The Combined Effect of Mulligan Mobilization, Pain Neuroscience-Based Training, and Core Stabilization Exercises in Frozen Shoulder Patients
The purpose of this randomized controlled study is to investigate the effects of a combined rehabilitation program consisting of Mulligan Mobilization with Movement (MWM), Pain Neuroscience Education (PNE), and core stabilization exercises in individuals with adhesive capsulitis (frozen shoulder).
The main questions this study aims to answer are:
Does the combination of Mulligan mobilization, Pain Neuroscience Education, and core stabilization exercises reduce pain in individuals with adhesive capsulitis? Does this combined intervention improve shoulder range of motion, shoulder function, quality of life, scapular dyskinesis, and pain catastrophizing compared with conventional physical therapy?
Participants diagnosed with adhesive capsulitis will be randomly assigned to one of two groups. The intervention group will receive Mulligan mobilization, Pain Neuroscience Education, and core stabilization exercises, while the control group will receive conventional physical therapy, including TENS, hot-pack application, passive joint mobilization, and stretching exercises. Both groups will participate in treatment sessions three times per week for six weeks. Outcome measures will be assessed at baseline and after completion of the 6-week intervention period.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Adhesive capsulitis, commonly known as frozen shoulder, is a musculoskeletal disorder characterized by shoulder pain, progressive restriction of active and passive range of motion, and functional disability. The condition negatively affects activities of daily living and quality of life and is most frequently observed in individuals between 40 and 65 years of age. Despite the widespread use of conventional physiotherapy interventions, optimal treatment strategies remain under investigation.
Mulligan Mobilization with Movement (MWM) is a manual therapy technique that combines sustained accessory joint glides with active pain-free movement. Previous studies have demonstrated beneficial effects of Mulligan mobilization on pain reduction and functional improvement in individuals with adhesive capsulitis. Pain Neuroscience Education (PNE) is an educational approach designed to improve patients' understanding of pain mechanisms and reduce maladaptive beliefs related to pain. Core stabilization exercises, particularly those based on Dynamic Neuromuscular Stabilization (DNS) principles, aim to improve postural control, neuromuscular coordination, and movement efficiency.
Although the effectiveness of Mulligan mobilization has been investigated in patients with adhesive capsulitis, there is limited evidence regarding the use of Pain Neuroscience Education in this population, and the effects of DNS-based core stabilization exercises have not been adequately studied. Furthermore, no previous study has examined the combined effects of Mulligan mobilization, Pain Neuroscience Education, and core stabilization exercises in individuals with adhesive capsulitis.
This randomized controlled trial aims to evaluate the short-term effects of a combined intervention consisting of Mulligan mobilization, Pain Neuroscience Education, and core stabilization exercises on pain intensity, shoulder range of motion, shoulder function, pain catastrophizing, scapular dyskinesis, core stability, and health-related quality of life in individuals with adhesive capsulitis.
Participants diagnosed with adhesive capsulitis will be randomly allocated to one of two groups. The experimental group will receive Mulligan mobilization, Pain Neuroscience Education, and DNS-based core stabilization exercises. The control group will receive conventional physical therapy consisting of transcutaneous electrical nerve stimulation (TENS), hot-pack application, passive joint mobilization, and stretching exercises. Both groups will participate in treatment sessions three times per week for six weeks. Assessments will be conducted at baseline and after completion of the intervention period.
The findings of this study may contribute to the development of a more comprehensive rehabilitation approach for individuals with adhesive capsulitis and provide evidence regarding the effectiveness of combining manual therapy, pain education, and core stabilization strategies in clinical practice.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dilay Döner
- Telefonnummer: +90 0535 019 58 83
- E-mail: dilay.doner@std.yeditepe.edu.tr
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Rekruttering
- Life Med Tıp Merkezi
-
Kontakt:
- Murat Gökhan Döner
- Telefonnummer: +90 532 342 98 15
- E-mail: fztgokhandoner@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 65 years
- Diagnosis of adhesive capsulitis confirmed by an orthopedic surgeon or a physical medicine and rehabilitation physician
- Presence of shoulder pain and limitation of shoulder range of motion
- Ability to communicate verbally
- Ability to understand study procedures and educational content
- Willingness to participate and provide written informed consent
- Mini-Mental State Examination (MMSE) score of 24 or higher
- Ability to attend treatment and assessment sessions regularly
Exclusion Criteria:
- MMSE score below 24
- Severe cognitive impairment
- Severe psychiatric disorders
- Active infectious disease
- Active malignancy
- Uncontrolled cardiovascular disease
- Presence of a cardiac pacemaker
- Contraindications to transcutaneous electrical nerve stimulation (TENS)
- Neurological disorders that may affect participation or outcomes
- Systemic diseases that may interfere with the safe implementation of the intervention
- Inability to comply with the study protocol or attend scheduled sessions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Experimental - Combined Treatment Group
Mulligan Mobilization + Pain Neuroscience Education + Core Stabilization Exercises
|
Participants will receive Pain Neuroscience Education focused on the biopsychosocial nature of pain, central sensitization, the distinction between pain and tissue damage, and strategies to reduce fear of movement.
The initial educational session will last approximately 15-20 minutes, followed by 5-10 minute reinforcement sessions throughout the intervention period.
Education will be delivered through verbal explanations and interactive discussion.
Participants will receive Mulligan Mobilization with Movement techniques applied to the glenohumeral joint, including posterolateral glide with active abduction, inferior glide with shoulder flexion, and posterior glide with internal rotation.
Mobilizations will be performed within a pain-free range of motion.
Each technique will be administered in 3 sets of 10 repetitions with 30 seconds of rest between sets.
Treatment will be provided three times per week for six weeks
Participants will perform Dynamic Neuromuscular Stabilization (DNS)-based core stabilization exercises.
The program will include diaphragmatic breathing, supine 90/90 positioning, abdominal bracing, and progression to dead bug, bird-dog, and modified plank exercises as tolerated.
Exercises will be performed in 2-3 sets of 8-12 repetitions with 10-20 second isometric holds.
Progression will occur from stable to unstable surfaces and from static to dynamic activities
|
|
Aktiv komparator: Active Comparator - Conventional Physical Therapy Group
Conventional Physical Therapy (TENS + hot-pack + ROM Exercises + Stretching Exercises)
|
Participants in the control group will receive conventional physical therapy consisting of transcutaneous electrical nerve stimulation (TENS) applied at a sensory level for 20 minutes, hot-pack application for 20 minutes, passive shoulder joint mobilization exercises, pendulum exercises, and wand exercises.
Treatment sessions will be conducted three times per week for six weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: Baseline and week 6
|
Pain intensity during movement will be assessed using the Visual Analog Scale (VAS).
Higher scores indicate greater pain intensity.
|
Baseline and week 6
|
|
Shoulder Function
Tidsramme: Baseline and week 6
|
Shoulder pain, function, and patient satisfaction will be evaluated using the Penn Shoulder Score (PSS).
Higher scores indicate better shoulder function.
|
Baseline and week 6
|
|
Shoulder Range of Motion
Tidsramme: Baseline and week 6
|
Active shoulder flexion, abduction, internal rotation, and external rotation range of motion will be measured using a goniometer.
|
Baseline and week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Catastrophizing
Tidsramme: Baseline and week 6
|
Pain-related catastrophic thinking will be assessed using the Pain Catastrophizing Scale (PCS).
Higher scores indicate greater pain catastrophizing.
|
Baseline and week 6
|
|
Core Stability
Tidsramme: Baseline and week 6
|
Core stability and neuromuscular control will be assessed using the Sahrmann Core Stability Test.
|
Baseline and week 6
|
|
Change in Scapular Dyskinesis
Tidsramme: Baseline and week 6
|
Scapular movement patterns and dyskinesis will be evaluated using the Scapular Dyskinesis Test.
|
Baseline and week 6
|
|
Change in Health-Related Quality of Life
Tidsramme: Baseline and week 6
|
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12).
|
Baseline and week 6
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Leggin BG, Michener LA, Shaffer MA, Brenneman SK, Iannotti JP, Williams GR Jr. The Penn shoulder score: reliability and validity. J Orthop Sports Phys Ther. 2006 Mar;36(3):138-51. doi: 10.2519/jospt.2006.36.3.138.
- Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.
- Razzaq A, Nadeem RD, Akhtar M, Ghazanfar M, Aslam N, Nawaz S. Comparing the effects of muscle energy technique and mulligan mobilization with movements on pain, range of motion, and disability in adhesive capsulitis. J Pak Med Assoc. 2022 Jan;72(1):13-16. doi: 10.47391/JPMA.1360.
- Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment. 1995;7(4):524-532.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dilay Döner
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .