NCT06402162

Brief Summary

This study aims to shed light on the supraspinatus and infraspinatus muscles, which play a significant role in rotator sheath tendinopathy and tears. It includes isometric measurements of muscle thickness, fiber length, and pennation angles, as well as muscle strength, using ultrasound to evaluate the muscle architecture of the supraspinatus and infraspinatus muscles in tennis players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

April 29, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

muscle thicknessfiber lengthpennation anglepain

Outcome Measures

Primary Outcomes (1)

  • visual pain scale

    The primary objective was to see if we could help to decrease the pain intensity of the patients by 4 units in a 10-unit VPS assessment.

    8 week

Secondary Outcomes (1)

  • ultrasonographic examination

    8 week

Study Arms (1)

muscle architecture

EXPERIMENTAL
Other: exercise

Interventions

The study will include 40 tennis players diagnosed with rotator cuff lesions who meet the inclusion criteria. The 1st group will be randomly divided into 2 groups as control (n=20) and 2nd group as core exercise (n=20). Unlike the control group, core exercises will be added to the routine exercise program of tennis players once a day, 3 days a week for 8 weeks.

muscle architecture

Eligibility Criteria

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

You may qualify if:

  • Acute trauma
  • Tendinosis
  • Bursitis chronic inflammation degeneration
  • Grade 1-2 rupture
  • Having unilateral shoulder pain
  • At least two specific tests must be positive (Neer-hawkings-Lag sign-drop arm and supraspinatus isolation tests; painful shoulder internal and external rotation against resistance (IR and ER); painful arch during abduction)

You may not qualify if:

  • An acute trauma
  • History of surgery or a fracture in or near the shoulder and shoulder
  • A neurological deficit
  • intra-articular injections in the last six months
  • Rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennis Club

Ankara, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Motor ActivityMuscle WeaknessRotator Cuff InjuriesPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study will include 40 tennis players diagnosed with rotator sheath lesions who meet the inclusion criteria. Groups will be randomly divided into 2. The 1st group will be randomly divided into 2 groups as control (n=20) and 2nd group as core exercise (n=20). Unlike the control group, core exercises will be added to the routine exercise program of tennis players once a day, 3 days a week, for 8 weeks. In both groups, pain will be assessed by Visual Analog Scale (VAS), muscle strength by isokinetic dynamometer and supraspinatus muscle architecture by ultrasonography and dynamic tendon imaging.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
haymana vocational high school physiotherapy

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 7, 2024

Study Start

May 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations