Effect of Extracorporeal Shock Wave Therapy in Impingement Syndrome

NCT ID: NCT06076239

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2022-06-30

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).

Conditions

Shoulder Impingement Syndrome; Trigger Point Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT Group

The 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).

Group Type: EXPERIMENTAL

ESWT Group

Intervention Type: OTHER

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 Group

Control 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.

Group Type: ACTIVE_COMPARATOR

ESWT Group

Intervention Type: OTHER

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 Group

Intervention Type: OTHER

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.

Interventions

ESWT Group

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).

Intervention Type: OTHER

Control Group

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.

Intervention Type: OTHER

Other Intervention Names

EG; CG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Arel University

OTHER

Sponsor Role: lead

Responsible Party

Seçil ÖZKURT

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seçil Özkurt, Phd

Role: STUDY_DIRECTOR

İstanbul Arel University

Locations

Private Olympos Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

5000009

Identifier Type: -

Identifier Source: org_study_id