- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07598526
Comparative Effects of Mulligan Mobilization With and Without Myofascial Release Technique in Management of Post Traumatic Elbow Stiffness
13 maggio 2026 aggiornato da: Maryam Safdar, University of Faisalabad
The Randomize Clinical Trial will involve 30 participants with post traumatic elbow stiffness recruited from Madinah Teaching Hospital and Chiniot General hospital Faisalabad.
Consecutive sampling technique will be used.
Study will include individuals with >30° extension loss and <120° flexion, 50° in both directions for pronation-supination, who are 3-6 weeks post-POP removal from radiograph confirmation of skeletal/bone healing will be insured, who have elbow pain from 3 to 5/10 on NPRS and have fully healed fractures.
Both intra-articular and extra-articular injuries will be accepted.
DASH Score with 45 to 50 points.
Study will exclude pathological or acute fractures, burns, brain trauma, neurological or psychological disorders, history of pre-operative osteoarthritis.
Consent will be taken written and verbal from participants before including into study.
Patients will be allocated with online randomization generator method into 2 groups.
Group A will receive Mulligan Mobilization with Myofascial release technique, while Group B will receive Mulligan Mobilization alone.
Hot pack for 20 minutes before treatment and static stretching after treatment will apply in both groups.
Each stretch is performed 10 repetition with hold duration of 30 sec and rest period 15 sec between each stretch.
Total 3 sessions per week for 4 weeks (12 sessions) on alternative days will be given.
Outcome of study will be elbow pain, elbow range of motion (flexion and extension) and functional disability will be measure by using Numerical Pain Rating Scale, Universal Goniometer and Dash Questionnaire Score respectively.
Data will be investigated by using SPSS version 2023.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
Elbow stiffness is a disabling condition that interferes in daily living activities after trauma.
The study's goal is to compare the results of Mulligan Mobilization with and without Myofascial Release Technique in management of post traumatic elbow stiffness.
The Randomize Clinical Trial will involve 30 participants with post traumatic elbow stiffness recruited from Madinah Teaching Hospital and Chiniot General hospital Faisalabad.
Consecutive sampling technique will be used.
Study will include individuals with >30° extension loss and <120° flexion, 50° in both directions for pronation-supination, who are 3-6 weeks post-POP removal from radiograph confirmation of skeletal/bone healing will be insured, who have elbow pain from 3 to 5/10 on NPRS and have fully healed fractures.
Both intra-articular and extra-articular injuries will be accepted.
DASH Score with 45 to 50 points.
Study will exclude pathological or acute fractures, burns, brain trauma, neurological or psychological disorders, history of pre-operative osteoarthritis.
Consent will be taken written and verbal from participants before including into study.
Patients will be allocated with online randomization generator method into 2 groups.
Group A will receive Mulligan Mobilization with Myofascial release technique, while Group B will receive Mulligan Mobilization alone.
Hot pack for 20 minutes before treatment and static stretching after treatment will apply in both groups.
Each stretch is performed 10 repetition with hold duration of 30 sec and rest period 15 sec between each stretch.
Total 3 sessions per week for 4 weeks (12 sessions) on alternative days will be given.
Outcome of study will be elbow pain, elbow range of motion (flexion and extension) and functional disability will be measure by using Numerical Pain Rating Scale, Universal Goniometer and Dash Questionnaire Score respectively.
Data will be investigated by using SPSS version 2023.
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Maryam Safdar Dr, MS Physical Therapy (MSK)
- Numero di telefono: +92-3217978088
- Email: maryamsafdar.DPT@tuf.edu.pk
Backup dei contatti dello studio
- Nome: Dr Muhammad Ateeb, PhD Public Health
- Numero di telefono: +92-3357333383
- Email: mateeb.oric@tuf.edu.pk
Luoghi di studio
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 38000
- Outdoor Patient Department (OPD) of Madinah Teaching Hospital and Chiniot General Hospital, Faisalabad.
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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
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Participants aged between 17 and 44 years will be included in the study (Sun et al., 2025).
- Both male and female patients experiencing mild to moderate elbow pain (3/10 to 5/10 on NPRS) along with restricted range of motion will be eligible (Zulfqar et al., 2021).
- Subjects having elbow movement limitation of more than 30° in extension, flexion less than 120°, and 50° restriction in both pronation and supination will be included (Masci et al., 2020).
- Participants will be recruited 3 to 6 weeks after POP removal, and radiographic confirmation of bone/skeletal healing will be ensured before inclusion (Morrey et al., 2017).
- Patients with both intra-articular and extra-articular fractures will be considered eligible.
- Individuals with DASH scores ranging from 45 to 50 points will be included.
- Only patients willing to participate in the study will be enrolled.
Exclusion Criteria:
- Patients with a history of previous surgical excision will be excluded from the study (Zheng et al., 2018).
- Participants presenting with pathological fractures will not be included (Zulfqar et al., 2021).
- Patients in the acute stage of fracture will be excluded from participation (Zulfqar et al., 2021).
- Individuals with metabolic or malignant conditions causing elbow stiffness, such as gout or osteosarcoma, will not be eligible (Fusaro et al., 2014).
- Patients with elbow fractures associated with a history of metal implants will be excluded (Zheng et al., 2018).
- Individuals who have already received physiotherapy treatment or medication for the condition will not be included.
- Patients diagnosed with psychological illnesses that may interfere with following instructions will be excluded.
- Participants with brain trauma or referred neurological symptoms, including numbness, dizziness, or hyperesthesia, will not be considered (Fusaro et al., 2014).
- Patients with structural or postural abnormalities involving the shoulder or wrist will be excluded.
- Individuals with open skin wounds or burn injuries around the affected area will not be included.
- Patients with a pre-operative history of arthritis will also be excluded from the study.
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 |
|---|---|
|
Sperimentale: Group A (Mulligan Mobilization with Myofascial Release Technique)
Participants in Group A will receive a structured treatment program including Mulligan mobilization along with myofascial release techniques aimed at reducing pain, improving functional disability, and enhancing elbow range of motion.
Each session will last 40-45 minutes and will be administered three times per week for four weeks.
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The patient will be positioned supine at the edge of the table with the shoulder abducted to 90°, elbow flexed, and forearm supinated.
The therapist will stabilize the distal humerus and use a belt around the pelvis while applying a sustained glide through the forearm.
Active elbow flexion/extension will be performed with gentle, pain-free overpressure at end range.
The technique will be repeated 6-10 times for 1-3 sets with 15-second rest intervals.
Myofascial release will be applied with the patient supine, elbow slightly flexed and forearm pronated.
The therapist will treat from lateral epicondyle to wrist extensors while the patient performs small elbow movements.
Both groups will receive a hot pack application for 20 minutes as a baseline treatment prior to the intervention, followed by static stretching after the session.
Each stretch will be performed for 10 repetitions, with a 30-second hold and a 15-second rest interval between stretches.
|
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Comparatore attivo: Group B (Mulligan Mobilization alone)
Participants in Group B will be treated with Mulligan Mobilization alone to help reduce pain and improve elbow range of motion.
The intervention will be delivered in 40-45 minute sessions, three times per week, for four consecutive weeks.
|
The patient will be positioned supine at the edge of the table with the shoulder abducted to 90°, elbow flexed, and forearm supinated.
The therapist will stabilize the distal humerus and use a belt around the pelvis while applying a sustained glide through the forearm.
Active elbow flexion/extension will be performed with gentle, pain-free overpressure at end range.
The technique will be repeated 6-10 times for 1-3 sets with 15-second rest intervals.
Both groups will receive a hot pack application for 20 minutes as a baseline treatment prior to the intervention, followed by static stretching after the session.
Each stretch will be performed for 10 repetitions, with a 30-second hold and a 15-second rest interval between stretches.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Elbow pain
Lasso di tempo: Baseline and week 4
|
The Numeric Pain Rating Scale (NPRS) is an 11-point scale used to assess pain intensity.
The scale ranges from 0, indicating no pain, to 10, representing the worst imaginable pain.
It is considered a reliable and valid tool for evaluating changes in pain severity over time
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Baseline and week 4
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Elbow range of motion
Lasso di tempo: Baseline and week 4
|
The universal goniometer is a reliable and effective instrument commonly used to assess elbow joint range of motion
|
Baseline and week 4
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Functional disability
Lasso di tempo: Baseline and Week 4
|
The DASH questionnaire is designed to evaluate upper limb function and related symptoms.
It assesses the level of difficulty an individual experiences while performing daily activities involving the arm, shoulder, and hand due to pain, weakness, or movement limitations.
The questionnaire contains 30 items, and scores range from 0 (no disability) to 100 (maximum disability), with higher scores indicating greater functional impairment
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Baseline and Week 4
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Dr Maryam Safdar, The University of Faisalabad
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Pourahmadi MR, Mohsenifar H, Dariush M, Aftabi A, Amiri A. Effectiveness of mobilization with movement (Mulligan concept techniques) on low back pain: a systematic review. Clin Rehabil. 2018 Oct;32(10):1289-1298. doi: 10.1177/0269215518778321. Epub 2018 May 30.
- Kain J, Martorello L, Swanson E, Sego S. Comparison of an indirect tri-planar myofascial release (MFR) technique and a hot pack for increasing range of motion. J Bodyw Mov Ther. 2011 Jan;15(1):63-7. doi: 10.1016/j.jbmt.2009.12.002. Epub 2010 Jan 27.
- Masci G, Cazzato G, Milano G, Ciolli G, Malerba G, Perisano C, Greco T, Osvaldo P, Maccauro G, Liuzza F. The stiff elbow: Current concepts. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8661. doi: 10.4081/or.2020.8661. eCollection 2020 Jun 29.
- Zhang D, Nazarian A, Rodriguez EK. Post-traumatic elbow stiffness: Pathogenesis and current treatments. Shoulder Elbow. 2020 Feb;12(1):38-45. doi: 10.1177/1758573218793903. Epub 2018 Aug 8.
- Sevik Kacmaz K, Unver B. Immediate Effects of Mulligan Mobilization on Elbow Proprioception in Healthy Individuals: A Randomized Placebo-Controlled Single-Blind Study. J Manipulative Physiol Ther. 2023 Jan;46(1):59-64. doi: 10.1016/j.jmpt.2023.05.001. Epub 2023 Jul 7.
- Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.
- van Rijn SF, Zwerus EL, Koenraadt KL, Jacobs WC, van den Bekerom MP, Eygendaal D. The reliability and validity of goniometric elbow measurements in adults: A systematic review of the literature. Shoulder Elbow. 2018 Oct;10(4):274-284. doi: 10.1177/1758573218774326. Epub 2018 Jun 3.
- Zheng W, Liu J, Song J, Fan C. Risk factors for development of severe post-traumatic elbow stiffness. Int Orthop. 2018 Mar;42(3):595-600. doi: 10.1007/s00264-017-3657-1. Epub 2017 Oct 7.
- Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the numeric pain rating scale, patient-rated tennis elbow evaluation, and tennis elbow function scale in patients with lateral elbow tendinopathy. Physiother Theory Pract. 2025 Aug;41(8):1712-1720. doi: 10.1080/09593985.2025.2450090. Epub 2025 Jan 10.
- Sun Z, Li J, van Riet R, Ho PC, Hildebrand KA, Puah KL, Shih JT, Li Z, Chanlalit C, Kekatpure AL, Zhang K, Liu S, Gong M, Huang F, Yan H, Mi J, Lu J, Zha Y, Xiang Z, Xiang M, Li F, Jiang S, Liu W, Zhong B, Ding J, Ruan H, Ouyang Y, Wang W, Yu S, Chen S, Qian Y, Xu Y, Hu Y, Xu J, Jiang X, Jeon IH, Fan C. Clinical guideline on the open arthrolysis for post-traumatic elbow stiffness in adult patients. J Shoulder Elbow Surg. 2026 Mar;35(3):811-825. doi: 10.1016/j.jse.2025.07.015. Epub 2025 Aug 25.
- Ling SK, Lui TH, Faan YS, Lui PW, Ngai WK. Post-traumatic elbow rotational stiffness. Shoulder Elbow. 2014 Apr;6(2):119-23. doi: 10.1177/1758573214524935. Epub 2014 Mar 3.
- He X, Fen Q, Yang J, Lei Y, Heng L, Zhang K. Risk Factors of Elbow Stiffness After Open Reduction and Internal Fixation of the Terrible Triad of the Elbow Joint. Orthop Surg. 2021 Apr;13(2):530-536. doi: 10.1111/os.12879. Epub 2021 Feb 22.
- Fusaro I, Orsini S, Stignani Kantar S, Sforza T, Benedetti MG, Bettelli G, Rotini R. Elbow rehabilitation in traumatic pathology. Musculoskelet Surg. 2014 Apr;98 Suppl 1:95-102. doi: 10.1007/s12306-014-0328-x. Epub 2014 Mar 25.
- Fan M, Xu F, Fei C, Liu Y, Yang Z, Song Z. Post-traumatic elbow stiffness: etiology, risk factors and current treatments. Front Surg. 2025 Aug 26;12:1643326. doi: 10.3389/fsurg.2025.1643326. eCollection 2025.
- Akhtar A, Hughes B, Watts AC. The post-traumatic stiff elbow: A review. J Clin Orthop Trauma. 2021 May 19;19:125-131. doi: 10.1016/j.jcot.2021.05.006. eCollection 2021 Aug.
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)
20 maggio 2026
Completamento primario (Stimato)
20 settembre 2026
Completamento dello studio (Stimato)
20 settembre 2026
Date di iscrizione allo studio
Primo inviato
13 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 maggio 2026
Primo Inserito (Effettivo)
20 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TUF/EIRB/179/26
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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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