Clinical trial NCT06673745: Effect of Instrument Assisted Soft Tissue Mobilization and Dynamic Cupping
Official title: Comparative Effects of Instrument Assisted Soft Tissue Mobilisation and Dynamic Cupping on Elbow Range of Motion and Function in Children With Post Fracture Elbow Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Keywords: elbow
post fracture stiffness
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized clinical trail conducted on 28 participants of age 6 to 15 years .group A will get instrument assisted soft issue mobilisation and group B will get dynamic cupping therapy
Primary purpose: OTHER

Brief summary: Children who experience fractures may develop stiffness and limited range of motion in their affected joints, notably the elbow. Although conventional rehabilitation approaches have demonstrated some effectiveness, innovative methods like Instrument Assisted Soft Tissue Mobilization (IASTM) and Dynamic Cupping hold promise for enhancing outcomes. These techniques represent emerging therapies aimed at improving range of motion and function across different musculoskeletal conditions. However, there is a lack of comparative research examining their efficacy specifically in pediatric patients with post-fracture elbow stiffness

Detailed description: This will be a randomized clinical trial conducted on 28 participants. Data will be collected from Khatoon e Jannat hospital, Mujahid hospital and children hospital of Faisalabad. The study includes children aged 6 to 15, both genders, experiencing elbow postoperative stiffness and with a loss of extension of at least -30 degrees and/or flexion of no more than 120 degrees. Participants excluded from the study are those who declined consent, had pathological fractures, and associated ipsilateral injuries, bilateral upper extremity injuries, neuro-vascular disorders, heterotrophic ossification, or contraindications for IASTM. A sample of 28 will be divided in to two groups. Each group will consist of 14 participants. Group A will receive instrument assisted soft tissue mobilization. On the contrary group B will receive dynamic cupping therapy. Both groups will be given conventional therapy along with prescribed intervention. Intervention will be given for 30 minutes for 3 sessions per week for 4 weeks. Data will be collected before and after the intervention to assess range of motion and function with a help of goniometer and Disability arm shoulder and hand questionnaire. Data will be analyzed by using SPSS version 26.0

Eligibility criteria: Inclusion criteria

* Age from 6 to 15 years (23)
* Both genders Participant with elbow postoperative stiffness with loss of extension of ≥-30 degrees and/or flexion ≤120 degrees Participant with at least 6-week post-surgery with open reduction and internal fixation done for either of the following fractures.

Exclusion Criteria:

* Participants who declined consent.
* Participants who had pathological fractures, associated ipsilateral injuries, bilateral upper extremity injuries, neuro-vascular disorders, heterotrophic ossification, and contraindications for IASTM

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: 6 weeks
measure: Goniometer Measurement for Range of motion
timeFrame: 6 weeks
measure: Numeric Pain rating Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sana Aziz, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aksan Sadikoglu B, Analay Akbaba Y, Taskiran H. Effects of ischemic compression and instrument-assisted soft tissue mobilization techniques in trigger point therapy in patients with rotator cuff pathology: randomized controlled study. Somatosens Mot Res. 2022 Mar;39(1):70-80. doi: 10.1080/08990220.2021.2005015. Epub 2021 Nov 24.