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NCT Number: NCT06673745

Effect of Instrument Assisted Soft Tissue Mobilization and Dynamic Cupping

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

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Key information

Conditions

Fractures, Bone Wounds and Injuries

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University Lahore

Lahore, Punjab Province, 54700, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IASTM

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

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.

Primary outcomes

  1. 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

  2. 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 .

  3. 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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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