- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603714
Effects of Soft Tissue Mobilization at Different Muscle Lengths
September 16, 2024 updated by: Matej Voglar, University of Primorska
Immediate Effects of Instrument Assisted Soft Tissue Mobilization at Different Muscle Lengths
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Instrument assisted soft tissue mobilization is a widely used manual therapy technique, which aims at reducing pain and improving range of motion.
Evidence regarding acute responses to instrument assisted soft tissue mobilization at different muscle lengths is lacking.
Therefore, the purpose of our study was to conduct a cross-over trial and compare the acute effects of instrument assisted soft tissue mobilization at short and long muscle lengths of the calf muscles on pain pressure thresholds and measures of flexibility.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Primorska
-
Izola, Primorska, Slovenia, 6310
- University of Primorska, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- without previous lower limb injuries in the last year
- healthy individuals
- students
Exclusion Criteria:
- Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
- General hypermobility: Beighton score >4.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treated segment - stretched
Instrument assisted soft tissue mobilization will be completed with the calf muscles in a shortened position (30° knee flexion and full ankle plantar flexion).
|
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°.
Other Names:
|
|
Experimental: Treated segment - shortened
Instrument assisted soft tissue mobilization will be completed with the calf muscles in a lengthened position (full knee extension and approximately 0° ankle dorsiflexion).
|
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°.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold
Time Frame: 30 minutes
|
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
Time Frame: 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stand and reach test
Time Frame: 30 minutes
|
With the help of a standardized measuring tool, participants will activelly bend as low as possible.
|
30 minutes
|
|
Lumbar spine flexibility
Time Frame: 30 minutes
|
Sagittal profile of the spine will be measured measured via device: Idiag M360 (MediMouse, Idiag AG, Fehraltorf, Switzerland).
End range of motion of the whole lumbar spine was recorded.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 5, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
September 16, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 16, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IASTM_effects
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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