Mobilization With Movement in Rotator Cuff Tendinopathy
Effects of Mobilization With Movement on Tendon Morphology, Pain, and Function in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of Mobilization With Movement (MWM) combined with exercise therapy on tendon morphology, pain, and functional outcomes in individuals with rotator cuff tendinopathy. A total of approximately 60 participants diagnosed with supraspinatus tendinopathy will be randomly assigned to either an exercise-only group or an exercise plus MWM group.
All participants will undergo a standardized rehabilitation program for 8 weeks. Clinical outcomes, including pain intensity (Visual Analog Scale), shoulder function (SPADI and QuickDASH), range of motion, muscle strength, proprioception, and psychosocial status (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, and Central Sensitization Inventory), will be assessed at baseline and post-intervention. In addition, ultrasound imaging will be used to evaluate tendon morphology, including tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity.
The primary objective is to determine whether MWM produces superior improvements in clinical outcomes and whether it is associated with measurable changes in tendon structure as assessed by ultrasound. The findings are expected to contribute to a better understanding of the biomechanical and neurophysiological mechanisms underlying manual therapy in rotator cuff tendinopathy and to provide evidence for its role in musculoskeletal rehabilitation.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Rotator cuff tendinopathy is one of the most common causes of shoulder pain and functional limitation, often resulting in reduced quality of life and impaired upper extremity performance. Although exercise therapy is widely accepted as the cornerstone of conservative management, the additional benefit of manual therapy techniques, particularly Mobilization With Movement (MWM), remains an area of ongoing investigation. Furthermore, the potential effects of manual therapy on tendon morphology assessed via ultrasound imaging are not yet fully understood.
This randomized controlled trial will examine whether the addition of MWM to a standardized exercise program provides superior outcomes compared to exercise alone in individuals with supraspinatus tendinopathy. Participants will be randomly allocated into two groups: an exercise-only group and an exercise plus MWM group. Both interventions will be delivered over an 8-week period.
The study will focus on both clinical and imaging-based outcomes. Clinical outcomes include pain intensity, shoulder function, range of motion, muscle strength, proprioception, and psychosocial factors such as fear of movement, pain catastrophizing, and central sensitization. Imaging outcomes will be assessed using musculoskeletal ultrasound to evaluate tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity.
The primary aim is to determine whether MWM induces superior improvements in pain and function and whether these changes are accompanied by measurable alterations in tendon morphology. Secondary aims include exploring the relationship between ultrasound-based structural changes and clinical outcomes, as well as evaluating the potential role of psychosocial factors in treatment response.
This study is expected to provide new evidence regarding the structural and functional effects of manual therapy in rotator cuff tendinopathy and to clarify whether improvements in clinical symptoms are associated with objective changes in tendon morphology.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 18 and 65 years
- Clinical diagnosis of rotator cuff tendinopathy (supraspinatus involvement) confirmed by musculoskeletal ultrasound
- Shoulder pain duration of at least 3 months
- Pain intensity ≥ 3/10 on the Visual Analog Scale (VAS)
- Ability to understand and follow instructions and complete questionnaires
Exclusion Criteria:
- Full-thickness or large rotator cuff tear confirmed by ultrasound or MRI
- History of shoulder surgery on the affected side
- Diagnosis of adhesive capsulitis (frozen shoulder)
- Shoulder instability or dislocation history
- Cervical radiculopathy or referred neck-related shoulder pain
- Inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)
- Neurological disorders affecting upper extremity function
- Corticosteroid injection in the shoulder within the last 6 months
- Ongoing physiotherapy or manual therapy treatment for shoulder pain in the last 3 months
- Severe systemic or psychiatric conditions that may interfere with participation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Exercise Only Group
Participants will receive a standardized shoulder exercise program focusing on rotator cuff strengthening, scapular stabilization, stretching, and range of motion exercises.
|
A standardized physiotherapy program including rotator cuff strengthening exercises, scapular stabilization exercises, posterior capsule stretching, pectoralis minor stretching, and active range of motion exercises for the shoulder.3
sessions per week for 8 weeks (supervised and/or home-based depending on protocol design)
|
|
Experimentální: Exercise + Mobilization With Movement (MWM) Group
Participants will receive the same standardized exercise program in addition to glenohumeral joint Mobilization With Movement (MWM) techniques.
|
A standardized physiotherapy program including rotator cuff strengthening exercises, scapular stabilization exercises, posterior capsule stretching, pectoralis minor stretching, and active range of motion exercises for the shoulder.3
sessions per week for 8 weeks (supervised and/or home-based depending on protocol design)
Glenohumeral joint Mobilization With Movement techniques (Mulligan concept), including posterior glide and inferior glide techniques applied during active shoulder movement, aimed at improving pain-free range of motion and function. Application Details: Grade: Sustained glide during active movement Techniques: Posterior glide, inferior glide Dosage: 2 sessions per week for 8 weeks Performed by licensed physiotherapist |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Supraspinatus Tendon Thickness
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
Supraspinatus tendon thickness will be measured using musculoskeletal ultrasound imaging.
Measurements will be obtained at the tendon footprint in the longitudinal plane using a high-frequency linear transducer.
Tendon thickness will be recorded in millimeters (mm).
This variable is selected as the primary structural outcome to evaluate morphological changes associated with the intervention.
Increased or decreased tendon thickness will be interpreted in relation to clinical improvement and tissue remodeling.
|
Baseline (Week 0) and post-intervention (Week 8)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
Participants will rate their pain at rest, during activity, and at night.
Scores range from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Shoulder Pain and Disability Index (SPADI)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
SPADI will be used to evaluate shoulder pain and functional disability.
The questionnaire consists of pain and disability subscales, with total scores ranging from 0 to 100.
Higher scores indicate greater disability.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
QuickDASH Score
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
QuickDASH will assess upper limb disability and symptoms.
It consists of 11 items scored from 1 to 5, converted to a scale from 0 to 100.
Higher scores indicate greater functional limitation.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Shoulder Range of Motion (ROM)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
Active shoulder flexion, abduction, internal rotation, and external rotation will be measured using a goniometer or digital inclinometer in degrees.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Shoulder Muscle Strength
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
Isometric muscle strength of shoulder abductors and external rotators will be measured using a handheld dynamometer.
Results will be recorded in Newtons (N).
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Joint Position Sense (JPS)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
Shoulder proprioception will be assessed using a laser pointer method.
The participant will attempt to reproduce a target shoulder flexion position with eyes closed.
Deviation from the target position will be recorded in centimeters.
Higher values indicate poorer proprioception.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Tampa Scale of Kinesiophobia (TSK)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
TSK will be used to assess fear of movement and reinjury.
The scale consists of 17 items scored on a 4-point Likert scale.
Total scores range from 17 to 68, with higher scores indicating greater fear of movement.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Pain Catastrophizing Scale (PCS)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
PCS measures exaggerated negative cognitive responses to pain, including rumination, magnification, and helplessness.
It consists of 13 items with a total score ranging from 0 to 52.
Higher scores indicate greater catastrophizing.
|
Baseline (Week 0) and post-intervention (Week 8)
|
|
Central Sensitization Inventory (CSI)
Časové okno: Baseline (Week 0) and post-intervention (Week 8)
|
CSI is a 25-item questionnaire assessing symptoms related to central sensitization.
Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom severity.
|
Baseline (Week 0) and post-intervention (Week 8)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Ömer ÖZÇELEP, Assist. Prof., Kirsehir Ahi Evran Universitesi
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KAEÜFTR
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Syndrom rotátorové manžety
-
Salisbury UniversityZatím nenabíráme
-
GlaxoSmithKlineZatím nenabíráme
-
Lokman Hekim UniversityDokončenoSubakromiální impingement syndrom | Syndrom nárazového ramene | Syndrom nárazu rotátorové manžetyTurecko (Türkiye)
-
Charite University, Berlin, GermanyNáborSyndrom postintenzivní péčeNěmecko
-
Unravel Biosciences, Inc.NáborPitt Hopkinsův syndromKolumbie
-
Cairo UniversityDokončeno
-
Cairo UniversityDokončeno
-
Ministry of Public Health, Democratic Republic...National Institutes of Health (NIH); Oregon Health and Science University; National... a další spolupracovníciDokončenoSyndrom neurotoxicity, Cassava | Syndrom neurotoxicity, kyanát | Syndrom neurotoxicity, kyanid | Syndrom neurotoxicity, thiokyanátKongo, Demokratická republika
-
Cliniques universitaires Saint-Luc- Université...UkončenoSyndrom multiorgánové dysfunkce | SEPTICKÝ ŠOK | SYNDROM SEPSEBelgie
-
Neuren Pharmaceuticals LimitedNáborPhelan-McDermidův syndromSpojené státy