NCT07291843

Brief Summary

This assessor-blinded, three-arm, parallel-group randomized controlled trial investigated 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 were 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

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

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

December 6, 2025

Last Update Submit

July 23, 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 was assessed using a digital goniometer at target positions of 60 degrees of shoulder flexion and 60 degrees of shoulder abduction. The affected shoulder was passively positioned at the target angle, and the participant was allowed up to 10 seconds to memorize the position. The arm was then returned to the neutral position, and the participant was asked to actively reproduce the target position with the eyes closed. The absolute angular difference between the target position and the reproduced position was calculated in degrees. Three trials were conducted for flexion and three trials for abduction, and the mean absolute error for each direction was used in the analysis. Lower values 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 received the standardized conventional physiotherapy programme for four weeks and additionally received percussion massage therapy three times per week for four weeks.

Device: Percussion massage therapy deviceOther: Conventional Physiotherapy

IASTM Plus Conventional Physiotherapy

EXPERIMENTAL

Participants received the standardized conventional physiotherapy programme for four weeks and additionally received 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 received a standardized, supervised conventional physiotherapy programme five sessions per week for four weeks.

Other: Conventional Physiotherapy

Interventions

Instrument-assisted soft tissue mobilization was administered to the deltoid, supraspinatus, infraspinatus, and teres minor muscles three times per week for four weeks. All applications were performed by the same licensed physiotherapist. Standardized sweep and brush stroke techniques were applied at an approximate treatment angle of 45 degrees and in accordance with the anatomical fibre orientation of each muscle. For each muscle, 20 seconds of parallel strokes were followed by 20 seconds of perpendicular strokes using controlled sweeping movements. The intervention was provided in addition to the conventional physiotherapy programme.

Also known as: IASTM
IASTM Plus Conventional Physiotherapy

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

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

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme. The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

Conventional PhysiotherapyIASTM Plus Conventional PhysiotherapyPercussion Massage Therapy 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)

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Because of the nature of the interventions, participants and treating physiotherapists were aware of the allocated intervention. Outcome assessments were conducted by an independent physiotherapist who was blinded to group allocation. Statistical analyses were performed by a biostatistician blinded to coded group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were 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. Each participant remained in the assigned parallel intervention group throughout the four-week study period.
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

July 24, 2026

Record last verified: 2026-07

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning immediately after publication and available for five years.

Locations