Muscle, Ligament and Fascia DisordersNCT06603714
Effects of Soft Tissue Mobilization at Different Muscle Lengths
A study testing Instrument assisted soft tissue mobilization in people with Muscle, Ligament and Fascia Disorders and Instrument Assisted Soft Tissue Mobilization, run by University of Primorska at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle, Ligament and Fascia Disorders, Instrument Assisted Soft Tissue Mobilization, Range of Motion
- What is being tested?
- Instrument assisted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Oct 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- without previous lower limb injuries in the last year
- healthy individuals
- students
Who cannot join
- Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
- General hypermobility: Beighton score >4.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, Primorska, 6310
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle, Ligament and Fascia Disorders, Instrument Assisted Soft Tissue Mobilization, Range of Motion, Pain
- Being tested
- Instrument assisted soft tissue mobilization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument assisted soft tissue mobilizationOther
Also called Stretching
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°.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Instrument assisted soft tissue mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Secondary outcomes (2)
Stand and reach test
With the help of a standardized measuring tool, participants will activelly bend as low as possible.
Measured: 30 minutes
Lumbar spine flexibility
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Oct 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle, Ligament and Fascia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete two visits. During one visit the treatment will be performed at short, whilst during the other at long muscle lengths.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Voglar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603714
- Sponsor's protocol ID
- IASTM_effects
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Instrument Assisted Soft Tissue Mobilization at Different Muscle Lengths
- ClinicalTrials.gov ID
- NCT06603714
- Acronym / sponsor ID
- IASTM_effects
- Conditions
- Muscle, Ligament and Fascia Disorders, Instrument Assisted Soft Tissue Mobilization, Range of Motion, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will complete two visits. During one visit the treatment will be performed at short, whilst during the other at long muscle lengths.
| Arm | Type | Receives |
|---|---|---|
| Treated segment - stretched | Experimental | Other: Instrument assisted soft tissue mobilizationInstrument assisted soft tissue mobilization will be completed with the calf muscles in a shortened position (30° knee flexion and full ankle plantar flexion). |
| Treated segment - shortened | Experimental | Other: Instrument assisted soft tissue mobilizationInstrument assisted soft tissue mobilization will be completed with the calf muscles in a lengthened position (full knee extension and approximately 0° ankle dorsiflexion). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- without previous lower limb injuries in the last year
- healthy individuals
- students
Key exclusion criteria (2 listed)
- Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
- General hypermobility: Beighton score >4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument assisted soft tissue mobilizationAlso: StretchingWe 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 | Treated segment - shortened, Treated segment - stretched |
Primary outcome
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.
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.
2 secondary outcomes
Stand and reach test
Time frame: 30 minutes
Lumbar spine flexibility
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument assisted soft tissue mobilization in people with Muscle, Ligament and Fascia Disorders and Instrument Assisted Soft Tissue Mobilization, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.