- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673745
Effect of Instrument Assisted Soft Tissue Mobilization and Dynamic Cupping
January 1, 2025 updated by: Riphah International University
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Riphah International University Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Instrumental assisted soft tissue mobilization
Instrument assisted soft tissue mobilization (IASTM) and dynamic cupping are manual therapy techniques used to address soft tissue restrictions and improve joint mobility and function.
In the context of children with post-fracture elbow stiffness, these techniques can have several physiological effects.
(14) This process involves the use of specialized tools to apply pressure and friction to the affected soft tissues.
Which can help break down scar tissue and adhesions that may have formed following the fracture, allowing for improved tissue flexibility and mobility.
This can stimulate blood flow to the area, promoting tissue healing and reducing inflammation
|
Group A received IASTM treatment, which will be given by the "Edge tool", that is an ergonomically designed stainless steel instrument and offers several different hand holds, eliminating operator fatigue.
Prior to the treatment, the IASTM therapeutic effects will be explained.
The scanning assessment will be done to identify areas of restrictions directed by the gritty sensations using the Edge tool.
Each restriction will be treated with the tool for 30-60 sec and given.
This treatment will be given for 30 minutes for 3 days per week for 4 weeks
|
|
Experimental: Dynamic cupping therapy
Dynamic cupping, on the other hand, utilizes suction cups placed on the skin to create negative pressure.
This can help stretch and release tight muscles and fascia, increasing tissue flexibility and reducing stiffness.
The rhythmic movement of the cups which can also stimulate lymphatic drainage and promote circulation, this will increase the removal of metabolic waste products and will also reduce swelling.
(16) Both the techniques can help address the underlying soft tissue restrictions and joint stiffness commonly seen following a fracture.
By improving tissue flexibility reducing inflammation, and enhancing circulation IASTM and dynamic cupping can contribute to restoring normal elbow range of motion and function in children with post fracture elbow stiffness.
Instrument assisted soft tissue mobilization is one of the recently used popular myofascial intervention.
It is known to improve the range of motion, function and improvestrigger point of the muscles.
In recent studies it i
|
On the contrary, group B the patient will be seated in a chair with the elbow flexed on the plinth to relax the forearm muscles.
The area around the elbow joint will be cleaned with alcohol to remove any foreign bodies from the treated area.
Dynamic cupping therapy for elbow stiffness will begin with an assessment of the patient's condition, where factors such as the extent of stiffness and range of motion in the elbow joint will be evaluated.
Following this assessment, lubricant will be applied to the skin surrounding the elbow to facilitate smooth movement of the cups.
Cups of suitable size and material will then be strategically placed around the elbow joint, and suction will be created inside each cup to create a vacuum effect.
Once thesecurely attached, the practitioner will move them around the elbow area using gentle techniques such as gliding or pumping motions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time Frame: 6 weeks
|
Function was assessed by the Disability of arm shoulder and hand questionnaire (DASH) (Reliability- ICC- 0.96; validity- 0.70), which is a 30-item patient-reported questionnaire, which can rate difficulty and interference with function on a 5-point Likert scale used to evaluate impairments, activity limitations, as well as participation restrictions in both leisure activities and work due to elbow dysfunction, regardless of which arm is affected.
The scores for all items are then summed up to a scale score, where higher scores indicate higher disability
|
6 weeks
|
|
Goniometer Measurement for Range of motion
Time Frame: 6 weeks
|
Universal goniometer is a device which is used to measure the range of motion of the joint.
It has both art and science of measuring joint plane by 2 form.
It has short and long arm.
It has 3 parts Center part is known as fulcrum or axis with two arms.
One is moving arm and the other is stationary or fixed arm.
ROM of the elbow joint and forearm was measured using the universal half goniometer (Reliability-ICC-0.53-0.97.)
Positions used to measure elbow flexion-extension were in supine position, whereas the forearm pronation-supination was done in sitting position .
|
6 weeks
|
|
Numeric Pain rating Scale
Time Frame: 6 weeks
|
Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain.
Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable.
It has good reliability of 0.79 and validity of 0.96.
(26)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sana Aziz, MS, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2024
Primary Completion (Actual)
December 25, 2024
Study Completion (Actual)
December 26, 2024
Study Registration Dates
First Submitted
November 3, 2024
First Submitted That Met QC Criteria
November 3, 2024
First Posted (Actual)
November 5, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 1, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Instrument assisted soft tissue mobilization (IASTM) and dynamic cupping are manual therapy techniques used to address soft tissue restrictions and improve joint mobility and function.
In the context of children with post-fracture elbow stiffness, these techniques can have several physiological effects.
(14) This process involves the use of specialized tools to apply pressure and friction to the affected soft tissues.
Which can help break down scar tissue and adhesions that may have formed following the fracture, allowing for improved tissue flexibility and mobility.
This can stimulate blood flow to the area, promoting tissue healing and reducing inflammation.
(15) Dynamic cupping, on the other hand, utilizes suction cups placed on the skin to create negative pressure.
This can help stretch and release tight muscles and fascia, increasing tissue flexibility and reducing stiffness.
The rhythmic movement of the cups which can also stimulate lymphatic drainage and promote circulation, thi
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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