NCT07568340

Brief Summary

This randomized controlled trial aims to compare the effectiveness of physiotherapist-supervised rehabilitation and home exercise programs in individuals with subacromial impingement syndrome (SAIS). SAIS is a common musculoskeletal disorder characterized by shoulder pain, reduced range of motion, and functional limitations, negatively affecting quality of life. Participants diagnosed with SAIS will be randomly assigned to one of three groups: a supervised rehabilitation group, a home exercise group, or a control group. Randomization will be performed using an online randomization tool. Individuals in the supervised rehabilitation group will receive a structured physiotherapy program administered by a physiotherapist, while those in the home exercise group will perform a standardized exercise program at home following initial instruction. Participants in the control group will not receive any intervention during the study period and will be assessed only. Outcome measures including pain intensity, upper extremity function, range of motion, grip strength, sleep quality, and quality of life will be evaluated at baseline and after the intervention period. The results of this study are expected to provide evidence regarding the comparative effectiveness of supervised and home-based exercise approaches in the management of SAIS.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Dec 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 2, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Pain intensity will be assessed using the Visual Analog Scale during rest, activity, and night pain. Higher scores indicate greater pain severity.

    Baseline and after 4 weeks

Secondary Outcomes (5)

  • Upper Extremity Function

    Baseline and after 4 weeks

  • Shoulder Range of Motion

    Baseline and after 4 weeks

  • Grip Strength

    Baseline and after 4 weeks

  • Sleep Quality

    Baseline and after 4 weeks

  • Quality of Life-WHOQOL-BREF

    Baseline and after 4 weeks

Study Arms (3)

Supervised Rehabilitation

EXPERIMENTAL

Participants in this group will receive a physiotherapist-supervised rehabilitation program five days per week for four weeks. The program will include pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training according to standard physiotherapy procedures.

Behavioral: Supervised Rehabilitation Program

Home Exercise Program

EXPERIMENTAL

Participants in this group will receive a structured home exercise program after an education session. The program will include stretching, range of motion, scapular stabilization, and strengthening exercises to be performed independently at home for four weeks.

Behavioral: Home Exercise Program

Control

NO INTERVENTION

Participants in this group will not receive any intervention during the four-week study period. Baseline and follow-up assessments will be performed. Individuals who are required to wait more than four weeks before starting physiotherapy sessions will be included in this group.

Interventions

A structured home exercise program including stretching, range of motion, scapular stabilization, and strengthening exercises performed independently at home for four weeks following an education session.

Home Exercise Program

A physiotherapist-supervised rehabilitation program including pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training administered five days per week for four weeks.

Supervised Rehabilitation

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation in the study
  • Literate in Turkish
  • Aged between 30 and 65 years
  • No visual or hearing impairment
  • Diagnosed with unilateral subacromial impingement syndrome by a specialist physician
  • Positive painful arc test, Infraspinatus test, and Hawkins-Kennedy test
  • Pain during overhead activities

You may not qualify if:

  • Presence of a mental or psychological disorder that may affect study findings
  • Inadequate cooperation
  • History of upper extremity fracture within the last 6 months
  • Presence of cervical neurological symptoms
  • Glenohumeral instability
  • Acromioclavicular joint pathology
  • Full-thickness rotator cuff tear or total rupture
  • Signs of glenohumeral osteoarthritis
  • History of frozen shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırsehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Gutierrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Alvarez-Bueno C, Martinez-Vizcaino V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis. Phys Ther Sport. 2020 Jan;41:34-42. doi: 10.1016/j.ptsp.2019.11.003. Epub 2019 Nov 6.

  • Diercks R, Bron C, Dorrestijn O, Meskers C, Naber R, de Ruiter T, Willems J, Winters J, van der Woude HJ; Dutch Orthopaedic Association. Guideline for diagnosis and treatment of subacromial pain syndrome: a multidisciplinary review by the Dutch Orthopaedic Association. Acta Orthop. 2014 Jun;85(3):314-22. doi: 10.3109/17453674.2014.920991. Epub 2014 May 21.

  • Horowitz EH, Aibinder WR. Shoulder Impingement Syndrome. Phys Med Rehabil Clin N Am. 2023 May;34(2):311-334. doi: 10.1016/j.pmr.2022.12.001. Epub 2023 Feb 26.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

December 2, 2025

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations