Trigger Point Pain, MyofascialNCT04823013

Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for Treatment of Trigger Points

A study testing high power pain threshold ultrasound which the dose was kept constant, high power pain threshold ultrasound which the dose reduced to one half and ischemic compression in people with Trigger Point Pain, Myofascial, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Trigger Point Pain, Myofascial
What is being tested?: high power pain threshold ultrasound which the dose was kept constant, high power pain threshold ultrasound which the dose reduced to one half and ischemic compression
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2017to 1 Apr 2018
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

being aged between 18-50
the presence of a minimum of 3 latent trigger points in Upper Trapezius, Levator Scapulae, Supraspinatus, Infraspinatus, Deltoid Anterior, Pectoralis Major, Pectoralis Minor muscles
no health problems
signed the voluntary consent form

Who cannot join

have a neck, spine or shoulder injury in the last 6 months
continued neck and back pain in the last 6 months
having a skin disease that may affect upper extremity assessment
malign and benign tumors
pain relief medication
having psychiatric treatment. -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Aydın University
Istanbul, Halit Aydın Kampüsü No:38 Küçükçekmece

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for the Treatment of Latent Myofascial Trigger Points: A Randomized Controlled Study

This study aimed to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on latent trigger point treatment. Asymptomatic subjects divided into three groups. First group took high power pain threshold ultrasound in which the intensity is kept constant at the pain level; second group took high power pain threshold ultrasound which the intensity is kept constant at half the pain level and third group took ischemic compression. All participants were asked to complete the questionnaires, which assessed pain, psychological factors and disability before treatment, after 1 week and 1 month follow-up. After each participants completed the questionnaire, the physical therapist evaluated the MTrPs. MTrPs assessment was performed before treatment, immediately after treatment, after 1 week and 1 month follow-up.

Read the detailed description

Myofascial trigger points have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena. The treatment techniques aimed to return the fiber groups affected by myofascial trigger points to their normal length and endplates to their normal function. Although both ischemic compression and two different application methods of high power pain threshold ultrasound techniques are effective methods in the treatment of trigger points , there are no studies showing which technique is more effective. It is aimed to to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on myofascial trigger point treatment.

Conditions: Trigger Point Pain, Myofascial
Being tested: high power pain threshold ultrasound which the dose was kept constant, high power pain threshold ultrasound which the dose reduced to one half, ischemic compression
Keywords: high power pain threshold ultrasound, ischemic compression, pain, trigger points, pain pressure threshold
Medical subject headings: Myofascial Pain Syndromes, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high power pain threshold ultrasound which the dose was kept constantOther
Participants in HPPT-US 1 group received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².
high power pain threshold ultrasound which the dose reduced to one halfOther
Participants in HPPT-US 2 group also received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².
ischemic compressionOther
Participants in IC group received ischemic compression therapy. The technique was applied in the sitting position to participants. Ischemic compression was performed by compressing trigger points identified by palpation with tolerable intensity using thumb. The duration for each trigger points was 1 minute. Then the muscle containing the trigger point was applied intramuscular stretching for 30 seconds by therapist

Study groups in NCT04823013
Study group	Role	What they receive
high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)	Experimental	Participants in HPPT-US 1 group received one session of HPPT-US treatment which the dose was kept constant. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief. Receives: Other: high power pain threshold ultrasound which the dose was kept constant
high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)	Experimental	Participants in HPPT-US 2 group received one session of HPPT-US treatment which the dose reduced to one half. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief. Receives: Other: high power pain threshold ultrasound which the dose reduced to one half
ischemic compression group	Experimental	Participants in IC group received one session of ischemic compression therapy. Ischemic compression is a therapy technique used in manual therapy, where blockage of blood in an area of the body is deliberately made, so that a resurgence of local blood flow will occur upon release. Receives: Other: ischemic compression

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Measured: Pain intensity was measured using visual analog scale (VAS) before the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Measured: Depression was assessed using the Beck Depression Inventory (BDI) before the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Neck Pain and Disability Scale
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Measured: Disability was evaluated by Neck Pain and Disability Scale (NPAD) before the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
Myofascial trigger points assessment
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Measured: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated before treatment. PPT is a safe outcome measure to evaluate pain sensitivity.
Myofascial trigger points assessment
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Measured: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated immediately after the treatment.
Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Measured: Pain intensity was measured using visual analog scale (VAS) at one week after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Measured: Depression was assessed using the Beck Depression Inventory (BDI) at one week after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Neck Pain and Disability Scale
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Measured: Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one week after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
Myofascial trigger points assessment
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Measured: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one week after the treatment.
Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Measured: Pain intensity was measured using visual analog scale (VAS) at one month after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Measured: Depression was assessed using the Beck Depression Inventory (BDI) at one month after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Neck Pain and Disability Scale
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Measured: Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one month after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
Myofascial trigger points assessment
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Measured: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one month after the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20171 Apr 2018

First posted30 Mar 2021
Study start1 Oct 2017
Primary completion1 Apr 2018
Study completion1 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
More trials run by Gazi UniversityThe sponsor's other registered studies.
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: Participants in HPPT-US 1 group received the HPPT-US treatment (n=52). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. Participants in HPPT-US 2 group also received the HPPT-US treatment (n=57). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times.Participants in IC group received ischemic compression therapy (n=44). The duration for each trigger points was 1 minute.
Masking: Single blind
Who is masked: Participant
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04823013
Sponsor's protocol ID: B.30.2.AYD
Status last verified: Mar 2021
First submitted: 24 Mar 2021
Last updated: 30 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
PubMed 11871683
Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature. J Manipulative Physiol Ther. 2009 Jan;32(1):14-24. doi: 10.1016/j.jmpt.2008.06.012.
PubMed 19121461
Unalan H, Majlesi J, Aydin FY, Palamar D. Comparison of high-power pain threshold ultrasound therapy with local injection in the treatment of active myofascial trigger points of the upper trapezius muscle. Arch Phys Med Rehabil. 2011 Apr;92(4):657-62. doi: 10.1016/j.apmr.2010.11.030.
PubMed 21440713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trigger Point Pain, Myofascial trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for the Treatment of Latent Myofascial Trigger Points: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT04823013
Acronym / sponsor ID: B.30.2.AYD
Conditions: Trigger Point Pain, Myofascial
Keywords: high power pain threshold ultrasound, ischemic compression, pain, trigger points, pain pressure threshold
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 1 Apr 2018 (actual)
Study completion: 1 Apr 2018 (actual)
First posted: 30 Mar 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Participants in HPPT-US 1 group received the HPPT-US treatment (n=52). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. Participants in HPPT-US 2 group also received the HPPT-US treatment (n=57). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times.Participants in IC group received ischemic compression therapy (n=44). The duration for each trigger points was 1 minute.

Arm	Type	Receives
high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)	Experimental	Other: high power pain threshold ultrasound which the dose was kept constantParticipants in HPPT-US 1 group received one session of HPPT-US treatment which the dose was kept constant. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief.
high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)	Experimental	Other: high power pain threshold ultrasound which the dose reduced to one halfParticipants in HPPT-US 2 group received one session of HPPT-US treatment which the dose reduced to one half. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief.
ischemic compression group	Experimental	Other: ischemic compressionParticipants in IC group received one session of ischemic compression therapy. Ischemic compression is a therapy technique used in manual therapy, where blockage of blood in an area of the body is deliberately made, so that a resurgence of local blood flow will occur upon release.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

being aged between 18-50
the presence of a minimum of 3 latent trigger points in Upper Trapezius, Levator Scapulae, Supraspinatus, Infraspinatus, Deltoid Anterior, Pectoralis Major, Pectoralis Minor muscles
no health problems
signed the voluntary consent form

Key exclusion criteria (6 listed)

have a neck, spine or shoulder injury in the last 6 months
continued neck and back pain in the last 6 months
having a skin disease that may affect upper extremity assessment
malign and benign tumors
pain relief medication

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
high power pain threshold ultrasound which the dose was kept constantParticipants in HPPT-US 1 group received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².	Other	high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)
high power pain threshold ultrasound which the dose reduced to one halfParticipants in HPPT-US 2 group also received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².	Other	high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)
ischemic compressionParticipants in IC group received ischemic compression therapy. The technique was applied in the sitting position to participants. Ischemic compression was performed by compressing trigger points identified by palpation with tolerable intensity using thumb. The duration for each trigger points was 1 minute. Then the muscle containing the trigger point was applied intramuscular stretching for 30 seconds by therapist	Other	ischemic compression group

Primary outcome

Pain intensity
Time frame: Pain intensity was measured using visual analog scale (VAS) before the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Time frame: Depression was assessed using the Beck Depression Inventory (BDI) before the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Neck Pain and Disability Scale
Time frame: Disability was evaluated by Neck Pain and Disability Scale (NPAD) before the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Myofascial trigger points assessment
Time frame: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated before treatment. PPT is a safe outcome measure to evaluate pain sensitivity.
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Myofascial trigger points assessment
Time frame: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated immediately after the treatment.
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Pain intensity
Time frame: Pain intensity was measured using visual analog scale (VAS) at one week after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Time frame: Depression was assessed using the Beck Depression Inventory (BDI) at one week after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Neck Pain and Disability Scale
Time frame: Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one week after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Myofascial trigger points assessment
Time frame: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one week after the treatment.
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena
Pain intensity
Time frame: Pain intensity was measured using visual analog scale (VAS) at one month after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Time frame: Depression was assessed using the Beck Depression Inventory (BDI) at one month after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Neck Pain and Disability Scale
Time frame: Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one month after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.
A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.
Myofascial trigger points assessment
Time frame: The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one month after the treatment.
Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena

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 30 Mar 2021.
Background: PubMed 11871683Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
Background: PubMed 19121461Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature. J Manipulative Physiol Ther. 2009 Jan;32(1):14-24. doi: 10.1016/j.jmpt.2008.06.012.
Background: PubMed 21440713Unalan H, Majlesi J, Aydin FY, Palamar D. Comparison of high-power pain threshold ultrasound therapy with local injection in the treatment of active myofascial trigger points of the upper trapezius muscle. Arch Phys Med Rehabil. 2011 Apr;92(4):657-62. doi: 10.1016/j.apmr.2010.11.030.
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.

Gamze G Pala, PhD principal investigator

Istanbul Aydın University

Ebru Kaya Mutlu, Assoc.Prof. principal investigator

Istanbul University - Cerrahpasa

Hanifegül Taşkıran, Prof. principal investigator

Istanbul Aydın University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 30 Mar 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?

Pain intensity (time frame: Pain intensity was measured using visual analog scale (VAS) before the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)). The study lists 13 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 NCT04823013, which also lists 3 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 30 Mar 2021.