Effect of Extracorporeal Shock Wave Therapy in Impingement Syndrome

NCT06076239 | Completed

• 1 other identifier: 5000009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Impingement Syndrome; Trigger Point Pain

Keywords

extracorporeal shock wave therapy; shoulder pain

Outcome Measures

Primary Outcomes (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

  3 week

Secondary Outcomes (7)

• Thickness of supraspinatus tendon

  3 week

• Effusion in shoulder

  3 week

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

  3 week

• Shoulder muscle strength

  3 week

• Corbin posture analyze

  3 week

Study Arms (2)

ESWT Group

EXPERIMENTAL

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).

Other: ESWT Group

Control Group

ACTIVE COMPARATOR

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.

Other: ESWT Group; Other: Control Group

Interventions

ESWT Group 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).

Also known as: EG

Control Group; ESWT Group

Control Group 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.

Also known as: CG

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Arel University: lead

Study Sites (1)

Private Olympos Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Seçil Özkurt, Phd

  İstanbul Arel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Supraspinatus tendon thickness and effusion of the cases included in the study were evaluated by ultrasonography before and after the study by the same specialist physician who was blind to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: 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

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: March 3, 2022
• Primary Completion: June 24, 2022
• Study Completion: June 30, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

TU (1)