NCT07005856

Brief Summary

The aim of this study is to investigate the immediate effects of soft tissue mobilization on shoulder mobility, pain, scapular kinematics and muscle activation and muscle Stiffness in symptomatic overhead athletes with posterior shoulder tightness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

April 14, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

Posterior shoulder tightnesssubacromial impingement

Outcome Measures

Primary Outcomes (5)

  • Shoulder average pain intensity

    Pain is measured with Visual Analogue scale (VAS) Score range from 0 to 10. Scoring of 0 represents no pain and scoring of 10 represents pain as bad as it could possibly be.

    Immediately after the single session

  • Shoulder passive range of motion (measured with goniometer)

    Shoulder external rotation, internal rotation, horizontal adduction range of motion in shoulder flexion 90 degrees

    Immediately after the single session

  • Shoulder active range of motion (measured with goniometer)

    Shoulder external rotation, internal rotation, horizontal adduction range of motion in shoulder flexion 90 degrees

    Immediately after the single session

  • Perceived improvement

    Perceived improvement was assessed through the GROC scale. Global Rating of Change (GROC) scale was used to assess the participant's perceived improvement. The scale ranges from -7 to +7, where -7 indicates a very great deal worse, 0 indicates no change, and +7 indicates a very great deal better. Higher scores reflect greater perceived improvement.

    Immediately after the single session

  • Shoulder muscle stiffness

    Mean dynamic muscle stiffness (N/m) of shoulder posterior muscles (deltoid, infraspinatus, teres minor) measured by MyotonPRO

    Immediately after the single session

Secondary Outcomes (2)

  • Surface electromyography (TeleMyo2400T G2, Noraxon USA Inc., Scottsdale, AZ, USA)

    Immediately after the single session

  • Scapular kinematics (degrees) during shoulder elevation measured by VIPERâ„¢ system

    Immediately after the single session

Study Arms (3)

Soft tissue mobilization group

EXPERIMENTAL
Other: Soft tissue mobilization

Stretching group

EXPERIMENTAL
Other: Stretching

Hot pack group

ACTIVE COMPARATOR
Other: Hot pack

Interventions

Soft tissue mobilization: mobilization participants' soft tissue by using hands

Soft tissue mobilization group

Stretching: help patients do the movement that they're limited to stretch their soft tissue

Stretching group

Add an hot pack on participants' shoulder

Also known as: heat therapy
Hot pack group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Amateur overhead athletes aged 18-50 years.
  • Participation in overhead sports training for more than 4 hours per week.
  • Playing experience of more than 3 years.
  • Shoulder range of motion deficits: internal rotation range of motion (ROM) on the affected side is at least 10 degrees less than the unaffected side, and total rotational ROM (internal rotation + external rotation) is at least 5 degrees less than the unaffected side, or horizontal adduction ROM is at least 10 degrees less than the unaffected side.
  • Patients with subacromial pain syndrome: diagnosis requires at least 3 out of 5 positive test results (Hawkins-Kennedy impingement test, Neer impingement test, Empty Can test, Painful Arc test, and External Rotation Resistance test).

You may not qualify if:

  • Negative result on the kinetic medial rotation test.
  • History of shoulder fracture, dislocation, or upper limb injury requiring surgery within the past 6 months.
  • Inability to complete the experiment due to personal factors.
  • Shoulder pain intensity greater than 7 points on the Visual Analog Scale (VAS).
  • History of direct trauma to the neck or upper limb within the past month. Shoulder pain and neurological symptoms originating from the cervical spine. Contraindications to soft tissue mobilization, such as open wounds in the treatment area, skin cancer, localized infection, severe edema, vascular disorders, or acute muscle tears in the treatment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2025

First Posted

June 5, 2025

Study Start

May 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

June 5, 2025

Record last verified: 2024-05

Locations