NCT06899945

Brief Summary

This study aims to investigate the effects of vibration therapy applied at different frequencies using a percussion massage gun on pain, range of motion (ROM), functionality, joint position sense, and quality of life in individuals with rotator cuff syndrome. Rotator cuff syndrome is a common shoulder disorder caused by excessive use, muscle weakness, trauma, or instability, leading to pain, restricted movement, and reduced functional capacity. Although percussion massage therapy has gained popularity for its potential therapeutic benefits, there is limited scientific evidence on its effectiveness in improving ROM, pain reduction, and functional outcomes. A total of 48 participants diagnosed with rotator cuff lesions will be included in the study and divided into three groups: Vibration Group (33 Hz) Vibration Group (16.7 Hz) Control Group (Conventional Physiotherapy) The intervention will include: Conventional physiotherapy exercises applied to all groups, Vibration therapy with a percussion massage gun applied to the experimental groups, targeting the deltoid, supraspinatus, infraspinatus, and teres minor muscles for three minutes per muscle, three times per week for three weeks. Outcome Measures: Pain: Visual Analog Scale (VAS) ROM \& Joint Position Sense: Measured using the Goniometer Pro mobile application Functionality: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire Quality of Life: Rotator Cuff Quality of Life (RC-QoL) questionnaire Hypotheses: Vibration therapy at different frequencies will significantly impact pain, ROM, functionality, joint position sense, and quality of life. 33 Hz vibration therapy will be more effective than 16.7 Hz in improving outcomes. The data will be analyzed using SPSS 25, with statistical tests applied based on data distribution. This research aims to contribute to the understanding of vibration therapy's role in managing rotator cuff syndrome and its effectiveness in clinical rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 21, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

March 21, 2025

Last Update Submit

August 24, 2025

Conditions

Keywords

Rotator Cuff SyndromeVibration TherapyPainFunctionalityProprioceptionQuality of life

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Joint Position Sense

    The joint position sense of the participants in the study will be measured using the Fizyosoft Extremity ROM system. Joint position sense will be evaluated in 60-degree shoulder flexion and abduction movements. Participants will be asked to lift their arm to 60 degrees with their eyes open and remember the position. Then, they will be instructed to replicate the same movement with their eyes closed. The shoulder angle will be measured while their eyes are closed. The difference between the open-eye and closed-eye measurements will be recorded as the joint position sense. This method will be applied at 60-degree shoulder flexion and abduction .The average of two trials will consider for data evaluation.

    3 weeks

Secondary Outcomes (4)

  • Visual Analogue Scale

    3 weeks

  • Range of Motion

    3 weeks

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire

    3 weeks

  • Assessment of Quality of Life

    3 weeks

Study Arms (3)

Control Group (Conventional Physiotherapy)

ACTIVE COMPARATOR

Participants in the control group will receive only conventional physiotherapy without vibration therapy. This ensures a baseline comparison to assess the effectiveness of vibration therapy. Treatment Modalities: TENS therapy (20 minutes, 100 Hz) Mobility exercises (wand exercises, Codman exercises, active/passive stretching) Strengthening exercises (theraband-based training) Frequency: 5 sessions per week Total Treatment Period: 3 weeks

Other: conventional physiotherapy program

Vibration Therapy (16.7 Hz) Group

EXPERIMENTAL

This group will receive vibration therapy at 16.7 Hz using a percussion massage gun (Hypervolt device (Hyperice, CA, USA)) along with a standard physiotherapy program. The treatment protocol mirrors the 33 Hz group, except for the vibration frequency. Duration: 3 minutes per muscle Frequency: 3 times per week Total Treatment Period: 3 weeks Additional Treatment: Standard physiotherapy (TENS, mobility exercises, and strengthening)

Device: a percussion massage gun (Hypervolt device (Hyperice, CA, USA))Other: conventional physiotherapy program

Vibration Therapy (33 Hz) Group

EXPERIMENTAL

Participants in this group will receive vibration therapy at 33 Hz using a percussion massage gun (Hypervolt device (Hyperice, CA, USA)) in addition to a standard physiotherapy program. The therapy will target the deltoid, supraspinatus, infraspinatus, and teres minor muscles, applying vibration along the origin-insertion pathway. Duration: 3 minutes per muscle Frequency: 3 times per week Total Treatment Period: 3 weeks Additional Treatment: Standard physiotherapy (TENS, mobility exercises, and strengthening)

Device: a percussion massage gun (Hypervolt device (Hyperice, CA, USA))Other: conventional physiotherapy program

Interventions

Vibration application will be applied to the individuals in this group in addition to conventional methods. Vibration application will be applied to the deltoid, supraspinatus, infraspinatus, and teres minor muscles with a percussion massage gun (Hypervolt device (Hyperice, CA, USA)) along the origo-insertio line for 3 minutes for each muscle group. Vibration application will be performed using the soft head of the percussion massage gun. Vibration therapy will be applied 3 days a week for 3 weeks.

Vibration Therapy (16.7 Hz) GroupVibration Therapy (33 Hz) Group

Participants in the conventional physiotherapy program will follow a 3-week exercise plan, with sessions 5 days per week, each lasting 30 minutes under physiotherapist supervision. Treatment includes: TENS therapy (20 min, 100 Hz) on the painful area. Wand exercises for flexion, abduction, extension, internal, and external rotation (10 reps/set). Codman exercises for flexion, abduction, and circular movements (10 reps/set). Active \& passive stretching for flexion, abduction, internal, and external rotation (10 reps/set). Finger ladder exercises for flexion and abduction (10 reps/set). Strengthening with a theraband for flexion, abduction, external/internal rotation, and extension, adjusted based on progress (10 reps/set). This exercise program will be applied to all study groups.

Control Group (Conventional Physiotherapy)Vibration Therapy (16.7 Hz) GroupVibration Therapy (33 Hz) Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with rotator cuff lesion,
  • Experiencing shoulder pain for at least 3 weeks,
  • Aged between 30-60 years,
  • Having restricted shoulder range of motion.

You may not qualify if:

  • Individuals with an additional orthopedic or neurological disorder affecting the shoulder,
  • Those with a history of previous shoulder trauma,
  • Individuals who have participated in a physiotherapy program within the last 3 months,
  • Those unable 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

Pain

Condition Hierarchy (Ancestors)

Neurologic 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: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

March 25, 2025

Primary Completion

June 25, 2025

Study Completion

July 20, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations