NCT07009197

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 5, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 29, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

Instrument Assisted Soft Tissue MobilizationPrimary Flexor Tendons RepairHand Post Surgical Scars

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to four weeks

Secondary Outcomes (2)

  • range of motion

    up to four weeks

  • handgrip strength

    up to four weeks

Study Arms (2)

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.

Other: Instrument Assisted Soft Tissue MobilizationOther: traditional therapy

traditional therapy

ACTIVE COMPARATOR

Twenty-one patients will receive traditional therapy three times a week for four weeks.

Other: traditional therapy

Interventions

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

Instrument Assisted Soft Tissue Mobilization

the patients will receive traditional therapy in the form of ultrasound, scar massage, and stretching exercises.

Instrument Assisted Soft Tissue Mobilizationtraditional therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

alzahraa labib, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: instrumented assisted soft tissue mobilization and tradional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : alzahraa labib abdalziz

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

June 5, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

June 6, 2025

Record last verified: 2025-05