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

NCT05530005 | Unknown DMC

• 1 other identifier: SKE01-11/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

subacromial bursa; impingement syndrome

Outcome Measures

Primary Outcomes (8)

• 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

  3 month of observation

• 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

  3 month of observation

• Palpation.

  The examination is carried out in a sitting position with the upper limb suspended.

  3 month of observation

• 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.

  3 month of observation

• 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

  3 month of observation

• 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"

  3 month of observation

• Assessment of pulse on the radial artery

  Examination is performed to exclude the syndrome stealing of the subclavian artery

  3 month of observation

• 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.

  3 month of observation

Study Arms (2)

Hands on

ACTIVE COMPARATOR

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.

Other: Manual Therapy

Hands off

NO INTERVENTION

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.

Interventions

Manual Therapy OTHER

Manual Therapy according to Kaltenborn Evjenth method. Exercises with PT resistance, massage.

Hands on

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klinika Ruchu: lead
• Józef Piłsudski University of Physical Education: collaborator

Study Sites (1)

Klinika Ruchu

Warsaw, Masovian Voivodeship, 02654, Poland

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Andrzej Kepczynski

  Klinika Ruchu

  STUDY DIRECTOR

Central Study Contacts

Andrzej Kepczynski

CONTACT

+48663663383; andrzej.kepczynski@klinikaruchu.pl

Aleksandra Truszczynska

CONTACT

228340431; aleksandra.truszczynska@awf.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: September 7, 2022
• Study Start: June 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: December 3, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-08

Locations

PL (1)