascular problems,

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
Conventional PhysiotherapyThe conventional physiotherapy program consisted of electrotherapy and exercise approaches. The electrotherapy program consisted of infrared (for 15 minutes, from 70 cm distance), conventional Transcutaneous Electrical Nerve Stimulation (TENS) in an encircled region (for 20 minutes; with 4 electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound (for 3 minutes; 1 megahertz (MHz), power: 1,5 W/cm²). A physiotherapist supervised exercise program was performed following the electrotherapy program. Elastic resistive exercises were added at the week three. While, the first set of wand exercises and elastic resistive exercises was performed under supervision, two sets of the showed exercises were given as the home exercise program.	Other	Group I, Group II, Group III
Shoulder MobilizationIn shoulder mobilization technique while the shoulder joint was placed in the traction, anterior, posterior, and inferior gliding and circumduction were applied to the humerus for 2-3 minutes. All mobilization applications were performed in painless range of motion (ROM) limits. The degree of traction and gliding were increased as the relaxing obtained in the tissues.	Other	Group II
Proprioceptive Neuromuscular FacilitationIn the Proprioceptive Neuromuscular Facilitation (PNF) program participants received PNF exercises with contract-relax technique, in the patterns of "flexion-abduction-external rotation", "extension-adduction-internal rotation", "flexion-adduction-external rotation" and "extension-abduction-internal rotation" along with the verbal and manual facilitation of the physiotherapist.	Other	Group III

Primary outcome

Shoulder pain: VAS
Time frame: Change from baseline pain scale of shoulder at week 2, 4 and 16.
Pain was defined with Visual Analog Scale (VAS). A 10-cm long horizontal visual analog scale (VAS) with marks 0 point (no pain) and 10 point (unbearable pain) was used for evaluating the pain severity. The patients were asked to mark the representing point of their pain levels. The values were recorded in cm. The pain severity was asked in three occasions as: at resting (VASr), during activity (VASa) and during night (VASn).
Disability of the shoulder
Time frame: Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) Score at week 2, 4 and 16.
The Disabilities of the Arm, Shoulder and Hand (DASH) Score was used to evaluate the upper extremity physical function. DASH includes two modules as disability / symptom section and work section. The scores are ranged between 0-100. Higher scores indicate lower functionality.
Function of the shoulder
Time frame: Change from baseline Constant-Murley score at week 2, 4 and 16.
In addition to DASH, the Constant-Murley score was used to evaluate the functionality of the shoulder. Constant-Murley score is a 100-point scoring system and consisted of four sub-scores as pain (15 points), daily living activities (20 points), active range of motion (40 points), and muscle strength (25 points).
Range of motion
Time frame: Change from baseline active range of motion at week 2, 4 and 16.
The active range of motion was assessed by using a universal goniometer.
Muscle Strength
Time frame: Change from baseline muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation at week 2, 4 and 16.
The muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation were determined by using Baseline Push-Pull (New York, USA) dynamometer. The dynamometer was placed in a 90 degrees angle on the location and the patient was asked to contract in maximum for two seconds and then maintain this position for five seconds. Two assessments were performed, and average values were recorded. Pain was avoided during the measurements.

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 8 Nov 2018.
Background: PubMed 8602410Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
Background: PubMed 25054347Aytar A, Baltaci G, Uhl TL, Tuzun H, Oztop P, Karatas M. The effects of scapular mobilization in patients with subacromial impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. J Sport Rehabil. 2015 May;24(2):116-29. doi: 10.1123/jsr.2013-0120. Epub 2014 Jul 23.
Background: PubMed 16921511Bandholm T, Rasmussen L, Aagaard P, Jensen BR, Diederichsen L. Force steadiness, muscle activity, and maximal muscle strength in subjects with subacromial impingement syndrome. Muscle Nerve. 2006 Nov;34(5):631-9. doi: 10.1002/mus.20636.
Background: PubMed 10721508Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. doi: 10.2519/jospt.2000.30.3.126.
Background: PubMed 20530557Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756.
Background: PubMed 21140113Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
Background: PubMed 26854052Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
Background: PubMed 19717942Celik D, Atalar AC, Sahinkaya S, Demirhan M. [The value of intermittent ultrasound treatment in subacromial impingement syndrome]. Acta Orthop Traumatol Turc. 2009 May-Jul;43(3):243-7. doi: 10.3944/AOTT.2009.243. Turkish.
Background: PubMed 22168667de Witte PB, Nagels J, van Arkel ER, Visser CP, Nelissen RG, de Groot JH. Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM). BMC Musculoskelet Disord. 2011 Dec 14;12:282. doi: 10.1186/1471-2474-12-282.
Background: PubMed 25936465Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30.
Background: PubMed 27288517Haik MN, Alburquerque-Sendin F, Moreira RF, Pires ED, Camargo PR. Effectiveness of physical therapy treatment of clearly defined subacromial pain: a systematic review of randomised controlled trials. Br J Sports Med. 2016 Sep;50(18):1124-34. doi: 10.1136/bjsports-2015-095771. Epub 2016 Jun 10.
Background: PubMed 26356542Kim JJ, Lee SY, Ha K. The effects of exercise using PNF in patients with a supraspinatus muscle tear. J Phys Ther Sci. 2015 Aug;27(8):2443-6. doi: 10.1589/jpts.27.2443. Epub 2015 Aug 21.
Individual participant dataSharing planned: Undecided. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

Related trials for Subacromial Impingement

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Recruiting
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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.

Tugba Kuru Colak, Asst. Prof. study director

Marmara University Institute of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. 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?

Shoulder pain: VAS (time frame: Change from baseline pain scale of shoulder at week 2, 4 and 16.). The study lists 5 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 NCT03735485, which also lists 22 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 8 Nov 2018.