Clinical trial NCT06076239: Effect of Extracorporeal Shock Wave Therapy in Impingement Syndrome
Official title: Effect of ESWT Applied on the Trigger Point on Pain Function and Effusion in Individuals With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Trigger Point Pain
Keywords: extracorporeal shock wave therapy
shoulder pain
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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).

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Pain intensity
timeFrame: 3 week
Secondary outcomes:
measure: Thickness of supraspinatus tendon
timeFrame: 3 week
measure: Effusion in shoulder
timeFrame: 3 week
measure: Shoulder ROM (flexion,extension,abduction,adduction,internal rotation,external rotation)
timeFrame: 3 week
measure: Shoulder muscle strength
timeFrame: 3 week
measure: Corbin posture analyze
timeFrame: 3 week
measure: Constant Murley Score
timeFrame: 3 week
measure: DASH
timeFrame: 3 week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Private Olympos Hospital
Study officials:
affiliation: İstanbul Arel University
name: Seçil Özkurt, Phd
role: STUDY_DIRECTOR
References: