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

NCT ID: NCT05530005

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-03

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?

1. 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?

2. 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:

1. ultrasound diagnostics,

2. Neer test,

3. 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.

Conditions

Subacromial Impingement Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hands on

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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy

Intervention Type: OTHER

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

Hands off

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manual Therapy

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Józef Piłsudski University of Physical Education

OTHER

Sponsor Role: collaborator

Klinika Ruchu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrzej Kepczynski

Role: STUDY_DIRECTOR

Klinika Ruchu

Locations

Klinika Ruchu

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Andrzej Kepczynski

Role: CONTACT

andrzej.kepczynski@klinikaruchu.pl

+48663663383

Aleksandra Truszczynska

Role: CONTACT

aleksandra.truszczynska@awf.edu.pl

228340431 ext. 503

Facility Contacts

andrzej krzysztof Kepczynski, Msc

Role: primary

andrzej.kepczynski@klinikaruchu.pl

+48663663383

Other Identifiers

SKE01-11/2022

Identifier Type: -

Identifier Source: org_study_id