- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07601568
Pectoralis Minor Release in Patients With Subacromial Impingement Syndrome
Efficacy of Pectoralis Minor Release on Subacromial Space in Patients With Subacromial Impingement Syndrome
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Statement of the problem:
This study will be designed to answer the following question Does PMI release have an effect on subacromial space in patients with SAIS?
The purposes of the study:
- To investigate the effect of PMI release on subacromial space in patients with SAIS.
- To investigate the effect of PMI release on pectoralis minor length in patients with SAIS.
- To investigate the effect of PMI release on shoulders ROM (flexion, abduction, internal and external rotation) in patients with SAIS.
- To investigate the effect of PMI release on shoulder joint pain in patients with SAIS.
- To investigate the effect of PMI release on functional ability in patients with SAIS.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Dokki
-
Giza, Dokki, Egypt, 12612
- Faculty of Physical Therapy Cairo University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients with chronic unilateral SAIS.
- Patient age average 40- 60 years old from both sexes (Michael and Gail 2000).
- Decreased AHD less than 10mm by x-ray image (Mean AHD in absence of rotator cuff tear is 10.5mm (Goutallier et al., 2011)).
- Decreased of active shoulder ROM.
- Presence of unilateral shoulder joint pain.
- Reliable patients.
Exclusion Criteria:
All patients who have any of the following will be excluded from the study (Lewis and Valentine 2007)
- Intra articular injection.
- Arthroscopic intervention.
- Previous shoulder fracture.
- Shoulder subluxation.
- Adhesive capsulitis.
- Shoulder osteoarthritis.
- Any previous operation on cervical and shoulder region.
- Mastectomy on the same side of shoulder impingement.
- Patients with neurological disorder that may contribute performance the procedure instructions.
- Osteoporosis.
- Pregnant and lactating woman.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Sham-komparator: traditional group
Thirty patients will receive traditional physical therapy treatment (Postural correction exercises and scapular stabilization exercises) at the painful shoulder, Treatment sessions will be two times per week for six weeks
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Physiotherapy treatment included passive manual joint mobilization, home-based strengthening exercises and advice on posture, twice a week. So, we will apply this conventional physical therapy to control group
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Eksperimentell: Experimental Group
Thirty patients will receive traditional treatment plus pectoralis minor stretching and release, Treatment sessions will be two times per week for six weeks.
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Physiotherapy treatment included passive manual joint mobilization, home-based strengthening exercises and advice on posture, twice a week. So, we will apply this conventional physical therapy to control group
Treatment will be conventional treatment with pectoralis minor release and stretch.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Subacromial space will be measured by X-ray image
Tidsramme: 6 months
|
The radiograph will be done to measure acromio-humeral distance, which is considered the shortest distance between the inferior cortex of acromion and the top of humeral head.
In normal shoulders, the sub acromial space was between 9 and 10 mm.
The space was significantly greater in men, with a slight reduction with age.
In middle age, a sub-acromial space less than 6 mm is pathological
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pectoralis minor length will be measured by tape measurement
Tidsramme: 6 month
|
Participants will be asked to remain in a relaxed posture with the arms at the side in a neutral position, avoid postural correction, and exhale just before the measurement. A tape measure was used to measure the linear distance between the origin and insertion of the muscle. The primary investigator of the study performed all measurements. The origin was defined as the inferior aspect of the 4th rib, which was one finger width lateral to the sternum, just lateral to the sternocostal junction. The insertion was defined as the medial-inferior aspect of the coracoid process . |
6 month
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Shoulder joint ROM (flexion, abduction, internal and external rotation) will be measured by inclinometer
Tidsramme: 6 month
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Shoulder flexion, abduction, internal and external rotation movements will be measured with the individual seated upright on a non-reclining high-back chair, to limit trunk compensation. The chair was the same for all movements performed by one individual, but different for each individual, to provide support up to the middle of the scapula. Shoulder movements will be actively and passively evaluated for flexion in supine and seated positions, abduction, external rotation in a neutral position with 0° abduction (ERN), external rotation with the arm at 90° of abduction (ER90), and internal rotation with the arm at 90° of abduction (IR90) using an Acumar digital inclinometer . |
6 month
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Pain intensity will be measured by using VAS ( visual analog scale)
Tidsramme: 6 month
|
The patients' pain severity will be evaluated using a visual analog scale (VAS).
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain
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6 month
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Identification of Functional Ability of the shoulder joint using Q-DASH questionnaire with Arabic version
Tidsramme: 6 month
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The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper extremity disability and symptoms The use of the DASH questionnaire as an outcomes instrument in patients with upper-extremity complaints.
The main part of the Quick-DASH is a 14-item disability/symptom scale concerning the patient's health status during the preceding week.
The items ask about the degree of difficulty in performing different physical activities as well as the problem's impact on social activities, work, sleep, and self-image.
Each item has five response options.
The scores for all items are then used to calculate a scale score ranging from 1 (no difficulty) to 5 ( unable).
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6 month
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Abu EL Kasem Sh., Alaa F., Abd EL-Raoof N. et al., (2024):" Efficacy of Mulligan thoracic sustained natural apophyseal glides on sub-acromial pain in patients with sub-acromial impingement syndrome: a single-blinded randomized controlled trial "journal of manual & manipulative therapy 10.1080/10669817.2024.2341453 Amado A., Marques A., Maiorino R. et al., (2006):" An Anatomical Study of The Subcoracoid Space" CLINICS 2006;61(5):467-72 Ann Sisto S. and Dyson-Hudson T. (2007):" Dynamometry testing in spinal cord injury" Journal of Rehabilitation Research & Development, Volume 44, Number 1 Anne T., Herrington L., Horlsey I. et al. (2015):" An evidence-based review of current perceptions with regard to the subacromial space in shoulder impingement syndromes: Is it important and what influences it?" Clinical Biomechanics , Volume 30, Issue 7, August 2015, Pages 641-648
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/005809
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