NCT06602206

Brief Summary

Patients who come to Tavşanlı State Hospital's Physical Therapy and Rehabilitation Department and have been diagnosed with subacromial impingement syndrome by a physician will be included. Patients will be selected by randomization method among the patients determined by the physician to receive conservative treatment, shoulder mobilization in addition to conservative treatment, and neck mobilization treatment program in addition to these. Conventional treatments such as hot packs, TENS, ultrasound, and exercise will be given to all patients by the hospital staff. Pain intensity will be evaluated with VAS. Additionally, painful arch and pain-free joint range of motion evaluation will be made using a goniometer. The DASH questionnaire will be used to evaluate shoulder functionality. Sensory evaluation will be made with pressure pain threshold and two-point discrimination tests. Measurements will be made before the intervention and repeated after 3 weeks of intervention.

Trial Health

77
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
4mo left

Started Oct 2024

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress83%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

July 30, 2024

Last Update Submit

October 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity will be evaluated with VAS. VAS is a valid and reliable self-report scale consisting of a 10 cm long horizontal line, with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to report the maximum pain they experienced in the last 24 hours. A change of 1.5 points is considered a minimal clinically important difference (MCID) for the VAS.

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • The Arm, Shoulder and Hand Problems (DASH) Questionnaire

    through study completion, an average of 1 year

  • Painful arch assessment

    through study completion, an average of 1 year

  • Painless range of motion assessment

    through study completion, an average of 1 year

  • Pressure-pain Threshold Assessment

    through study completion, an average of 1 year

  • Evaluation of Tactile Sensory Acuity

    through study completion, an average of 1 year

Study Arms (3)

Conventional treatment group

ACTIVE COMPARATOR

Hot packs, TENS, ultrasound, and exercise

Other: Conventional Treatment

Conventional treatment + shoulder mobilization group

EXPERIMENTAL

Hot packs, TENS, ultrasound, exercise, and shoulder mobilization

Other: Conventional TreatmentOther: shoulder mobilization

Conventional treatment + shoulder mobilization + neck mobilization group

EXPERIMENTAL

Hot packs, TENS, ultrasound, exercise, and shoulder and neck mobilization

Other: Conventional TreatmentOther: shoulder mobilizationOther: neck mobilization

Interventions

Hot pack,TENS, ultrasound and exercises

Conventional treatment + shoulder mobilization + neck mobilization groupConventional treatment + shoulder mobilization groupConventional treatment group

In the glenohumeral joint mobilization technique, distraction, anterior-posterior gliding, and inferior gliding movements will be applied.

Conventional treatment + shoulder mobilization + neck mobilization groupConventional treatment + shoulder mobilization group

Bridge, lateral flexion movement combined with traction, anterior-posterior gliding with traction, and lateral gliding techniques will be applied in neck mobilization.

Conventional treatment + shoulder mobilization + neck mobilization group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age
  • Diagnosed with Subacromial Impingement
  • Not having received any treatment for shoulder problems in the last 6 months
  • The pain has been continuing for 3 months
  • Initial pain must be 4 or higher on the Visual Analog Scale (VAS)

You may not qualify if:

  • History of surgery in the shoulder, cervical and thoracic region
  • Having a shoulder problem such as a frozen shoulder or instability
  • Full-thickness rotator cuff tear
  • Having systemic musculoskeletal disease
  • Having systemic rheumatic disease
  • History of upper extremity fracture
  • Diagnosed with scoliosis
  • Have neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Meltem Işıntaş

    Kutahya Health Sciences University

    STUDY DIRECTOR

Central Study Contacts

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

July 30, 2024

First Posted

September 19, 2024

Study Start

October 7, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations