NCT07756203

Brief Summary

This assessor-blinded, three-arm, parallel-group randomized controlled trial will investigate the additional effects of percussion massage therapy and instrument-assisted soft tissue mobilization in individuals with subacromial impingement syndrome. Forty-eight participants aged 40-60 years with clinically and magnetic resonance imaging-confirmed subacromial impingement syndrome will be randomly allocated in a 1:1:1 ratio to conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy. All groups received a standardized four-week conventional physiotherapy programme. Participants in the percussion massage therapy and instrument-assisted soft tissue mobilization groups additionally received their respective interventions three times per week for four weeks. Outcomes were evaluated at baseline and immediately after the four-week intervention. The primary outcome was shoulder joint position sense during flexion and abduction. Secondary outcomes were shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life.

Trial Health

63
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Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress4%
Aug 2026Oct 2026

First Submitted

Initial submission to the registry

August 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 3, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder Joint Position Sense Error

    Shoulder joint position sense will be assessed using a digital goniometer at target positions of 60° of shoulder flexion and 60° of shoulder abduction. The affected shoulder will be passively positioned at the target angle, and the participant will be allowed up to 10 seconds to memorize the position. The arm will then be returned to the neutral position, and the participant will be asked to actively reproduce the target position with their eyes closed. The absolute angular difference between the target position and the reproduced position will be calculated in degrees. Three trials will be conducted for flexion and three trials for abduction, and the mean absolute error for each direction will be used in the analysis. Lower values will indicate greater joint position sense accuracy.

    Baseline and immediately after the 4-week intervention

Secondary Outcomes (4)

  • Change in Shoulder Range of Motion

    Baseline and immediately after the 4-week intervention

  • Change in Resting and Activity-Related Shoulder Pain

    Baseline and immediately after the 4-week intervention

  • Change in Upper-Extremity Disability

    Baseline and immediately after the 4-week intervention

  • Change in Rotator Cuff-Related Quality of Life

    Baseline and immediately after the 4-week intervention

Study Arms (3)

Percussion Massage Therapy Plus Conventional Physiotherapy

EXPERIMENTAL

Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive percussion massage therapy three times per week for four weeks.

Device: Percussion massage therapy deviceOther: Conventional Physiotherapy

IASTM Plus Conventional Physiotherapy

EXPERIMENTAL

Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive instrument-assisted soft tissue mobilization three times per week for four weeks.

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

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants will receive a standardized, supervised conventional physiotherapy programme five sessions per week for four weeks.

Other: Conventional Physiotherapy

Interventions

Percussion massage therapy will be administered using a handheld Hypervolt device (Hyperice, California, USA) at 33 Hz, corresponding to level 2 of the device. A flat-head attachment will be used to provide uniform contact with the treated tissues. The intervention will be applied to the deltoid, supraspinatus, infraspinatus, and teres minor muscles along their anatomical fibre orientation. Each muscle will be treated for three minutes using controlled longitudinal strokes applied alternately in proximal-to-distal and distal-to-proximal directions. The intervention will last 12 minutes per session and will be administered by the same licensed physiotherapist three times per week for four weeks. It will be provided in addition to the 30-minute conventional physiotherapy programme, resulting in a total session duration of 42 minutes.

Also known as: Hypervolt Percussion Massage Device
Percussion Massage Therapy Plus Conventional Physiotherapy

Participants will receive supervised conventional physiotherapy from a licensed physiotherapist five times weekly for four weeks. Each standard 30-minute session will include 20 minutes of TENS to the symptomatic shoulder at 100 Hz and 10 minutes of exercise. Exercises will comprise wand-assisted shoulder movements, Codman pendulum exercises, active and passive stretching, finger-ladder exercises, and elastic-band strengthening for flexion, abduction, extension, and internal and external rotation. Exercises will be performed for 10 repetitions per set, with resistance progressed according to pain, function, and tolerance. To match treatment duration and therapist contact, the control group will perform an additional standardized 12-minute exercise block during three sessions weekly, including one extra set of range-of-motion and resistance exercises. Sessions will therefore last 42 minutes on three days and 30 minutes on two days weekly.

Conventional PhysiotherapyIASTM Plus Conventional PhysiotherapyPercussion Massage Therapy Plus Conventional Physiotherapy

Instrument-assisted soft tissue mobilization will be administered to the deltoid, supraspinatus, infraspinatus, and teres minor muscles three times per week for four weeks. All applications will be performed by the same licensed physiotherapist. Standardized sweep and brush stroke techniques will be applied at an approximate treatment angle of 45° according to the anatomical fibre orientation of each muscle. For each muscle, 90 seconds of parallel strokes will be followed by 90 seconds of perpendicular strokes using controlled sweeping movements. The intervention will last three minutes per muscle and 12 minutes per session. It will be provided in addition to the 30-minute conventional physiotherapy programme, resulting in a total session duration of 42 minutes.

Also known as: IASTM
IASTM Plus Conventional Physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Men or women aged 40 to 60 years.
  • Diagnosis of subacromial impingement syndrome confirmed by clinical examination and -magnetic resonance imaging.
  • Positive Neer test.
  • Positive Hawkins-Kennedy test.
  • Positive painful arc test.
  • Shoulder symptoms persisting for at least one month.
  • Ability and willingness to participate in the assessment and intervention programme.
  • Provision of written informed consent.

You may not qualify if:

  • Previous surgery involving the affected upper extremity.
  • Inflammatory joint disease.
  • Shoulder osteoarthritis.
  • Rheumatic disease.
  • Malignant or benign tumour affecting the shoulder region or upper extremity.
  • Open wound or active infection in the shoulder region.
  • Inability to tolerate vibration-based therapy.
  • Inability to comply with the study protocol or intervention programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 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

Central Study Contacts

Emre Dansuk, PhD

CONTACT

Burak Menek, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Because of the nature of the interventions, participants and treating physiotherapists will be aware of the allocated intervention. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Physiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 10, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes. Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements. Supporting Information: Study Protocol Time Frame: Beginning immediately after publication and available for five years. Access Criteria: URL:

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning immediately after publication and available for five years. Access Criteria: URL:
Access Criteria
Data will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the corresponding author and will require institutional approval and a signed data-sharing agreement. Data will be provided solely for the purposes specified in the approved proposal.

Locations