NCT07031193

Brief Summary

Foam rolling (FR) is a common tool and procedure used in rehabilitation. Previous research has demonstrated physical improvements in range of motion and subjective reductions in pain post-intervention. Most of the literature theorizes potential biophysical reasons for these changes, but definitive studies are lacking. Another potential mechanism for these improvements may be psychological. The purpose of this study is to explore the psychological changes that occur in response to the instructions given to the patient and how these may influence the outcomes the individual receives while undergoing FR. Different instructions will be given for the same technique of FR to see if there are differences in changes with pain and range of motion.

Trial Health

63
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Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress92%
Aug 2025May 2026

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

July 2, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 12, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

foam roller,range of motionpain

Outcome Measures

Primary Outcomes (2)

  • Straight leg raise Range of motion on dominate leg

    Hamstring range of motion is measured with a standard goniometer on the dominant leg (the leg you would prefer to kick a ball with). Participant lying supine, the examiner assists with raising the leg straight (knee at 0 degrees extension) at the hip into flexion. Measure maximal hip flexion, with no change in knee extension, posterior pelvic tilt, or lumbar spine flexion. Goniometric measurements of hamstring length will then be measured with the stationary arm in line with the lateral midline of the pelvis, the axis of the goniometer will be placed on the greater trochanter of the hip, and the movement arm will be lined up with the midline of the lateral femur to the lateral epicondyle of the ipsilateral knee.

    from enrollment to the end of the session at 1 day

  • Pain pressure threshold of the hamstring muscle group

    Use of a handheld algometer to assess pain pressure threshold. Application of pressure at the middle point of the hamstring on the dominant leg (the leg you would prefer to kick a ball with). The middle point is determined by the midway point measured from the ischial tuberosity and the knee joint line. Pressure is applied at a steady rate until the participant reports that the sensation of pressure changes from pressure to pain. Measurement in kg/cm2 will be recorded and the average of three measurements will be recorded.

    from enrollment to the end of the session at 1 day

Study Arms (2)

ROM

ACTIVE COMPARATOR

Foam rolling with instructions related to pain reduction

Procedure: Foam roller instructions for pain reductionProcedure: Foam rolling for range of motion improvement

Pain

ACTIVE COMPARATOR

Foam rolling with Pain reduction instructions

Procedure: Foam roller instructions for pain reductionProcedure: Foam rolling for range of motion improvement

Interventions

Foam rolling procedure with pain reduction instructions over hamstring muscle group

PainROM

Foam rolling over hamstring muscle group with range of motion improvement instructions.

PainROM

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fluent in English and primary language

You may not qualify if:

  • Current musculoskeletal injury of the lower limbs for which they are receiving medical care.
  • Recent surgery to the lower limbs that has not been fully released for full participation by a medical provider.
  • Use of any pain-relieving medications within the last 24 hours.
  • Any medical condition that limits their perception of pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Dakota

Vermillion, South Dakota, 57069, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kory Zimney, DPT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

July 2, 2025

Record last verified: 2025-07

Locations