NCT07291843

Brief Summary

This randomized controlled clinical study aims to investigate the effects of vibration therapy and instrument-assisted soft tissue mobilization (IASTM), when added to conventional physiotherapy, on pain, range of motion, proprioception, functional status, and quality of life in individuals diagnosed with subacromial impingement syndrome (SAIS). SAIS is one of the most common causes of shoulder pain and is frequently associated with impaired scapular kinematics, rotator cuff dysfunction, soft tissue tightness, and decreased shoulder mobility. A total of 48 participants aged 40-60 years with MRI-confirmed SAIS will be randomly assigned into three groups: (1) Vibration Therapy + Conventional Physiotherapy, (2) IASTM + Conventional Physiotherapy, and (3) Conventional Physiotherapy (Control). All interventions will be administered three times per week for four weeks. Outcomes include pain intensity (VAS), shoulder range of motion (Goniometer Pro app), proprioception at 60° of flexion and abduction, functional status (DASH), and quality of life (RC-QoL). The study aims to determine whether adding vibration therapy or IASTM to standard physiotherapy provides additional short-term benefits in reducing pain, improving joint mobility, enhancing proprioceptive acuity, and increasing functional capacity in individuals with subacromial impingement syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 6, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

December 6, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

Subacromial Impingement SyndromeShoulder PainInstrument-Assisted Soft Tissue Mobilization (IASTM)Vibration TherapyPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Assessment of Joint Position Sense (Proprioception)

    Joint position sense will be assessed using the Becure Extremity ROM system. Proprioception will be evaluated at 60 degrees of shoulder flexion and shoulder abduction. While standing, each participant will first be asked to lift their arm with eyes open and memorize the arm position at 60 degrees. Then, with eyes closed, the participant will be instructed to raise the arm to the same position previously reached with eyes open. The shoulder angle will be measured while the eyes are closed. The difference between the angles recorded with eyes open and eyes closed will be considered the joint position error. This procedure will be performed for both shoulder flexion and abduction at 60 degrees.

    4 week

Secondary Outcomes (4)

  • Pain Assessment (Visual Analog Scale - VAS)

    4 week

  • Range of motion (ROM)

    4 week

  • Functionality (Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH)

    4 week

  • Quality of Life (Rotator Cuff Quality of Life Questionnaire - RC-QoL)

    4 week

Study Arms (3)

Conventional Physiotherapy

ACTIVE COMPARATOR

All participants will receive a total of 12 sessions of conventional therapy and exercise, administered three days per week for four weeks. The conventional therapy program will include 8 minutes of ultrasound, 30 minutes of TENS (Transcutaneous Electrical Nerve Stimulation), and 15 minutes of cryotherapy. The exercise program will consist of passive stretching performed by the physiotherapist, as well as supervised exercises including Codman pendulum exercises, wand-assisted exercises, finger ladder exercises, and strengthening exercises tailored to the patient's condition. All exercises will be applied progressively based on the participant's tolerance and clinical status.

Other: Conventional physiotherapy

Vibration Therapy Group

EXPERIMENTAL

Participants in this group will receive vibration therapy in addition to conventional physiotherapy methods. The vibration application (33 Hz) will be administered using a percussion massage device (Compex Fixx 2.0) to the M. Deltoideus, M. Supraspinatus, M. Infraspinatus, and M. Teres Minor muscles. The treatment will be applied along the origin-to-insertion line of each muscle for 3 minutes per muscle. The device will be moved in a straight longitudinal path along the muscle fibers, progressing from proximal to distal and then returning to the proximal segment. Each stroke will last approximately five seconds. Vibration therapy will be applied using the soft-head attachment of the percussion device. The vibration intervention will be carried out three times per week for a total of four weeks.

Device: Percussion massage therapy deviceOther: Conventional physiotherapy

IASTM Group

EXPERIMENTAL

In the IASTM group, participants will receive instrument-assisted soft tissue mobilization three days per week for four weeks, for a total of 12 sessions, following the conventional physiotherapy treatment. The technique will be applied with the participant in a supine position to the anterior muscle groups, including the subscapularis, anterior deltoid, pectoralis major, pectoralis minor, and biceps brachii muscles. The participant will then be placed in a prone position to treat the posterior muscle groups, including the upper trapezius, supraspinatus, infraspinatus, teres major, teres minor, and posterior deltoid muscles. Each muscle group will receive treatment at a 45-degree angle using sweep and brush techniques, consisting of 20 seconds of parallel strokes and 20 seconds of perpendicular strokes.

Device: Instrument-assisted soft tissue mobilization deviceOther: Conventional physiotherapy

Interventions

Instrument-assisted soft tissue mobilization was performed using specially designed stainless-steel tools applied at a 45-degree angle to the anterior and posterior shoulder muscles. Sweep and brush techniques were used, consisting of approximately 20 seconds of parallel strokes and 20 seconds of perpendicular strokes per muscle group. The intervention was administered three times per week for four weeks following the conventional physiotherapy session.

IASTM Group

Vibration therapy was applied using a handheld percussion massage gun (Compex Fixx 2.0) delivering vibration at 33 Hz with a soft-head attachment. The device was moved longitudinally along the deltoid and rotator cuff muscles (supraspinatus, infraspinatus, teres minor) in a proximal-to-distal direction. Each muscle was treated for approximately 3 minutes per session. The intervention was delivered three times per week for four weeks.

Vibration Therapy Group

Conventional physiotherapy consisting of 8 minutes of therapeutic ultrasound, 30 minutes of TENS, 15 minutes of cryotherapy, and a supervised exercise program including passive stretching, Codman pendulum exercises, wand exercises, finger ladder exercises, and progressive strengthening. The program is delivered three times per week for four weeks.

Conventional PhysiotherapyIASTM GroupVibration Therapy Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with subacromial impingement syndrome confirmed by MRI
  • Men and women between 40 and 60 years of age
  • Presence of symptoms for more than one month

You may not qualify if:

  • History of surgery on the affected arm
  • Presence of an open wound on the arm
  • Existing infection
  • Inflammatory joint disease
  • Shoulder osteoarthritis
  • Presence of rheumatic disease
  • Malignant or benign tumors
  • Inability to tolerate vibration therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emre Dansuk

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emre Dansuk, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a three-arm parallel-group randomized controlled design in which participants diagnosed with subacromial impingement syndrome are randomly assigned to one of three intervention groups: (1) Vibration Therapy combined with Conventional Physiotherapy, (2) Instrument-Assisted Soft Tissue Mobilization (IASTM) combined with Conventional Physiotherapy, or (3) Conventional Physiotherapy alone. All groups receive interventions three times per week for four weeks. Outcomes are compared between groups to determine the additional effects of vibration therapy and IASTM beyond standard physiotherapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 18, 2025

Study Start

December 10, 2025

Primary Completion

February 1, 2026

Study Completion

February 15, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations