Hand InjuriesIASTMNCT07009197
Effect of Instrument Assisted Soft Tissue Mobilization on Hand Post Surgical Scars in Primary Flexor Tendons Repair in Zone v
A study testing Instrument Assisted Soft Tissue Mobilization and traditional therapy in people with Hand Injuries, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of instrument assisted soft tissue mobilization on hand post surgical scars in primary flexor tendons repair in zone v Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sex will be included in this research
- Hand scar in zone v
- Age varying from 20 to 40
- Hand scar formed post primary flexor tendons repair
Who cannot join
- Vascular injuries requiring arterial repair
- Soft tissue loss
- Fractures
- Tendon in-juries of other zones
- Preexisting problems such as arthritis limiting joint motion
- unhealed wounds or age of scar under 6 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to investigate the effect of instrument assisted soft tissue mobilization on hand post surgical scars in primary flexor tendons repair in zone v
Read the detailed description
The hand plays an important role in independent daily living and in communication with the environment. As the most mobile part of the upper extremity, the hand is actively used in everyday life and professional fields. The flexor tendons of the hand are critical for normal hand function. Injury to these tendons can result in absent finger and wrist flexion, and a subsequent loss of overall hand function. The surgical techniques used to repair these tendons have improved in the past few decades, as have the postoperative rehabilitation protocols. In spite of these advances, flexor tendon repairs continue to be plagued by postoperative scar formation, which limits tendon gliding and prevents a full functional recovery. Many different treatment methods can reduce the trauma and surgical scars. Manual scar treatment is one of these methods. Manual scar therapy to be effective requires applying physiological stimuli adequately to the phase of wound healing. Scar tissue therapy is a treatment for reducing pain and functional limitations, improving pliability, reducing hyper-pigmentation, pruritus, fascial adhesions, to reduce scar thickness and smooth surface area. Instrument assisted soft tissue mobilization (IASTM) is a soft-tissue treatment technique where an instrument is used to provide a mobilizing stimulus to positively affect scar tissue and myofascial adhesion.
- Conditions
- Hand Injuries
- Being tested
- Instrument Assisted Soft Tissue Mobilization, traditional therapy
- Keywords
- Instrument Assisted Soft Tissue Mobilization, Primary Flexor Tendons Repair, Hand Post Surgical Scars
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
the treatment will start by disinfect the instrument between patients to avoid transfer of infections. It is recommended to disinfect the instrument with intermediate-level disinfectants (e.g. isopropyl alcohol), then wash it with soap and water to remove any residuals of the chemical disinfectant off the instrument. If the tools contacts blood, bodily fluids, mucous membranes, or non-intact skin then disinfecting it with high-level disinfectant should be done .IASTM will be done at 30-60 degrees angle for 40-120 seconds+ radiational therapy
traditional therapyOther
the patients will receive traditional therapy in the form of ultrasound, scar massage, and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Twenty-one patients will receive instrument-assisted soft tissue mobilization and traditional therapy three times a week for four weeks. Receives: Other: Instrument Assisted Soft Tissue Mobilization; Other: traditional therapy |
| traditional therapy | Active comparator | Twenty-one patients will receive traditional therapy three times a week for four weeks. Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar assessment
Patient and Observer Scar Assessment Scale (POSAS) will be used to assess scar.It consists of two distinct scales: the OSAS and the PSAS. The PSAS consists of six items: scar-related pain, itchiness, colour, stiffness, thickness and irregularity. Each POSAS item has a 10-point scoring system, with 1 representing normal skin and 10 the worst imaginable scar or sensation; these items are summed to obtain a total score ranging from 6 to 60 for each scale. In addition to the POSAS score, both observer and patient give their own overall opinion on the appearance of the scar using a 10-point scale.
Measured: up to four weeks
Secondary outcomes (2)
range of motion
the range of motion (wrist, metacarpophalangeal, proximal and disatal interphalangeal joint)will be assessed by kinovea software.Kinovea provides a tool to manually draw lines and measure angles to assess ROM as the following:Pause the video at the point where maximum movement occurs (e.g., maximum wrist flexion).Use the angle tool to draw two lines corresponding to the bones of the joint. The software will calculate the angle between the lines, giving you a measure of the ROM.
Measured: up to four weeks
handgrip strength
The hand dynamometer will be used to assess hand grip strength.The subject grips the dynamometer with their maximum force for a few seconds (typically 3 to 5 seconds).Avoid jerky movements or changes in posture during the measurement.
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start5 Jun 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- instrumented assisted soft tissue mobilization and tradional therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa labib abdalaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009197
- Sponsor's protocol ID
- P.T.REC/012/005611
- Acronym
- IASTM
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument Assisted Soft Tissue Mobilization on Hand Post Surgical Scars in Primary Flexor Tendons Repair in Zone v
- ClinicalTrials.gov ID
- NCT07009197
- Acronym / sponsor ID
- IASTM / P.T.REC/012/005611
- Conditions
- Hand Injuries
- Keywords
- Instrument Assisted Soft Tissue Mobilization, Primary Flexor Tendons Repair, Hand Post Surgical Scars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jun 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 6 Jun 2025 (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.
this study will be conducted to investigate the effect of instrument assisted soft tissue mobilization on hand post surgical scars in primary flexor tendons repair in zone v
Detailed description
The hand plays an important role in independent daily living and in communication with the environment. As the most mobile part of the upper extremity, the hand is actively used in everyday life and professional fields. The flexor tendons of the hand are critical for normal hand function. Injury to these tendons can result in absent finger and wrist flexion, and a subsequent loss of overall hand function. The surgical techniques used to repair these tendons have improved in the past few decades, as have the postoperative rehabilitation protocols. In spite of these advances, flexor tendon repairs continue to be plagued by postoperative scar formation, which limits tendon gliding and prevents a full functional recovery. Many different treatment methods can reduce the trauma and surgical scars. Manual scar treatment is one of these methods. Manual scar therapy to be effective requires applying physiological stimuli adequately to the phase of wound healing. Scar tissue therapy is a treatment for reducing pain and functional limitations, improving pliability, reducing hyper-pigmentation, pruritus, fascial adhesions, to reduce scar thickness and smooth surface area. Instrument assisted soft tissue mobilization (IASTM) is a soft-tissue treatment technique where an instrument is used to provide a mobilizing stimulus to positively affect scar tissue and myofascial adhesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- instrumented assisted soft tissue mobilization and tradional therapy
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue Mobilization, Other: traditional therapyTwenty-one patients will receive instrument-assisted soft tissue mobilization and traditional therapy three times a week for four weeks. |
| traditional therapy | Active comparator | Other: traditional therapyTwenty-one patients will receive traditional therapy three times a week for four weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sex will be included in this research
- Hand scar in zone v
- Age varying from 20 to 40
- Hand scar formed post primary flexor tendons repair
Key exclusion criteria (6 listed)
- Vascular injuries requiring arterial repair
- Soft tissue loss
- Fractures
- Tendon in-juries of other zones
- Preexisting problems such as arthritis limiting joint motion
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 |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilizationthe treatment will start by disinfect the instrument between patients to avoid transfer of infections. It is recommended to disinfect the instrument with intermediate-level disinfectants (e.g. isopropyl alcohol), then wash it with soap and water to remove any residuals of the chemical disinfectant off the instrument. If the tools contacts blood, bodily fluids, mucous membranes, or non-intact skin then disinfecting it with high-level disinfectant should be done .IASTM will be done at 30-60 degrees angle for 40-120 seconds+ radiational therapy | Other | Instrument Assisted Soft Tissue Mobilization |
| traditional therapythe patients will receive traditional therapy in the form of ultrasound, scar massage, and stretching exercises. | Other | Instrument Assisted Soft Tissue Mobilization, traditional therapy |
Primary outcome
scar assessment
Time frame: up to four weeks
Patient and Observer Scar Assessment Scale (POSAS) will be used to assess scar.It consists of two distinct scales: the OSAS and the PSAS. The PSAS consists of six items: scar-related pain, itchiness, colour, stiffness, thickness and irregularity. Each POSAS item has a 10-point scoring system, with 1 representing normal skin and 10 the worst imaginable scar or sensation; these items are summed to obtain a total score ranging from 6 to 60 for each scale. In addition to the POSAS score, both observer and patient give their own overall opinion on the appearance of the scar using a 10-point scale.
2 secondary outcomes
range of motion
Time frame: up to four weeks
handgrip strength
Time frame: up to four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization and traditional therapy in people with Hand Injuries, run by Cairo University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alzahraa labib, master (01010602832, zhraalabib214@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar assessment (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.