Trigger PointsNCT05554887
Effect of Thoracic Manipulation on Latent Trigger Point
A study testing Thrust manipulation in people with Trigger Points, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of one session thoracic manipulation on pressure pain threshold and rhomboid muscle strength in healthy individuals with latent trigger point. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Thrust manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2022to 12 Dec 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not having any systemic disease
- not having any neuromuscular deficit
- To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine
Who cannot join
- Being actively involved in any sport
- Participating in a regular exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Manipulation on Muscle Strength and Pressure Pain Threshold in Healthy Individuals With Rhomboid Latent Trigger Point: A Randomized Sham Controlled Study.
The aim of this study is to investigate the effect of one session thoracic manipulation on pressure pain threshold and rhomboid muscle strength in healthy individuals with latent trigger point.
Read the detailed description
Within the scope of the study, all individuals studying at Sarayköy Vocational School and volunteering to participate in the study will be screened.Immediately after determining the latent trigger points in the rhomboid muscles, the participants will be randomized by computer method and divided into 2 groups. Participants who underwent thrust thoracic manipulation will form the study group, and participants who received sham thrust thoracic manipulation will form the control group.Pressure pain threshold will be evaluated with an algometer and rhomboid muscle strength will be evaluated with a hand dynamometer.
- Conditions
- Trigger Points
- Being tested
- Thrust manipulation, Sham thrust manipulation
- Keywords
- latent trigger point, thorasic manipulation, muscle strength, pressure pain threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust manipulationOther
Participants will be positioned prone and the clinician will perform a high-speed, low-amplitude thrust into the most symptomatic segment of the thoracic spine. TM type, thrust direction, and number of thrusts will be at the clinician's discretion and will be based on the individualized assessment of the patient.
Sham thrust manipulationOther
The same protocol will be applied as the push thoracic manipulation application, but no push will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Thrust manipulation Group | Experimental | Participants undergoing thrust manipulation Receives: Other: Thrust manipulation |
| Sham thrust manipulation group | Sham comparator | Participants undergoing sham thrust manipulation Receives: Other: Sham thrust manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold
assessed with algometer
Measured: up to 3 months
rhomboid muscle strength
assessed with hand held dynamometer
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start11 Oct 2022
- Primary completion1 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trigger PointsStudies 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
- Parallel groups
- Model description
- randomised sham controlled study involving 2 parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şule ŞİMŞEK, Pamukkale University
- Investigators
- Şule Şimşek, Phd, Study director, Phd faculty member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554887
- Sponsor's protocol ID
- 26.07.2022/11
- Status last verified
- Dec 2022
- First submitted
- 16 Sep 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanney WJ, Puentedura EJ, Kolber MJ, Liu X, Pabian PS, Cheatham SW. The immediate effects of manual stretching and cervicothoracic junction manipulation on cervical range of motion and upper trapezius pressure pain thresholds. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1005-1013. doi: 10.3233/BMR-169573.
PubMed 28505955The effect of lower cervical and upper thoracic spinal manipulative therapy on pressure algometer readings of rhomboid and infraspinatus muscles by influencing the fascial tension of the spiral line: Doctoral dissertation, Johannesburg: University of Johannesburg, 2015.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Manipulation on Muscle Strength and Pressure Pain Threshold in Healthy Individuals With Rhomboid Latent Trigger Point: A Randomized Sham Controlled Study.
- ClinicalTrials.gov ID
- NCT05554887
- Acronym / sponsor ID
- 26.07.2022/11
- Conditions
- Trigger Points
- Keywords
- latent trigger point, thorasic manipulation, muscle strength, pressure pain threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 26 Sep 2022 (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 aim of this study is to investigate the effect of one session thoracic manipulation on pressure pain threshold and rhomboid muscle strength in healthy individuals with latent trigger point.
Detailed description
Within the scope of the study, all individuals studying at Sarayköy Vocational School and volunteering to participate in the study will be screened.Immediately after determining the latent trigger points in the rhomboid muscles, the participants will be randomized by computer method and divided into 2 groups. Participants who underwent thrust thoracic manipulation will form the study group, and participants who received sham thrust thoracic manipulation will form the control group.Pressure pain threshold will be evaluated with an algometer and rhomboid muscle strength will be evaluated with a hand dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised sham controlled study involving 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Thrust manipulation Group | Experimental | Other: Thrust manipulationParticipants undergoing thrust manipulation |
| Sham thrust manipulation group | Sham comparator | Other: Sham thrust manipulationParticipants undergoing sham thrust manipulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- not having any systemic disease
- not having any neuromuscular deficit
- To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine
Key exclusion criteria (2 listed)
- Being actively involved in any sport
- Participating in a regular exercise program
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 |
|---|---|---|
| Thrust manipulationParticipants will be positioned prone and the clinician will perform a high-speed, low-amplitude thrust into the most symptomatic segment of the thoracic spine. TM type, thrust direction, and number of thrusts will be at the clinician's discretion and will be based on the individualized assessment of the patient. | Other | Thrust manipulation Group |
| Sham thrust manipulationThe same protocol will be applied as the push thoracic manipulation application, but no push will be applied. | Other | Sham thrust manipulation group |
Primary outcome
pressure pain threshold
Time frame: up to 3 months
assessed with algometer
rhomboid muscle strength
Time frame: up to 3 months
assessed with hand held dynamometer
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 28 Dec 2022.
- Background: PubMed 28505955Hanney WJ, Puentedura EJ, Kolber MJ, Liu X, Pabian PS, Cheatham SW. The immediate effects of manual stretching and cervicothoracic junction manipulation on cervical range of motion and upper trapezius pressure pain thresholds. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1005-1013. doi: 10.3233/BMR-169573.
- BackgroundThe effect of lower cervical and upper thoracic spinal manipulative therapy on pressure algometer readings of rhomboid and infraspinatus muscles by influencing the fascial tension of the spiral line: Doctoral dissertation, Johannesburg: University of Johannesburg, 2015.
- 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.
Şule Şimşek, Phd study director
Phd faculty member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust manipulation in people with Trigger Points, run by Pamukkale University 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 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: finished, as of the sponsor's last update on 28 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
pressure pain threshold (time frame: up to 3 months). 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 NCT05554887, which also lists 2 linked publications.
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 28 Dec 2022.