Clinical trial NCT05530005: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: subacromial bursa
impingement syndrome
Lead sponsor: Klinika Ruchu
Sponsor class: OTHER
Collaborators: name: Józef Piłsudski University of Physical Education
First posted: 2022-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ultrasound examination
timeFrame: 3 month of observation
measure: Neer test
timeFrame: 3 month of observation
measure: Palpation.
timeFrame: 3 month of observation
measure: Shoulder joint mobility according to FMS
timeFrame: 3 month of observation
measure: Cross-body abduction stress test
timeFrame: 3 month of observation
measure: The numerical scale of pain level 0-10
timeFrame: 3 month of observation
measure: Assessment of pulse on the radial artery
timeFrame: 3 month of observation
measure: DASH Questionnaire
timeFrame: 3 month of observation
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Klinika Ruchu
state: Mazowieckie
Study officials:
affiliation: Klinika Ruchu
name: Andrzej Kepczynski
role: STUDY_DIRECTOR
References: