CClinicalTrials.gg
Status unknownNCT05530005Updated Sep 7, 2022

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

An interventional study of Manual Therapy in Subacromial Impingement Syndrome, sponsored by Klinika Ruchu. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Klinika Ruchu · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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,
  1. 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.
02

Conditions studied

  • Subacromial Impingement Syndrome

Keywords

  • subacromial bursa
  • impingement syndrome
03

In context

Shoulder Impingement Syndrome

304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.

This study's planned enrollment of 60 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

This is the only study on the registry with Klinika Ruchu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Manual Therapy

  • No intervention
    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.

Interventions

  • OtherManual Therapy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 month of observation

  2. 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

    Time frame: 3 month of observation

  3. Palpation.

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

    Time frame: 3 month of observation

  4. 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.

    Time frame: 3 month of observation

  5. 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

    Time frame: 3 month of observation

  6. 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"

    Time frame: 3 month of observation

  7. Assessment of pulse on the radial artery

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

    Time frame: 3 month of observation

  8. 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.

    Time frame: 3 month of observation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05530005
Lead sponsor
Klinika Ruchu
Collaborators
Józef Piłsudski University of Physical Education
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
Jun 1, 2022
Primary completion
Jul 30, 2022
Completion
Dec 3, 2023 (estimated)
Last update
Sep 7, 2022

Study contacts

Andrzej Kepczynski
Contact
andrzej.kepczynski@klinikaruchu.pl
+48663663383
Aleksandra Truszczynska
Contact
aleksandra.truszczynska@awf.edu.pl
228340431 ext. 503
Andrzej Kepczynski
study director · Klinika Ruchu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion