Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region

Dual Pathway Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Dose-Response Effects in the Calf-Foot Region: Mechanical and Contextual Contributions

The goal of this clinical trial is to learn how different levels of force applied during instrument-assisted soft tissue manipulation (IASTM), a common rehabilitation treatment, affect muscle and soft tissue function in healthy adults with limited ankle flexibility. The study will also examine whether participant expectations, treatment comfort, and other contextual factors influence treatment outcomes. The main questions it aims to answer are:

Do higher-force and lower-force IASTM treatments produce different changes in ankle flexibility, muscle stiffness, pressure pain sensitivity, walking performance, and jumping ability? How do participant expectations, anxiety, comfort, and treatment perceptions contribute to treatment outcomes?

Researchers will compare a higher-force IASTM treatment to a lower-force IASTM treatment to determine whether force dose influences physical and patient-reported outcomes.

Participants will:

Attend two study visits separated by a washout period of 3-7 days. Receive a lower-force IASTM treatment during one visit and a higher-force IASTM treatment during the other visit, in a randomly assigned order.

Complete questionnaires about expectations, anxiety, treatment comfort, and treatment experience.

Undergo assessments of ankle flexibility, calf muscle stiffness, sensitivity to pressure, walking speed, and lower-body performance before and after each treatment session.

The findings from this study will help researchers better understand how biomechanical and non-biomechanical factors contribute to the effects of soft tissue treatments and may help inform the development of more effective rehabilitation interventions.

Study Overview

• Status: Not yet recruiting
• Conditions: Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
• Intervention / Treatment: Device: quantitative instrument-assisted soft tissue manipulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Loghmani, PhD, PT; Phone Number: 3176910175; Email: mloghman@iu.edu
• Study Contact Backup: Name: Rachael Powell, DPT; Phone Number: 3173061072; Email: racpowel@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Health and Human Sciences
      • Contact: Rachael Powell, DPT; Phone Number: 3173061072; Email: racpowel@iu.edu
      • Contact: Mary T Loghmani, PhD, PT; Phone Number: 3176910175; Email: mloghman@iu.edu
      • Principal Investigator: Mary T Loghmani, PhD, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. Between the ages of 18-50 years old
3. Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2
4. A tight calf with limited ankle dorsiflexion range of motion: < 8-9 cm on weight-bearing lunge test (WBLT) indicating restricted ankle dorsiflexion and/or side to side difference of >1.5 cm due to muscular tightness.

Exclusion Criteria:

1. Any known musculoskeletal pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or inflammatory conditions that may interfere with study participation.
2. Ankle joint limitations due to intra-articular, capsular tightness, or post-fracture abnormalities.
3. Any known cardiovascular, pulmonary, metabolic disease, or other co-morbidities that could interfere with the clinician's ability to perform basic IASTM stroke patterns to the calf or subject participation.
4. Any narcotics, blood thinners, or other medications that could alter sensation, consciousness, or tendency to bruise/bleed.
5. Any recent surgeries, medical conditions, or injuries that could interfere with treatment or ability to participate.
6. Acute injuries, unhealed, acute or unstable conditions.
7. Any known contraindications to instrument-assisted soft tissue manipulation of the lower extremity, including but not limited to open wounds, active infection, unhealed fracture, deep vein thrombosis, severe vascular disorders, bleeding disorders, anticoagulant therapy associated with increased bleeding risk, or other conditions that, in the judgment of the investigator, would make study participation unsafe.
8. Current smoking or recreational/illicit drug use.
9. Individuals who answer "Yes" to any of Questions 1-7 on the Physical Activity Readiness Questionnaire (PAR-Q) will be required to obtain written clearance from their physician or other qualified healthcare provider before participating in study procedures involving physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Higher-force IASTM; Will receive higher-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold	Device: quantitative instrument-assisted soft tissue manipulation; Higher-Force Instrument-assisted soft tissue manipulation (IASTM) is applied to the calf-foot region using a force-sensing research instrument that provides real-time visual feedback to the clinician. A standardized treatment protocol is used, including consistent treatment duration, treatment area, stroke characteristics, and participant positioning. Force is maintained within a predefined higher-force target range based on participant tolerance within their comfort. Lower-Force IASTM is applied to the calf-foot region using the same force-sensing device and standardized treatment protocol. Force is maintained within a predefined lower-force target range to isolate the effects of force dose on study outcomes. The intervention is designed to evaluate force-dose effects while controlling other treatment variables.; Other Names: QSTM
Experimental: Lower-force IASTM; Will receive a lower-force instrument-assisted massage during one study session as randomized based on individualized dynamic pain threshold	Device: quantitative instrument-assisted soft tissue manipulation; Higher-Force Instrument-assisted soft tissue manipulation (IASTM) is applied to the calf-foot region using a force-sensing research instrument that provides real-time visual feedback to the clinician. A standardized treatment protocol is used, including consistent treatment duration, treatment area, stroke characteristics, and participant positioning. Force is maintained within a predefined higher-force target range based on participant tolerance within their comfort. Lower-Force IASTM is applied to the calf-foot region using the same force-sensing device and standardized treatment protocol. Force is maintained within a predefined lower-force target range to isolate the effects of force dose on study outcomes. The intervention is designed to evaluate force-dose effects while controlling other treatment variables.; Other Names: QSTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle dorsiflexion range of motion weight-bearing lunge test (WBLT)	Change in ankle dorsiflexion range of motion measured using the Weight-Bearing Lunge Test (WBLT) immediately following higher-force and lower-force instrument-assisted soft tissue manipulation (IASTM).	Immediately before and after intervention to each leg at each session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calf muscle stiffness	Calf muscle stiffness will be assessed using a handheld tissue stiffness measurement device. Higher values indicate greater resistance of the calf musculature to deformation, whereas lower values indicate reduced tissue stiffness.	Immediately before and after intervention to each leg at each session.
pain pressure threshold	Pressure pain threshold will be assessed using a pressure algometer applied to the calf musculature. The measure represents the minimum pressure at which pressure sensation first becomes painful. Higher values indicate lower pain sensitivity.	Immediately before and after intervention at each session.
Walking speed	Walking speed will be assessed during a standardized walking task and reported as walking velocity. Higher values indicate faster walking performance.	Immediately before and after intervention at each session.
Vertical Jump Performance	Jump height will be recorded using standard equipment, with higher values indicating greater lower-extremity power and performance.	Immediately before and after intervention at each session.
Self-reported Pain Level	Pain intensity will be assessed using an 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores indicate greater pain intensity.	Immediately before and after interventions to each leg at each session.
Self-reported function level	Function level will be assessed using a Visual Analog Scale (VAS), with higher scores indicating greater self-reported function.	Before and after interventions at each session.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Anxiety Level	Anxiety level will be assessed using a Visual Analog Scale (VAS), in which participants rate their current level of anxiety on a continuous scale. Higher scores indicate greater self-reported anxiety.	Immediately prior to intervention at each session.
Treatment Outcome Expectancy	Treatment expectancy will be assessed using a participant-reported questionnaire that measures the extent to which participants expect the higher or lower force intervention to improve mobility, physical performance, and related outcomes. Higher scores indicate greater expectations of treatment benefit.	Immediately prior to first intervention at first session
Treatment Pleasantness Rating	Treatment pleasantness will be assessed using a participant-reported rating of the overall comfort and pleasantness of the intervention experience. Higher scores indicate a more favorable treatment experience.	Immediately following each intervention session.

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• Bhattacharjee A, Anwar S, Chien S, Loghmani MT. A Handheld Quantifiable Soft Tissue Manipulation Device for Tracking Real-Time Dispersive Force-Motion Patterns to Characterize Manual Therapy Treatment. IEEE Trans Biomed Eng. 2023 May;70(5):1553-1564. doi: 10.1109/TBME.2022.3222124. Epub 2023 Apr 20.

Study record dates

Study Major Dates

• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): October 25, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: muscle tightness, massage, calf
• Other Study ID Numbers: 32736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

De-identified individual participant data may be shared with other researchers in accordance with participant consent and institutional policies; however, specific plans for data sharing have not yet been determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes