NCT07598526

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Sep 2026

First Submitted

Initial submission to the registry

May 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Post op elbow stiffnessMulligan MobilizationMyofascial Release TechniqueDisabilities of Arm, Shoulder, and HandElbow pain

Outcome Measures

Primary Outcomes (2)

  • Elbow pain

    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

    Baseline and week 4

  • Elbow range of motion

    The universal goniometer is a reliable and effective instrument commonly used to assess elbow joint range of motion

    Baseline and week 4

Secondary Outcomes (1)

  • Functional disability

    Baseline and Week 4

Study Arms (2)

Group A (Mulligan Mobilization with Myofascial Release Technique)

EXPERIMENTAL

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.

Other: Group A (Mulligan Mobilization with Myofascial Release Technique)

Group B (Mulligan Mobilization alone)

ACTIVE COMPARATOR

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.

Other: Group B (Mulligan Mobilization alone)

Interventions

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.

Group A (Mulligan Mobilization with Myofascial Release Technique)

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.

Group B (Mulligan Mobilization alone)

Eligibility Criteria

Age17 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outdoor Patient Department (OPD) of Madinah Teaching Hospital and Chiniot General Hospital, Faisalabad.

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (15)

  • 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.

    PMID: 28988397BACKGROUND
  • 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.

    PMID: 32010232BACKGROUND
  • 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.

    PMID: 39793982BACKGROUND
  • 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.

    PMID: 30214494BACKGROUND
  • 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.

    PMID: 40865905BACKGROUND
  • 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.

    PMID: 29843520BACKGROUND
  • 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.

    PMID: 32913596BACKGROUND
  • 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.

    PMID: 27582925BACKGROUND
  • 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.

    PMID: 21147420BACKGROUND
  • 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.

    PMID: 37422752BACKGROUND
  • 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.

    PMID: 33619861BACKGROUND
  • 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.

    PMID: 24659223BACKGROUND
  • 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.

    PMID: 40932855BACKGROUND
  • 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.

    PMID: 30304958BACKGROUND
  • 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.

    PMID: 34277339BACKGROUND

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Dr Maryam Safdar

    The University of Faisalabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Safdar Dr, MS Physical Therapy (MSK)

CONTACT

Dr Muhammad Ateeb, PhD Public Health

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single-blind study in which participants are unaware of their group allocation. The Group A and B receive identical-appearing interventions. Allocation is concealed from participants but known to the investigators and data analysts.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This parallel-group randomized clinical trial will include 30 participants, with sample size calculated using OpenEpi. Patients with post-traumatic elbow stiffness will be recruited from public hospitals of Faisalabad through consecutive sampling. After consent, participants will be randomized using an online generator. Group A will receive Mulligan Mobilization with Myofascial Release, while Group B will receive Mulligan Mobilization alone. Both groups will receive hot packs and static stretching, 3 sessions/week for 4 weeks. Outcomes will include pain, ROM, and disability measured through NPRS, Goniometer, and DASH questionnaire. Data will be analyzed using SPSS 2023.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 20, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations