NCT05402709

Brief Summary

Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability and reduced quality of life. This study was designed to investigate the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

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 Start

First participant enrolled

December 26, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

May 28, 2022

Last Update Submit

November 2, 2022

Conditions

Keywords

subacromial impingement syndromeposterior capsulemobilisation

Outcome Measures

Primary Outcomes (9)

  • Assessment of Joint Range of Motion

    Shoulder flexion, abduction, external and internal rotations were evaluated actively and passively using a classical goniometer (Santa Pharma 12 inch) while the patient was in the supine position. Measurements were made twice, before and at the end of the treatment (6th week), and the average value was taken bilaterally three times.

    6 weeks

  • Assessment of Muscle Strength

    "JTech Commander Power Track IITM" Myometer device was used for muscle strength evaluation. In the evaluation, shoulder flexion, extension, abduction, internal and external rotation movements were held with resistance for 3-5 seconds for each movement (according to the manual muscle test rules). Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times, and the average values were taken and tested by the physiotherapist.

    6 weeks

  • Assessment of Grip Strength

    The grip strength of the hand was evaluated using the "JTech Commander Grip Track Hand Dynamometer". The patient was evaluated by the physiotherapist in a sitting position in a chair, with the shoulder to be tested in adduction and neutral rotation, the elbow in 90 degree flexion, and the forearm and wrist in neutral position. The patients were asked to squeeze the dynamometer as hard as possible. After a 30-second rest break between measurements, the next measurement was started. Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times and evaluated by taking the average values.

    6 weeks

  • Assessment of Pain

    The pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) by the physiotherapist. The Visual Analogue Scale is a scale in which evaluation is made on a 10 cm line drawn on the horizontal plane with a maximum of 10 and a minimum of 0 points. The patient was asked to mark the severity of the pain he felt in his shoulder on this line, and the pain before and after the treatment was evaluated with this method.

    6 weeks

  • American Shoulder and Elbow Surgeons Assessment Form

    The American Shoulder and Elbow Surgeons Assessment Form (ASES) is a standard shoulder evaluation form that evaluates pain and function in the upper extremity, including objective and subjective parts, prepared by shoulder and elbow surgeons. The questionnaire consists of pain (VAS) and function (10 questions). The function section consists of a 4-point Likert scale for each question. The Turkish version of ASES was used in the study, the validity and reliability of which were made by Çelik et al. in 2012. The total score of the questionnaire completed by the patients before and after the treatment was evaluated out of 100.

    6 weeks

  • Quick-DASH

    The Arm, Shoulder and Hand Problems Questionnaire (Quick-DASH) is a scale that evaluates the disability and health status of the upper extremity, which can be filled by the individual alone. The questionnaire consists of 11 questions, each of which evaluates problems such as whether the patient has limitations in activities that require upper extremity functions in daily life activities, the effect of the current problem on the person's social activities, pain, tingling sensation and difficulty in sleeping, and a business model with 4 questions each, and sports that require high performance. The questions do not only address the shoulder area, but also cover the hand and arm. Scoring takes a value between 0-100 and a high score reflects more disability. In our study, we made use of the website while performing the Quick-DASH scoring. People with Subacromial Impingement Syndrome completed this questionnaire at the beginning and end of treatment.

    6 weeks

  • Modified Constant-Murley Score (CMS)

    Constant Murley Score (CMS), the first shoulder scoring system developed, was put into effect in 1987 by Constant and Murley. This questionnaire, which is used to evaluate various diseases of the shoulder; pain, activities of daily living, strength and range of motion are evaluated qualitatively and quantitatively. The CMS consists of pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points) subscales. The difference of the modified CMS from the original CMS; While the VAS was used for the pain scale in the modified CMS, the pain was rated as "severe", "moderate", "mild", and "absent" in the original. Modified CMS is scored over 100 points. A higher score indicates higher quality of functionality. We also used the Turkish version of Modified Constant-Murley Score at the beginning and end of the treatment in our study.

    6 weeks

  • Cornell Musculoskeletal Discomfort Questionnaire

    The Cornell Musculoskeletal Discomfort Questionnaire is a data collection tool developed at the Human Factors and Ergonomics Laboratory at Cornell University and used to evaluate musculoskeletal problems. The Cornell Musculoskeletal Disorders Questionnaire includes questions such as the frequency and severity of musculoskeletal disorders and whether these disorders interfere with work, over 10 upper extremity body regions on 3 separated scales. In our study, the Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire was used, and it was filled in by the patients at the beginning and end of the treatment.

    6 weeks

  • Assessment of Posterior Capsule Tightness

    The medial epicondyle of the tested arm is marked with a pencil and aligned with the subject's acromion perpendicular to the treatment table with the spine in a neutral position. By stabilizing the lateral border of the scapula while the shoulder is in the retracted position, scapular movement is restricted and the subject's humerus is positioned at 90° horizontal abduction, 0° rotation at the start of the test.

    6 weeks

Study Arms (3)

Posterior mobilization group

ACTIVE COMPARATOR

Posterior mobilization, classical stretching, strengthening exercises were applied and home exercise program were given

Other: Posterior mobilisation technique

Posterior capsule stretching

ACTIVE COMPARATOR

Posterior capsule stretching, classical stretching, strengthening exercises were applied and home exercise program were given

Other: Posterior capsule stretching

Control group

NO INTERVENTION

No treatment was given, only assessment of posterior capsule tightness was applied.

Interventions

Posterior mobilisation technique were applied

Posterior mobilization group

Posterior capsule stretching were applied

Posterior capsule stretching

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between 30-60 years old
  • Positive Neer, Hawkins-Kennedy impingement tests
  • Painful arch and minimal limitation during active flexion and abduction movements in the glenohumeral joint area or proximal arm
  • Symptoms lasting longer than 1 month

You may not qualify if:

  • Adhesive capsulitis,
  • Rotator cuff tears,
  • Calcific tendinitis findings in radiology,
  • Having a heart disease
  • Presence of neurological diseases,
  • Cognitive and mental problems that will affect understanding,
  • Cervical radiculopathies,
  • Presence of inflammatory joint diseases,
  • Surgical intervention on the same shoulder in the last 12 months,
  • To have had physical therapy on the same shoulder in the last 3 months,
  • Presence of instability or previous dislocation history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Model Details: Individuals were randomly divided into 3 different groups as posterior mobilisation, posterior capsule stretching and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 28, 2022

First Posted

June 2, 2022

Study Start

December 26, 2016

Primary Completion

February 8, 2017

Study Completion

June 25, 2017

Last Updated

November 8, 2022

Record last verified: 2022-11