Effect of Instrument Assisted Soft Tissue Mobilization and Dynamic Cupping

NCT ID: NCT06673745

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2024-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fractures, Bone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
This will be a randomized upping c clinical trial on 28 participant on 6 to 15 years group A will get instrument assisted soft tissue mobilisation and group B will get dynamic

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 Type EXPERIMENTAL

IASTM

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Dynamic cupping therapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IASTM

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

Intervention Type OTHER

Dynamic cupping therapy

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sana Aziz, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah International University Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34818976 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR&AHS/24/0720

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.