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Mobilization With Movement in Rotator Cuff Tendinopathy

15 giugno 2026 aggiornato da: Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Exercise Only Group
Participants will receive a standardized shoulder exercise program focusing on rotator cuff strengthening, scapular stabilization, stretching, and range of motion exercises.
Comportamentale: Exercise Therapy
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)
Sperimentale: Exercise + Mobilization With Movement (MWM) Group
Participants will receive the same standardized exercise program in addition to glenohumeral joint Mobilization With Movement (MWM) techniques.
Comportamentale: Exercise Therapy
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)
Procedura: Mobilization With Movement (MWM)

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Supraspinatus Tendon Thickness
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Intensity
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kirsehir Ahi Evran Universitesi

Investigatori

  • Direttore dello studio: Ömer ÖZÇELEP, Assist. Prof., Kirsehir Ahi Evran Universitesi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 luglio 2026

Completamento primario (Stimato)

12 dicembre 2026

Completamento dello studio (Stimato)

13 dicembre 2026

Date di iscrizione allo studio

Primo inviato

15 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KAEÜFTR

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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