NCT07410260

Brief Summary

Background: The aim of this study was to investigate the effects of extracorporeal shock wave therapy (ESWT) on pain, upper extremity functional level and sleep quality in subacromial impingement syndrome. Methods: Thirty patients diagnosed with impingement syndrome were randomly divided into two groups. ESWT group, ESWT was applied one day a week in addition to a conventional physiotherapy programme consisting of ultrasound, transcutaneous electrical nerve stimulation (TENS), infrared and exercise 5 days a week for three weeks. Control group received only conventional physiotherapy programme. Constant Murley Shoulder Score (CMS), The University of California-Los Angeles (UCLA) shoulder scale, Shoulder Pain and Disability Index (SPADI), Short Form Mc-Gill Pain Questionnaire (SF-MPQ ), VAS and Pittsburgh Sleep Quality Index (PSQI) were used in the evaluation. Joint range of motion was assessed using a universal goniometer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 21, 2026

Last Update Submit

February 7, 2026

Conditions

Keywords

shoulder impingement syndromeExtracorporeal shock wave therapysubacromial impingement syndrome

Outcome Measures

Primary Outcomes (3)

  • Evaluation of joint range of motion

    Shoulder joint active and passive flexion, extension, abduction, internal and external rotation range of motion was evaluated before and after treatment with universal goniometer.

    Baseline and end of Week 3

  • Pain assessment

    Shoulder pain assessment of the patients before and after treatment was performed with VAS and Short Form Mc-Gill Pain Questionnaire (SF-MPQ). The SF-MPQ provides information about the sensory, perceptual and intensity dimensions of pain by describing the pain. Pain is characterised by a total of 15 descriptive adjectives, 11 sensory and 4 affective. The total pain intensity of the patient was evaluated with a 6-point Likert-type scale as 0=no pain, 1=mild, 2=moderate, 3=severe, 4=bitter, 5=unbearable

    Baseline and end of Week 3

  • Functional assessment

    Functional evaluation of the shoulder joint was performed before and after treatment using the University of California-Los Angeles (UCLA) Shoulder Scale, the Shoulder Pain and Disability Index (SPADI), and the Constant-Murley Shoulder Score (CMS). SPADI consists of two subscales assessing pain and disability, each scored from 0 to 100, with higher scores indicating greater pain and functional limitation. CMS evaluates shoulder pain, activities of daily living, range of motion, and muscle strength, yielding a total score of 100 points; higher scores reflect better shoulder function and are categorized as excellent, good, fair, or poor. The UCLA Shoulder Scale has a total score of 35 points, including pain (10 points), function (10 points), range of motion (10 points), and patient satisfaction (5 points), with higher scores indicating better outcomes.

    Baseline and end of Week 3

Secondary Outcomes (1)

  • Sleep assessment

    Baseline and end of Week 3

Study Arms (2)

ESWT Gruop

EXPERIMENTAL
Other: Conventional treatment programmeOther: Exercise programmeOther: Extracorporeal Shock Wave Therapy

Control group

ACTIVE COMPARATOR
Other: Conventional treatment programmeOther: Exercise programme

Interventions

Ultrasound; Chattanooga® (US) 2776 model device, 3 MHz, treatment dose average 1.5 w/cm², 5 min ultrasound was applied to the anterior and posterior of the glenohumeral joint. Transcutaneous Electrical Nerve Stimulation (TENS); With Chattanooga®(US) 2770 model device, conventional TENS application with a frequency between 60 and 120 Hz and a transition time of 50-100 μsec was applied to the shoulder joint by interposing the painful area of the patient for 20 minutes. Infrared; Infrared rays were positioned perpendicularly to the pathological shoulder region of the patients with Orthocare®(Turkey) device and applied from a distance of 45-70 cm for 20 minutes.

Control groupESWT Gruop

An exercise programme was prescribed to the patients according to the evaluations. Within the scope of this programme, Codman pendulum, Wand, isometric, isotonic exercises, strengthening with resistance bands, stretching exercises (capsule stretches), strengthening exercises for the surrounding joints were taught. The exercises were performed once a day with a physiotherapist and twice a day as a home programme

Control groupESWT Gruop

Extracorporeal Shock Wave Therapy (ESWT) was performed with EMS Swiss DolorClast® Master(Switzerland) device with 1.6 bar pressure, 11.0 Hz frequency, medium energy (0.28 mj/mm²) and 2000 pulses. The application area was applied to the anatomical region compatible with the pathology, such as subraspinatus tendon, biceps brachi long head supacromial space, where pain and symptoms were concentrated. Treatment parameters were decided according to the pain limit and the optimal treatment dose specified in the literature. ESWT was applied once a week for three weeks (Huisstede, B. M. et al. 2011).

ESWT Gruop

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer patients aged 18-65 years
  • Unilateral shoulder impingement, stage 1 or stage 2
  • No participation in any treatment program within the last 3 months

You may not qualify if:

  • Acute infection
  • Hemophilia or blood coagulation disorders
  • Cervical radiculopathy
  • History of shoulder fracture or dislocation
  • History of shoulder or neck surgery
  • Presence of a pacemaker
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye Üniversitesi

Istanbul, Merkez, 08100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 13, 2026

Study Start

January 1, 2019

Primary Completion

November 20, 2019

Study Completion

December 20, 2019

Last Updated

February 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.

Locations