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Shoulder Impingement SyndromeESWTNCT06076239

Effect of Extracorporeal Shock Wave Therapy in Impingement Syndrome

A study testing ESWT Group in people with Shoulder Impingement Syndrome and Trigger Point Pain, run by Istanbul Arel University 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
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Trial summary

Purpose: This study aimed to investigate the effectiveness of ESWT applied to trigger points on pain, function, and effusion in individuals diagnosed with shoulder impingement syndrome. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
ESWT Group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Mar 2022to 30 Jun 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having an active trigger point in the infraspinatus, supraspinatus, subscapularis muscles.
  • Positive impingement tests such as Hawkings, Neer and Jobe test, 60°-120° painful arc of motion are positive.
  • who were diagnosed with impingement syndrome by ultrasonography (USG) and clinical examination.

Who cannot join

  • patients with severe dementia or psychiatric disease,
  • diabetic patients with sensory problems,
  • and a history of malignancy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Private Olympos Hospital

    Antalya

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of ESWT Applied on the Trigger Point on Pain Function and Effusion in Individuals With Shoulder Impingement Syndrome

Purpose: This study aimed to investigate the effectiveness of ESWT applied to trigger points on pain, function, and effusion in individuals diagnosed with shoulder impingement syndrome.

Material and methods: This was a randomized controlled clinical trial with a total of 32 which were randomly divided into two equal groups (ESWT Group (EG), n = 16; Control Group (CG), n=16). The participants in the EG were given Extracorporeal Shock Wave Therapy to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) in addition to conventional treatment while CG received only conventional treatments for five days per week for 3 consecutive weeks. The primary outcome was pain intensity Visual analog scale (VAS). Secondary measurements were Tendon thickness and effusion with Ultrasound, Range of motion (ROM), Manual muscle testing (MMT), Corbin posture analysis, Constant Murley Score (CMS), Arm Shoulder and Hand Problems Questionnaire (DASH). Supraspinatus tendon thickness and effusion of the cases included in the study were evaluated by ultrasonography before and after the treatment(3 weeks) by the same specialist physician who was blind to the groups. Normal joint range of motion by universal goniometer, muscle strength by manual muscle test, posture evaluation by Corbin posture analysis, pain evaluation by Visual Analogue Scale (VAS), functional evaluation by Constant Murley Score (CMS), Arm Shoulder and Hand Problems Questionnaire (DASH) by physiotherapist It was evaluated before and after the treatment (3 weeks).

Read the detailed description

This study aimed to investigate the effectiveness of ESWT applied to trigger points on pain, function, and effusion in individuals diagnosed with shoulder impingement syndrome.

This was a randomized controlled clinical trial with a total of 32 which were randomly divided into two equal groups (ESWT Group (EG), n = 16; Control Group (CG), n=16). The participants in the EG were given Extracorporeal Shock Wave Therapy to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) in addition to conventional treatments , while CG received only conventional treatment for five days per week for 3 consecutive weeks. Conventional treatment consist of Ultrasound treatment (Gymna Pulson200) (1 mHz. treatment dose average 1.5 w/cm², intermittent with a small head (50%), 5 minutes ) around the glenohumeral joint of the cases in both groups participating in the study; at an intensity that the patient can tolerate, covering the painful area TENS (modified biphasic asymmetric pulse, and it was set to a pulse width of 100 μs and a frequency of 100 Hz, 20 min,) (Hometech ht 66b) applied; hotpack and exercises (posterior capsule stretching, wand exercises, mobilization approximately 60 minutes of conventional treatment consisting of exercises and shoulder isometric exercises) was applied once a day, 5 times a week in both groups. In addition to conventional physiotherapy. additional to conventional treatment EG was applied 1000 pulses to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles, 500 pulses to the surrounding area, 2 bars, ESWT (GYMNMA Shockmaster 500) was applied for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) at 10 Hz, medium energy level (<0.28 mJ/mm2).Supraspinatus tendon thickness and effusion of the cases included in the study were evaluated by ultrasonography before and after the treatment(3 weeks) by the same specialist physician who was blind to the groups. Normal joint range of motion by universal goniometer, muscle strength by manual muscle test, posture evaluation by Corbin posture analysis, pain evaluation by Visual Analogue Scale (VAS), functional evaluation by Constant Murley Score (CMS), Arm Shoulder and Hand Problems Questionnaire (DASH) by physiotherapist It was evaluated before and after the treatment (3 weeks).

Being tested
ESWT Group, Control Group
Keywords
extracorporeal shock wave therapy, shoulder pain
Medical subject headings
Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESWT GroupOther

    Also called EG

    EG were given Extracorporeal Shock Wave Therapy to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) in addition to conventional treatment. 1000 pulses to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles, 500 pulses to the surrounding area, 2 bars, ESWT (GYMNMA Shockmaster 500) was applied for a total of 5 sessions in 3 weeks at 10 Hz, medium energy level (<0.28 mJ/mm2).

  • Control GroupOther

    Also called CG

    Both EG and CG were given conventional treatment.Conventional treatment is consist of Ultrasound therapy (Gymna Pulson200) (1 mHz. treatment dose average 1.5 w/cm², intermittent with a small head (50%), 5 minutes (45)) around the glenohumeral joint of the cases in both groups participating in the study; TENS applied at an intensity that the patient can tolerate, covering the painful area (modified biphasic asymmetric pulse, and it was set to a pulse width of 100 μs and a frequency of 100 Hz, 20 min,) (Hometech ht 66b); hotpack and exercises (posterior capsule stretching, wand exercises, mobilization approximately 60 minutes of conventional treatment consisting of exercises and shoulder isometric exercises) was applied once a day, 5 times a week in both groups.

Study groups in NCT06076239
Study groupRoleWhat they receive
ESWT GroupExperimentalThe participants in the ESWT Group (n=16) were given Extracorporeal Shock Wave Therapy to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) in addition to conventional treatment.1000 pulses to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles, 500 pulses to the surrounding area, 2 bars, ESWT (GYMNMA Shockmaster 500) was applied for a total of 5 sessions in 3 weeks at 10 Hz, medium energy level (<0.28 mJ/mm2).
Receives: Other: ESWT Group
Control GroupActive comparatorControl group (n=16) received only conventional treatment for five days per week for 3 consecutive weeks. Conventional treatment includes Ultrasound therapy(Gymna Pulson200) (1 mHz. treatment dose average 1.5 w/cm², intermittent with a small head (50%), 5 minutes around the glenohumeral joint of the cases in both groups participating in the study; at an intensity that the patient can tolerate, covering the painful area TENS applied (modified biphasic asymmetric pulse, and it was set to a pulse width of 100 μs and a frequency of 100 Hz, 20 min,) (Hometech ht 66b); hotpack and exercises (posterior capsule stretching, wand exercises, mobilization approximately 60 minutes of conventional treatment consisting of exercises and shoulder isometric exercises) was applied once a day, 5 times a week in both groups.
Receives: Other: ESWT Group; Other: Control Group

What is being measured

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

  1. Pain intensity

    The Visual Analog Scale that is highly feasible for clinical research and practice to assess pain intensity was scored by means of a 10-cm long horizontal line ranging from (0 cm = no pain) at one end to (10 cm = maximum imaginable pain) at the other on which participants marked a point according to their subjective perception of pain

    Measured: 3 week

Secondary outcomes (7)
  1. Thickness of supraspinatus tendon

    Ultrasound is a reliable method of assessing the thickness of the tendon and having the advantages of being readily available, highly sensitive, relatively inexpensive, and non-invasive. The settings of the US system were standardized for all participants and remained the same for all measurements.

    Measured: 3 week

  2. Effusion in shoulder

    Ultrasound is a reliable method of assessing the thickness of the tendon and having the advantages of being readily available, highly sensitive, relatively inexpensive, and non-invasive. The settings of the US system were standardized for all participants and remained the same for all measurements.

    Measured: 3 week

  3. Shoulder ROM (flexion,extension,abduction,adduction,internal rotation,external rotation)

    The standard (universal) goniometer that is low cost, affordable, easy to be employed measurement tool to measure for range of motion in clinical evaluations of patients (33, 34). Universal 31-centimeter plastic 180° goniometer was used

    Measured: 3 week

  4. Shoulder muscle strength

    The manual muscle test (MMT) is a flexible diagnostic tool, which is used to assess muscle strength, a "muscle power function" according to the International Classification of Functioning, Disability, and Health is defined herein as the maximum voluntary resultant output that muscles can bring to bear on the environment under a specific set of test conditions (35). 6-degree scale ranging from palsy ("Gone-no contraction felt") up to full power ("normal-muscle can hold the test position against strong pressure''

    Measured: 3 week

  5. Corbin posture analyze

    Corbin Posture Analysis is a method in which postural changes are analyzed by observing the patient's current position. Analyzes are performed from lateral and posterior perspectives, and posture is scored according to the severity of the abnormality (0 = none, 1 = mild, 2 = moderate, 3 = severe). Postural scores obtained by posterior and lateral observation are summed and graded as poor ≥12, fair 8-11, good 5-7, very good 3-4 and excellent 0-2.

    Measured: 3 week

  6. Constant Murley Score

    The CMS is a standardized, a relatively unique, simple clinical method of assessing shoulder function and has a maximum score of 100 points, with both subjective (35 points) and objective (65 points) components for various shoulder pathologies (38). The subjective parameters assess the degree of pain perception (15 points) and the ability to perform the normal tasks of daily living in both activity- and position-related terms (20 points). The objective parameters include testing of active range of motion (40 points) and muscle strength (25 points). The calculation of the score is simple and easy. A higher score corresponds to better shoulder function.

    Measured: 3 week

  7. DASH

    The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire is the most commonly applied patient-reported outcome measure used to measure physical, psychological and social role function in clinical research and practice for patients with injuries and diseases of the upper extremities. The main component of the DASH is a 30-item scale concerning the patient's health status during the preceding week: 21 items regarding the degree of difficulty in performing certain physical activities; five items pertaining to the severity of pain, activity-related pain, tingling, weakness, and stiffness; and four items concerning the effect that the upper limb problem has had on social activities, work, sleep, and self-image. Each item is scored on a five-point ordinal scale. the DASH score results are inverted with the higher scores (maximum = 100) representing a greater disability and the lower scores occurring in a good functioning arm

    Measured: 3 week

Timeline

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

  1. First posted10 Oct 2023
  2. Study start3 Mar 2022
  3. Primary completion24 Jun 2022
  4. Study completion30 Jun 2022

Resources

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
The participants in the Experimental Group were given Extra Corporeal Shockwave therapy to the trigger point of the patients with a trigger point in one of the supraspinatus, subscapularis and infraspinatus muscles for a total of 5 sessions in 3 weeks (2 sessions in the first week, 2 sessions in the second week, 1 session in the third week) in addition to conventional treatments , while Control group received only conventional treatments for five days per week for 3 consecutive weeks
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06076239
Sponsor's protocol ID
5000009
Acronym
ESWT
Status last verified
Oct 2023
First submitted
3 Oct 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ESWT Group in people with Shoulder Impingement Syndrome and Trigger Point Pain, run by Istanbul Arel 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 3 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 10 Oct 2023. 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?

Pain intensity (time frame: 3 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Oct 2023.

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