Shoulder and Neck Mobilization in Patients With Subacromial Impingement Syndrome

Effects of Shoulder and Neck Mobilization on Pain, Sensation and Functionality in Patients With Subacromial Impingement Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: Conventional Treatment; Other: shoulder mobilization; Other: neck mobilization

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Işıntaş; Phone Number: +902742652031; Email: meltem.isintas@ksbu.edu.tr

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • Recruiting
    • Kütahya Health Sciences University
    • Contact: Meltem B Işıntaş; Phone Number: 05303438828; Email: meltem.isintas@ksbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment group; Hot packs, TENS, ultrasound, and exercise	Other: Conventional Treatment; Hot pack,TENS, ultrasound and exercises
Experimental: Conventional treatment + shoulder mobilization group; Hot packs, TENS, ultrasound, exercise, and shoulder mobilization	Other: Conventional Treatment; Hot pack,TENS, ultrasound and exercises; Other: shoulder mobilization; In the glenohumeral joint mobilization technique, distraction, anterior-posterior gliding, and inferior gliding movements will be applied.
Experimental: Conventional treatment + shoulder mobilization + neck mobilization group; Hot packs, TENS, ultrasound, exercise, and shoulder and neck mobilization	Other: Conventional Treatment; Hot pack,TENS, ultrasound and exercises; Other: shoulder mobilization; In the glenohumeral joint mobilization technique, distraction, anterior-posterior gliding, and inferior gliding movements will be applied.; Other: neck mobilization; Bridge, lateral flexion movement combined with traction, anterior-posterior gliding with traction, and lateral gliding techniques will be applied in neck mobilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Arm, Shoulder and Hand Problems (DASH) Questionnaire	(DASH) questionnaire is a questionnaire that evaluates the functional level and disability of the entire upper extremity. At least 27 out of 30 questions must be answered for the inquiry to be evaluated. The query gives a value between 0-100. All questions are scored from 1 to 5. A higher score indicates greater disability.	through study completion, an average of 1 year
Painful arch assessment	The patient is asked to abduct his arm as much as he can while standing or sitting. The test is positive if the patient feels pain between 60-120° of elevation. The sensitivity of the painful arc test performed in CNS patients was found to be 53% and the specificity was 80%.	through study completion, an average of 1 year
Painless range of motion assessment	Painless ROM evaluation will be performed in CNS patients due to the presence of a painful arch. Pain-free ROM evaluation includes flexion and abduction movements occurring in the frontal and sagittal planes. These movements are evaluated using a universal goniometer. The patient is asked to actively create 2 movements in a standing or sitting position. While performing measurements with a goniometer, the part with pain-free ROM will be noted in degrees	through study completion, an average of 1 year
Pressure-pain Threshold Assessment	Pressure pain threshold is the most commonly used method among quantitative sensory tests.Measurements will be taken from the upper trapezius, supraspinatus, and middle deltoideus muscles.	through study completion, an average of 1 year
Evaluation of Tactile Sensory Acuity	Esthesiometer measurements will be taken from the surfaces corresponding to the C5, C6, and C7 dermatomes. To standardize the test areas, vertical lines will be drawn from the anterior, middle, and posterior edges of the acromion towards the elbow. The test will begin at 0 mm and the distance will first be gradually increased in 5 mm increments until the participant perceives two dots instead of one. When the participant reports detecting two dots, that distance will be recorded. Separate evaluations will be taken from 3 regions and the results will be recorded.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Study Director: Meltem Işıntaş, Kütahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 2024/06-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No