Myofascial Pain SyndromeNCT04640558
Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects
An observational study of Myofascial Pain Syndrome and Muscle Weakness, run by Kars State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the relationship between latent MTrPs and gluteus medius muscle strength in a group of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Myofascial Pain Syndrome, Muscle Weakness
- What is being tested?
- Muscle strength measurement
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2020to 17 Jan 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 40 years
- Men only
- Adult
Study population: 24 participants who are clinically diagnosed with unilateral latent MTrP in the dominant side gluteus medius muscle and 24 participants who don't have latent MTrP.
Who may be able to join
- Patient age: 18-40 years.
- Absence of musculoskeletal complaints related to the lumbar, sacroiliac, and hip area.
- Absence of bilateral latent MTrP in the gluteus medius muscle.
- Latent trigger point in the gluteus medius muscle on the dominant side with palpation.
Who cannot join
- A history of medical treatment, physical therapy, injection therapy, or surgical treatment related to the lumbar, sacroiliac, and hip area.
- History of trauma, or malignancy or being pregnant, or if the patient is in the lactation period.
- Bilateral latent MTrP in the gluteus medius muscle.
- Presence of latent MTrP on the non-dominant side.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University Faculty of Medicine
Istanbul, 34100
About this study
Official title: The Relationship Between Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects
This study aimed to investigate the relationship between latent MTrPs and gluteus medius muscle strength in a group of healthy adults.
Read the detailed description
Latent myofascial trigger points (MTrPs) do not cause spontaneous pain; however, they may lead to a limited range of motion and muscle weakness. We hypothesized that latent MTrPs might decrease gluteus medius muscle strength in healthy individuals. Forty-eight healthy men will be included in the study. Trigger point examination for the gluteus medius will be performed bilaterally. Subjects with one or more trigger points on the dominant side and those without any trigger points will be assigned to two groups. Muscle strength for gluteus medius will be assessed with a manual muscle tester using the "break test" technique on both sides. The subjects and the examiners will be blinded. For statistical analysis, the independent sample t-test was used to compare the intergroup differences.
- Conditions
- Myofascial Pain Syndrome, Muscle Weakness
- Being tested
- Muscle strength measurement
- Keywords
- Trigger point, Gluteus medius muscle
- Medical subject headings
- Myofascial Pain Syndromes, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength measurementDevice
The bilateral gluteus medius muscle strength of each participant will be measured by the assessor (MB) blinded to the participants using the Lafayette manual muscle tester. (Lafayette Instrument Company, Lafayette IN, USA). In the participant's side-lying position, the practitioner applied resistance from the upper ankle to the abduction movement with slight flexion of the upper hip. During the measurements, the participants were asked to perform the maximum isometric contraction for 3 seconds. Gluteus medius muscle strength measurements were repeated three times, one minute apart, on the right and left sides. The mean of the measurements was calculated and recorded
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Latent Myofascial Trigger Point Group | 24 participants who will be clinically diagnosed with unilateral latent myofascial trigger point in the dominant side gluteus medius muscle. Receives: Device: Muscle strength measurement | |
| Group 2. Non-Latent Myofascial Trigger Point Group | 24 participants who don't have latent myofascial trigger point. Receives: Device: Muscle strength measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluteus medius muscle strength
In the participant's side-lying position, the practitioner will be applied resistance from the upper ankle to the abduction movement with slight flexion of the upper hip. During the measurements, the participants will be asked to perform the maximum isometric contraction for 3 seconds. Gluteus medius muscle strength measurements will be repeated three times, one minute apart, on the right and left sides. The mean of the measurements will be calculated and recorded
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start17 Nov 2020
- Primary completion17 Jan 2021
- Study completion17 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640558
- Sponsor's protocol ID
- KarsSH
- Status last verified
- Jan 2021
- First submitted
- 17 Nov 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04640558
- Acronym / sponsor ID
- KarsSH
- Conditions
- Myofascial Pain Syndrome, Muscle Weakness
- Keywords
- Trigger point, Gluteus medius muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 17 Jan 2021 (actual)
- First posted
- 23 Nov 2020 (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.
This study aimed to investigate the relationship between latent MTrPs and gluteus medius muscle strength in a group of healthy adults.
Detailed description
Latent myofascial trigger points (MTrPs) do not cause spontaneous pain; however, they may lead to a limited range of motion and muscle weakness. We hypothesized that latent MTrPs might decrease gluteus medius muscle strength in healthy individuals. Forty-eight healthy men will be included in the study. Trigger point examination for the gluteus medius will be performed bilaterally. Subjects with one or more trigger points on the dominant side and those without any trigger points will be assigned to two groups. Muscle strength for gluteus medius will be assessed with a manual muscle tester using the "break test" technique on both sides. The subjects and the examiners will be blinded. For statistical analysis, the independent sample t-test was used to compare the intergroup differences.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. Latent Myofascial Trigger Point Group | – | Device: Muscle strength measurement24 participants who will be clinically diagnosed with unilateral latent myofascial trigger point in the dominant side gluteus medius muscle. |
| Group 2. Non-Latent Myofascial Trigger Point Group | – | Device: Muscle strength measurement24 participants who don't have latent myofascial trigger point. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- 24 participants who are clinically diagnosed with unilateral latent MTrP in the dominant side gluteus medius muscle and 24 participants who don't have latent MTrP.
Key inclusion criteria (4 listed)
- Patient age: 18-40 years.
- Absence of musculoskeletal complaints related to the lumbar, sacroiliac, and hip area.
- Absence of bilateral latent MTrP in the gluteus medius muscle.
- Latent trigger point in the gluteus medius muscle on the dominant side with palpation.
Key exclusion criteria (4 listed)
- A history of medical treatment, physical therapy, injection therapy, or surgical treatment related to the lumbar, sacroiliac, and hip area.
- History of trauma, or malignancy or being pregnant, or if the patient is in the lactation period.
- Bilateral latent MTrP in the gluteus medius muscle.
- Presence of latent MTrP on the non-dominant side.
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 |
|---|---|---|
| Muscle strength measurementThe bilateral gluteus medius muscle strength of each participant will be measured by the assessor (MB) blinded to the participants using the Lafayette manual muscle tester. (Lafayette Instrument Company, Lafayette IN, USA). In the participant's side-lying position, the practitioner applied resistance from the upper ankle to the abduction movement with slight flexion of the upper hip. During the measurements, the participants were asked to perform the maximum isometric contraction for 3 seconds. Gluteus medius muscle strength measurements were repeated three times, one minute apart, on the right and left sides. The mean of the measurements was calculated and recorded | Device | Group 1. Latent Myofascial Trigger Point Group, Group 2. Non-Latent Myofascial Trigger Point Group |
Primary outcome
Gluteus medius muscle strength
Time frame: One month
In the participant's side-lying position, the practitioner will be applied resistance from the upper ankle to the abduction movement with slight flexion of the upper hip. During the measurements, the participants will be asked to perform the maximum isometric contraction for 3 seconds. Gluteus medius muscle strength measurements will be repeated three times, one minute apart, on the right and left sides. The mean of the measurements will be calculated and recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Myofascial Pain Syndrome and Muscle Weakness, run by Kars State Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gluteus medius muscle strength (time frame: One month). 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 29 Jan 2021.