Fractures, BoneNCT06673745
Effect of Instrument Assisted Soft Tissue Mobilization and Dynamic Cupping
A study testing IASTM and Dynamic cupping therapy in people with Fractures, Bone, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- IASTM and Dynamic cupping therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Sep 2024to 26 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University Lahore
Lahore, Punjab Province, 54700
About this study
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
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
Read the 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
- Conditions
- Fractures, Bone
- Being tested
- IASTM, Dynamic cupping therapy
- Keywords
- elbow, post fracture stiffness
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Instrumental assisted soft tissue mobilization | Experimental | 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 Receives: Other: IASTM |
| Dynamic cupping therapy | Experimental | 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 Receives: Other: Dynamic cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand Questionnaire
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
Measured: 6 weeks
Goniometer Measurement for Range of motion
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 .
Measured: 6 weeks
Numeric Pain rating Scale
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start24 Sep 2024
- Primary completion25 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Aziz, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673745
- Sponsor's protocol ID
- REC/RCR&AHS/24/0720
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 34818976
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06673745
- Acronym / sponsor ID
- REC/RCR&AHS/24/0720
- Conditions
- Fractures, Bone
- Keywords
- elbow, post fracture stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Instrumental assisted soft tissue mobilization | Experimental | Other: IASTMInstrument 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 |
| Dynamic cupping therapy | Experimental | Other: Dynamic cupping therapyDynamic 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 |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASTMGroup 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 | Other | Instrumental assisted soft tissue mobilization |
| Dynamic cupping therapyOn 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. | Other | Dynamic cupping therapy |
Primary outcome
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
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 .
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 34818976Aksan 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.
- Individual participant dataSharing planned: No. 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
Related trials for Fractures, Bone
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sana Aziz, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM and Dynamic cupping therapy in people with Fractures, Bone, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand Questionnaire (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06673745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.