NCT06838247

Brief Summary

The purpose of the study is to reveal whether there are concurrent shoulder lesions in patients with hand injuries. Its importance is that it will shed light on whether not only the hand but also the shoulder should be included in the treatment program in hand rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Nov 2024Jul 2026

Study Start

First participant enrolled

November 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

February 16, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

Hand injuriesShoulderDiagnosticUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic shoulder ultrasonography

    For shoulder ultrasonography, the specialist physician and the patient will sit opposite each other. The examination will be performed using high-resolution linear probes. Standard ultrasonography technique and diagnosis will be used, and real-time ultrasonography will be performed with an ultrasound device with a 6-11 MHz linear wide-band probe (Nemio XH, Toshiba, Japan). In shoulder ultrasonography, the long head of the biceps brachialis muscle, supraspinatus tendon and subacromial bursa will be examined. Fluid increase or edema in the subacromial bursa will be evaluated to determine whether there is subacromial bursitis. In case of suspected supraspinatus tendon rupture, the contour integrity, echogenicity and thickness of the tendon will be carefully examined; in addition, it will be determined whether there is a partial or complete tear on the tendon.

    up to 12 weeks

Secondary Outcomes (4)

  • Visual analog scale (VAS) scores

    up to 12 weeks

  • Joint range of motion

    up to 12 weeks

  • Handgrip Strength Test

    up to 12 weeks

  • The Shoulder Pain and Disability Index

    up to 12 weeks

Study Arms (2)

Case

Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo routine shoulder examination as well as hand examination. The group with shoulder symptoms and examination findings will constitute the case group.

Control

The group with a normal shoulder examination and ultrasonographic findings will be the control group.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo a routine shoulder examination as well as a hand examination. The group with shoulder symptoms and examination findings will constitute the case group, and the group with a normal shoulder examination will constitute the control group. Age, gender, height, weight, occupation, dominant hand, type of injury, type of injury, duration of injury, operation time, and immobilization time will be recorded for both groups.

You may qualify if:

  • Having a history of hand injury and applying for hand rehabilitation after surgical and conservative treatment.

You may not qualify if:

  • Being under 18 and over 65 years of age
  • Patients with systemic diseases (Diabetes mellitus, Peripheral vascular diseases)
  • Any rheumatic disease involving the hand and upper extremity
  • History of neuropathy involving the hand and upper extremity
  • Those with any shoulder problems prior to the hand injury
  • Those with an open wound on the hand
  • Those who cannot cooperate
  • Other upper extremity traumatic injuries occurring during the hand injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Abdallah EA, Eldesoky MT, Saweres JW, Abdelhaleem MD. Effect of Adding Shoulder Stabilization Exercises to the Rehabilitation of Postoperative Hand Injuries in Young Adult Patients. Hand (N Y). 2025 Jul;20(5):778-784. doi: 10.1177/15589447241232017. Epub 2024 Feb 15.

    PMID: 38357889BACKGROUND
  • Winiarski LM, Livoni JD, Madsen PV, Rathleff MS, Larsen P. Concurrent musculoskeletal complaints in elbows, shoulders, and necks after common hand and forearm injuries or conditions: A cross-sectional study among 600 patients. J Hand Ther. 2021 Oct-Dec;34(4):543-548. doi: 10.1016/j.jht.2020.05.002. Epub 2020 Sep 4.

    PMID: 32893097BACKGROUND
  • Horsley I, Herrington L, Hoyle R, Prescott E, Bellamy N. Do changes in hand grip strength correlate with shoulder rotator cuff function? Shoulder Elbow. 2016 Apr;8(2):124-9. doi: 10.1177/1758573215626103. Epub 2016 Jan 25.

    PMID: 27583010BACKGROUND
  • Xue R, Wong J, Imere A, King H, Clegg P, Cartmell S. Current clinical opinion on surgical approaches and rehabilitation of hand flexor tendon injury-a questionnaire study. Front Med Technol. 2024 Feb 15;6:1269861. doi: 10.3389/fmedt.2024.1269861. eCollection 2024.

    PMID: 38425421BACKGROUND
  • Jha CK, Shukla Y, Mukherjee R, Rathva P, Joshi M, Jain D. A Glove-Based Virtual Hand Rehabilitation System for Patients With Post-Traumatic Hand Injuries. IEEE Trans Biomed Eng. 2024 Jul;71(7):2033-2041. doi: 10.1109/TBME.2024.3360888. Epub 2024 Jun 19.

    PMID: 38294922BACKGROUND

MeSH Terms

Conditions

Hand InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nadide Koca, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 20, 2025

Study Start

November 11, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations