NCT06613022

Brief Summary

The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy adult volunteers. The main questions it aims to answer are:

  • Does IASTM treatment have an effect on range of motion (ROM) as measured in the elbow, wrist and thumb?
  • Does IASTM treatment have an effect on grip strength? Researchers will compare pre-test and post-test IASTM treatment intervention data to the pre-test and post-test data of the no treatment control intervention to see if IASTM works to change ROM and/or grip strength. Participants will:
  • Complete a questionnaire on medical history and injury background
  • Have elbow, wrist, and thumb range of motion (ROM) measurements taken on both upper extremities using a goniometer
  • Undergo grip strength testing using a JAMAR hand dynamometer in three positions on both upper extremities
  • Be randomly assigned to either IASTM first treatment group or the wait/control first group
  • Receive IASTM treatment techniques including application of emollient to the skin to reduce friction on the surface followed by scanning the forearm wrist flexors and wrist extensors and the biceps and triceps using the HG8-Scanner tool and then the concave tool corresponding to the size of the structure being treated will be used (HG6-Large Multi-Curve, HG5-Medium Multi-Curve, HG4-Small Multi-Curve) in each direction for a total treatment time of 20 minutes for both upper extremities in all listed areas.
  • Simply wait for 20 minutes (the duration of time treatment with IASTM would require) when assigned to the control group.
  • Complete elbow, wrist and thumb range of motion and grip strength measurement testing at the end of the first session.
  • Return within fourteen days after the first session in order to undergo the opposite experience (IASTM first means wait/control second and vice versa).
  • Undergo the same baseline pre-test measurements for range of motion and grip strength as the first session.
  • Experience the opposite treatment group for the same time period as the first session.
  • Undergo the post-test range of motion and grip strength testing at the end of the second session for data comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 18, 2024

Last Update Submit

September 23, 2024

Conditions

Keywords

Instrument Assisted Soft Tissue MobilizationRange of MotionGrip Strength

Outcome Measures

Primary Outcomes (2)

  • Range of Motion

    Bilateral elbow flexion and extension, wrist flexion, extension, ulnar deviation and radial deviation as well as thumb flexion, abduction and extension range of motion measurements were taken in sitting using a goniometer.

    From baseline to end of session at one hour

  • Grip Strength

    Grip strength was assessed bilaterally using a JAMAR hand dynamometer. Three positions were tested. First the participant flexed their shoulder to 90 degrees with the elbow kept straight. Then the participant kept their arm down and their side with the elbow bent to 90 degrees. Finally the participant kept their arm down and straightened the elbow. Three trials were used for each position.

    From baseline to end of session at one hour

Study Arms (2)

IASTM First

EXPERIMENTAL

This arm of the study received IASTM treatment on the first day and the wait/control on the second day of the study.

Other: Instrument Assisted Soft Tissue Mobilization first Control second

Wait/control First

EXPERIMENTAL

This arm of the study waited (was the control) on the first day and received IASTM treatment on the second day of the study.

Other: Control first Instrument Assisted Soft Tissue Mobilization second

Interventions

Instrument assisted soft tissue mobilization was utilized first on day one and wait-control was completed on second day.

IASTM First

This intervention involved waiting for 20 minutes between pre-test and post-test on day one and having Instrument Assisted Soft Tissue Mobilization on day two.

Wait/control First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A volunteer from a small regional university student body, faculty or staff may participate.

You may not qualify if:

  • Acute spinal cord injury with neurological deficits
  • Neurological disorders
  • Acute upper extremity injury such as sprain or strain
  • Any type of upper extremity fracture within the past 12 months
  • Cervical disc pathology with radicular symptoms
  • Use of blood thinning or clotting medications
  • Known connective tissue disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minot State University

Minot, North Dakota, 58707, United States

Location

Study Officials

  • Beth Marschner, DPT

    Minot State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 25, 2024

Study Start

January 8, 2024

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The individual participant data is not the main focus of this study. The overall findings of the study with the larger number of participants to look at the trend is what will be shared (presented or published). The IRB proposal for this study included confidentiality of each individual participant as that will be maintained, but the global findings are what will be shared after data analysis for comparison.

Locations