NCT06603714

Brief Summary

The purpose of this study will be to compare the effects of instrument assisted soft tissue mobilization at different muscle lengths on pain pressure thresholds and measures of flexibility.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

October 5, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

27 days

First QC Date

September 16, 2024

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain pressure threshold

    Pain pressure threshold will be measured via handheld algometer on the proximal third of the distance between medial condyle of the femur and lateral malleolus.

    30 minutes

  • Passive dorsiflexion range of motion

    Passive dorsiflexion will be measured via two wooden boards connected with a hinge. We will apply a standardized torque of 30,9 Nm via handheld dynamometer. Each visit, participants will be measured before and after the performed intervention.

    30 minutes

Secondary Outcomes (2)

  • Stand and reach test

    30 minutes

  • Lumbar spine flexibility

    30 minutes

Study Arms (2)

Treated segment - stretched

EXPERIMENTAL

Instrument assisted soft tissue mobilization will be completed with the calf muscles in a shortened position (30° knee flexion and full ankle plantar flexion).

Other: Instrument assisted soft tissue mobilization

Treated segment - shortened

EXPERIMENTAL

Instrument assisted soft tissue mobilization will be completed with the calf muscles in a lengthened position (full knee extension and approximately 0° ankle dorsiflexion).

Other: Instrument assisted soft tissue mobilization

Interventions

We will perform instrument assisted soft tissue mobilization on calf muscles. The intervention will last 9 min. For the first minute of treatment light pressure will be applied for tissue preparation. Afterwards, four different strokes will be applied by maintaining the tool at a 30° of inclination for one minute. This will be repeated for a second set, with a tool inclination of 45°.

Also known as: Stretching
Treated segment - shortenedTreated segment - stretched

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • without previous lower limb injuries in the last year
  • healthy individuals
  • students

You may not qualify if:

  • Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
  • General hypermobility: Beighton score \>4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, Primorska, 6310, Slovenia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant will complete two visits. During one visit the treatment will be performed at short, whilst during the other at long muscle lengths.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

October 5, 2024

Primary Completion

November 1, 2024

Study Completion

November 15, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations