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Traditional Physiotherapy Protocol vs Prescribed Exercises in Impingement Syndrome of the Shoulder

Primary Purpose

Subacromial Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
Klinika Ruchu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring subacromial bursa, impingement syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-5 0 years,

    • shoulder pain lasting from 3 months to 1 year,
    • no surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease.
    • ailments in scales I and II according to Neer.

Exclusion Criteria:

  • surgical procedures and other surgical interventions
  • features of the total rupture of the rotator cuff muscle- III⁰ according to Neer scale, confirmed in imaging studies.
  • age under 25 or over 50 years
  • diagnosed in ultrasound or MRI with complete damage to the muscles of the rotator cuff,
  • the duration of the ailment is up to 3 months or more than 1 year.

Sites / Locations

  • Klinika RuchuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hands on

Hands off

Arm Description

Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer.

Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer.

Outcomes

Primary Outcome Measures

Ultrasound examination
The measurement will be carried out on one ultrasound device. In all patients, a measurement of the subscapular space of the shoulder joint in the ultrasound image will be performed. Ultrasound examinations are used in the diagnosis of the shoulder joint to assess the thickness and quality of tendons and recognized them. Examinations will take place in the positions: of the suspended upper limb and in the position of visit and external rotation in the shoulder joint. Putting on the Power Doppler mesh will allow you to exclude visible inflammation of the examined area while excluding ongoing acute inflammation. In case of doubt or when the examination shows acute inflammation, the patient will be referred to a doctor and a specialist. The measurement will be carried out on one ultrasound device - Siemens Acuson X150, 10-5 MHz linear fisheries. , by one experienced physiotherapist in accordance with the guidelines
Neer test
Performing the test: the subject sits sideways to the examiner, the upper c. of the subject with a bent elbow joint and a bent and brought shoulder joint. The examiner resists the subject's elbow from above, who slightly presses his elbow on the investigator's hand. Results: + pain appears in the test position or after pressure, - no pain, +/- the subject is not able to assess the pain
Palpation.
The examination is carried out in a sitting position with the upper limb suspended.
Shoulder joint mobility according to FMS
The test evaluates the bilateral mobility of the entire shoulder girdle. The test evaluates the bilateral mobility of the entire shoulder girdle, combining internal rotation with arrival and external rotation with visitation. Proper mobility also requires mobility in the shoulder-scapular joint and in the thoracic spine.
Cross-body abduction stress test
The subject sits with a limb bent to 90⁰ in the shoulder and elbow joint. Performs the movement of horizontal attachment in the shoulder joint
The numerical scale of pain level 0-10
The patient is asked to determine the level of pain on a scale of 0-10. The subject is asked to determine the level of pain on a scale of 0-10, in which it is determined how severe the pain is, indicating the appropriate digit on a scale from 0 to 10, where 0 corresponds - "I do not feel pain at all", - 10 - "the worst pain I can imagine"
Assessment of pulse on the radial artery
Examination is performed to exclude the syndrome stealing of the subclavian artery
DASH Questionnaire
The questionnaire is concerning upper limb disability. The subject assesses his ability to perform the following actions last week by outlining the number of the most accurate answer in Table 1. The subject then assesses the severity of symptoms last week by outlining the number in Table 2 of the most accurate answer. After completing the test, we count the sum of points. DASH Limitations and Symptoms Index = -1)]×25 where: n = numbers of the answers given. If more than three questions are left unanswered, the DASH cannot be calculated.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
September 2, 2022
Sponsor
Klinika Ruchu
Collaborators
Józef Piłsudski University of Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05530005
Brief Title
Traditional Physiotherapy Protocol vs Prescribed Exercises in Impingement Syndrome of the Shoulder
Official Title
Comparison of the Traditional Physiotherapy Protocol With Monitoring Individually Prescribed Exercises in Impingement Syndrome of the Shoulder Joint
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
December 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klinika Ruchu
Collaborators
Józef Piłsudski University of Physical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pain and limitation of shoulder mobility resulting from sub-shoulder syndrome called sub acromion impingement syndrome (SIS) are a big social problem in highly developed countries. This work aims to compare the method of treating SIS ailments taking into account the monitored exercises on their own- hands off, to the traditional method of individual physiotherapy considering manual therapy, TENS and local cryotherapy- hands on. The study will qualify people aged 18-50 years without previous injections, surgical procedures and physiotherapy within the shoulder joint. The initial examination of the participants will include: ultrasound examination, Neer test, functional mobility test according to FMS, clinical examination: palpation of the joint area, cross body adduction test, radial artery pulse test, numerical pain scale 0-10, DASH questionnaire. After the initial checkups, 60 people will be qualified for the proper examination. Selected participants will be divided into two groups of 30 people, each group consisting of 15 women and 15 men. The first group will undergo self-therapy for 3-5 months. The subjects will exercise independently for about 1.5 hours a day, three times a week. Every two weeks, each subject will be admitted to a follow-up visit, during which the physiotherapist will recommend another set of exercises and check the progress. The second group will undergo traditional physiotherapy three times a week for a period of three months. After a period of 3-5 months, both groups will undergo the same examination as initially. The results of both studies will be compared in both groups. The groups will then be compared to each other.
Detailed Description
The aim of the study is to compare the effectiveness of individual physiotherapy, using manual therapy, exercises conducted individually and physical therapy to therapy assuming recommendations for self-performed exercises in accordance with the physiotherapist's recommendations. Research questions? Will the effects of self-directed physiotherapy be comparable in terms of reducing pain, improving range of motion, function, and quality of life, and helping reduce the cost of therapy compared to physiotherapy in constant contact? Will the results of subacromial space measurements in ultrasound examination in both groups before and after therapy correlate with clinical and functional tests? The duration of the intervention is assumed at one year. The study will last 3 months. About 60 people will be included in the study, who will be divided into 2 groups, about 30 people each (30 men and 30 women). Patients will be aged 18-50 years. The choice of the group will depend on where the patient comes forward. Patients who report to the Klinika Ruchu will be conducted with individual outpatient physiotherapy - "hands-on". Patients who apply to the Zdrowe Miejsce will be guided by therapy through self-practice "hands off". The study of patients will include: ultrasound diagnostics, Neer test, palpation of the joint area, taking into account the assessment of the condition of the rotator cuff muscles and muscle around the scapula to exclude possible pronounced atrophy, which may indicate damage to the nerve roots from the C5-6 level, sometimes 7- Erb damage, 3. tests of shoulder mobility according to FMS, 4. cross body abduction stress test to exclude changes in the shoulder-clavicle joint, 5. numerical scale of pain level 0-10, 6. assessment of the pulse on the radial artery in order to exclude damage to the subclavian artery, 7. tension tests of long nerves of the upper kk, 8. DASH Upper Limb Disability Questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
subacromial bursa, impingement syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hands on
Arm Type
Active Comparator
Arm Description
Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer.
Arm Title
Hands off
Arm Type
No Intervention
Arm Description
Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Manual Therapy according to Kaltenborn Evjenth method. Exercises with PT resistance, massage.
Primary Outcome Measure Information:
Title
Ultrasound examination
Description
The measurement will be carried out on one ultrasound device. In all patients, a measurement of the subscapular space of the shoulder joint in the ultrasound image will be performed. Ultrasound examinations are used in the diagnosis of the shoulder joint to assess the thickness and quality of tendons and recognized them. Examinations will take place in the positions: of the suspended upper limb and in the position of visit and external rotation in the shoulder joint. Putting on the Power Doppler mesh will allow you to exclude visible inflammation of the examined area while excluding ongoing acute inflammation. In case of doubt or when the examination shows acute inflammation, the patient will be referred to a doctor and a specialist. The measurement will be carried out on one ultrasound device - Siemens Acuson X150, 10-5 MHz linear fisheries. , by one experienced physiotherapist in accordance with the guidelines
Time Frame
3 month of observation
Title
Neer test
Description
Performing the test: the subject sits sideways to the examiner, the upper c. of the subject with a bent elbow joint and a bent and brought shoulder joint. The examiner resists the subject's elbow from above, who slightly presses his elbow on the investigator's hand. Results: + pain appears in the test position or after pressure, - no pain, +/- the subject is not able to assess the pain
Time Frame
3 month of observation
Title
Palpation.
Description
The examination is carried out in a sitting position with the upper limb suspended.
Time Frame
3 month of observation
Title
Shoulder joint mobility according to FMS
Description
The test evaluates the bilateral mobility of the entire shoulder girdle. The test evaluates the bilateral mobility of the entire shoulder girdle, combining internal rotation with arrival and external rotation with visitation. Proper mobility also requires mobility in the shoulder-scapular joint and in the thoracic spine.
Time Frame
3 month of observation
Title
Cross-body abduction stress test
Description
The subject sits with a limb bent to 90⁰ in the shoulder and elbow joint. Performs the movement of horizontal attachment in the shoulder joint
Time Frame
3 month of observation
Title
The numerical scale of pain level 0-10
Description
The patient is asked to determine the level of pain on a scale of 0-10. The subject is asked to determine the level of pain on a scale of 0-10, in which it is determined how severe the pain is, indicating the appropriate digit on a scale from 0 to 10, where 0 corresponds - "I do not feel pain at all", - 10 - "the worst pain I can imagine"
Time Frame
3 month of observation
Title
Assessment of pulse on the radial artery
Description
Examination is performed to exclude the syndrome stealing of the subclavian artery
Time Frame
3 month of observation
Title
DASH Questionnaire
Description
The questionnaire is concerning upper limb disability. The subject assesses his ability to perform the following actions last week by outlining the number of the most accurate answer in Table 1. The subject then assesses the severity of symptoms last week by outlining the number in Table 2 of the most accurate answer. After completing the test, we count the sum of points. DASH Limitations and Symptoms Index = -1)]×25 where: n = numbers of the answers given. If more than three questions are left unanswered, the DASH cannot be calculated.
Time Frame
3 month of observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-5 0 years, shoulder pain lasting from 3 months to 1 year, no surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. ailments in scales I and II according to Neer. Exclusion Criteria: surgical procedures and other surgical interventions features of the total rupture of the rotator cuff muscle- III⁰ according to Neer scale, confirmed in imaging studies. age under 25 or over 50 years diagnosed in ultrasound or MRI with complete damage to the muscles of the rotator cuff, the duration of the ailment is up to 3 months or more than 1 year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Kepczynski
Phone
+48663663383
Email
andrzej.kepczynski@klinikaruchu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Truszczynska
Phone
228340431
Ext
503
Email
aleksandra.truszczynska@awf.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Kepczynski
Organizational Affiliation
Klinika Ruchu
Official's Role
Study Director
Facility Information:
Facility Name
Klinika Ruchu
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02654
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
andrzej krzysztof Kepczynski, Msc
Phone
+48663663383
Email
andrzej.kepczynski@klinikaruchu.pl

12. IPD Sharing Statement

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Traditional Physiotherapy Protocol vs Prescribed Exercises in Impingement Syndrome of the Shoulder

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