Trigger Point Pain, MyofascialNCT04136197
Trigger Point Incidence After Lumbar Disc Herniation Surgery
An observational study of Trigger Point Pain, Myofascial, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Manual palpation for incidence determination
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2020to 1 Jul 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients having lumbar disc herniation surgery
Who may be able to join
- To be between 30-70 years
- To have low back pain during minimum 6 weeks
- To be voluntary participation for this study
- To approve the informed consent form
- To have the trigger point causing low back pain on muscles including quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus minimus, gluteus medius, ve piriformis muscles.
Who cannot join
- To be diagnosed with spinal stenosis or spondylolisthesis
- To have any skin problem affecting lower extremity evaluation
- To have tumor on spinal region
- To have rheumatological or any systemic problem that may interfere with trigger point diagnose
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34740
About this study
Official title: The Determination of the Trigger Point Incidence After Lumbar Disc Herniation Surgery
Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery.
Read the detailed description
The 110 participants between 30-70 years are chosen from patients who had lumbar disc herniation surgery. The trigger points are determined by manually palpating quadratus lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve piriformis muscles before and after surgery. Data will be recorded on the patient assessment file and transferred to the computer and analyzed. Data analysis will be performed with SPSS.20.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Manual palpation for incidence determination
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual palpation for incidence determinationDiagnostic test
The patients are positioned in a sitting and prone lying posture. Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Palpation
The patients are positioned in a sitting and prone lying posture.Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
Measured: Change from baseline (preoperative state) to postoperative first and third day
Visual Analog Scale
Pain will be assessed with Visual Analog Scale (VAS).The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side.The patient was asked to mark the line point that represented his or her current pain.
Measured: Change from baseline (preoperative state) to postoperative first and third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start18 Jul 2020
- Primary completion1 Feb 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Masoud Amir Rashedi Bonab, MSc., Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136197
- Sponsor's protocol ID
- Istanbul University-Cerrahpasa
- Status last verified
- Aug 2021
- First submitted
- 21 Oct 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kadi F, Waling K, Ahlgren C, Sundelin G, Holmner S, Butler-Browne GS, Thornell LE. Pathological mechanisms implicated in localized female trapezius myalgia. Pain. 1998 Dec;78(3):191-196. doi: 10.1016/S0304-3959(98)00126-2.
PubMed 9870572
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the Trigger Point Incidence After Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT04136197
- Acronym / sponsor ID
- Istanbul University-Cerrahpasa
- Conditions
- Trigger Point Pain, Myofascial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 18 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Oct 2019 (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.
Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery.
Detailed description
The 110 participants between 30-70 years are chosen from patients who had lumbar disc herniation surgery. The trigger points are determined by manually palpating quadratus lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve piriformis muscles before and after surgery. Data will be recorded on the patient assessment file and transferred to the computer and analyzed. Data analysis will be performed with SPSS.20.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients having lumbar disc herniation surgery
Key inclusion criteria (5 listed)
- To be between 30-70 years
- To have low back pain during minimum 6 weeks
- To be voluntary participation for this study
- To approve the informed consent form
- To have the trigger point causing low back pain on muscles including quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus minimus, gluteus medius, ve piriformis muscles.
Key exclusion criteria (4 listed)
- To be diagnosed with spinal stenosis or spondylolisthesis
- To have any skin problem affecting lower extremity evaluation
- To have tumor on spinal region
- To have rheumatological or any systemic problem that may interfere with trigger point diagnose
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 |
|---|---|---|
| Manual palpation for incidence determinationThe patients are positioned in a sitting and prone lying posture. Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response. | Diagnostic test | – |
Primary outcome
Manual Palpation
Time frame: Change from baseline (preoperative state) to postoperative first and third day
The patients are positioned in a sitting and prone lying posture.Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
Visual Analog Scale
Time frame: Change from baseline (preoperative state) to postoperative first and third day
Pain will be assessed with Visual Analog Scale (VAS).The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side.The patient was asked to mark the line point that represented his or her current pain.
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 25 Aug 2021.
- Results publication: PubMed 9870572Kadi F, Waling K, Ahlgren C, Sundelin G, Holmner S, Butler-Browne GS, Thornell LE. Pathological mechanisms implicated in localized female trapezius myalgia. Pain. 1998 Dec;78(3):191-196. doi: 10.1016/S0304-3959(98)00126-2.
- Pathological mechanisms implicated in localized female trapezius myalgia.Link provided by the sponsor.
- 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.
Masoud Amir Rashedi Bonab, MSc. study director
Bahçeşehir University
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 Trigger Point Pain, Myofascial, run by Istanbul University - Cerrahpasa 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 5 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 25 Aug 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?
Manual Palpation (time frame: Change from baseline (preoperative state) to postoperative first and third day). 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?
On the ClinicalTrials.gov record for NCT04136197, which also lists 1 linked publication.
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 25 Aug 2021.