Lumbopelvic PainNCT04139603
Effects of Two Different Kinesio Taping Applications on Pain and Functional Mobility in Pregnants With Lumbopelvic Pain
A study testing Lumbopelvic kinesio taping and Abdominal supported lumbopelvic kinesio taping in people with Lumbopelvic Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates and compares the effects of two different kinesio taping applications on pain and functional mobility in pregnancy related lumbopelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lumbopelvic Pain
- What is being tested?
- Lumbopelvic kinesio taping and Abdominal supported lumbopelvic kinesio taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2020to 22 Jun 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being able to read and write in Turkish,
- being in 2nd or 3rd trimester of pregnancy,
- having lumbar or pelvic girdle pain for at least one week
- signing the informed consent form for the study
Who cannot join
- visual, auditory or cognitive problems which may prevent participation to the study
- health problems other than pregnancy related lumbopelvic pain (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities
- Any gynecological or urological problems which may mimic pregnancy related lumbopelvic pain
- Any ddiagnosed pregnancy complications (preeclampsy, pregnancy related hypertension, diabetes, fetal anomaly, etc.)
- Multiple gestation
- History of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology
Show all 11Show fewer
- Positive straight leg raising test result or peripheral sensory or motor impairments which may indicate lumbar interbertebral disc pathology
- History of prepregnancy low back pain
- Using any analgesic or myorelaxant medication
- Contraindications to KT (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
- previous KT experience
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women's and Children's Disease Training and Research Hospital
Istanbul
About this study
Official title: Gebeliğe Bağlı Lumbopelvik Ağrıda İki Farklı Kinezyo Bant Uygulamasının Ağrı ve Fonksiyonel Mobilite Üzerine Etkisi
This study evaluates and compares the effects of two different kinesio taping applications on pain and functional mobility in pregnancy related lumbopelvic pain.
Read the detailed description
Literature studies on the effectiveness of kinesio taping (KT) in pregnancy related lumbopelvic pain (LPP) are limited in number and have methodological shortcomings such as lack of randomization, a control group or assessor and/or patient blindness. Although generally presenting a significant effectiveness of KT on intensity of pain and disability, these parameters are evaluated by subjective methods, and the findings do not rely on quantitative data, in general.
In addition, the intervention parameters used in these studies, such as the KT techniques used, amount of KT tension and duration of the intervention are different from each other, and there is lack of studies comparing the effectiveness of different KT techniques.
In this study, effectiveness of two different KT applications will be compared with placebo KT:
- Lumbopelvic KT (LPKT): Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends.
- Abdominal supported LPKT (ALPKT): An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension.
For placebo application, a Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique.
All participants will undergo a 45-60 minutes of standard ergonomic education after initial assessments and following the first taping applications, They will be observed in regard to their behaviours during different activities such as standing, sitting, walking, turning in bed and standing from the bed. Necessary warnings will be given about correcting their posture and behaviors in terms of ergonomic principles.
- Conditions
- Lumbopelvic Pain
- Being tested
- Lumbopelvic kinesio taping, Abdominal supported lumbopelvic kinesio taping, Placebo tapng
- Keywords
- kinesio tape, pain, functional mobility, ergonomic education, pelvic girdle questionnaire, five times sit to stand test, timed up and go test, stair climb test
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic kinesio tapingOther
Also called Ergonomic education
Kinesio tapes applied to the lumbopelvic region will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.
Abdominal supported lumbopelvic kinesio tapingOther
Also called Ergonomic education
Kinesio tapes applied to the lumbopelvic region and abdominal area will stay 3 days. They will be removed from the sites, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.
Placebo tapngOther
Also called Ergonomic education
Placebo tapes (just like Kinesio tapes) applied to the lumbopelvic region without any tension will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Lumbopelvic kinesio taping (LPKT) | Active comparator | Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends. Receives: Other: Lumbopelvic kinesio taping |
| Abdominal supported lumbopelvic kinesio taping (ALPKT) | Experimental | An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension. Receives: Other: Abdominal supported lumbopelvic kinesio taping |
| Placebo taping | Placebo comparator | A Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique. Receives: Other: Placebo tapng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity during resting
0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in pain intensity during timed up and go (TUG) test
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in pain intensity during five times sit to stand test
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in pain intensity during stair climbing test
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in time of completing timed up and go test (seconds)
All participants will perform the test from a chair (height: 46 cm) with back-support. They will be asked to stand up, walk three meters, turn around, walk back to the chair, and sit down as fast as they can. Time to complete the test will be recorded (sec). Lower times indicate better functional mobility level for walking.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in time of completing five times sit to stand test (seconds)
The participants will sit on a straight back chair (43 cm height) with arms folded across their chest. They will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Time for completing the test will be recorded (sec). Lower times indicate better functional mobility level for sit to stand activity.
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Change in time of completing stair climbing test (seconds)
The participants will be asked to ascend and descend 10 stairs. Time of completing the test will be recorded in seconds. Lower times indicate better functional mobility level in stair activities
Measured: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Secondary outcomes (1)
Change in activity limitation
Turkish version of Pelvic Girdle Questionnaire will be used. Total score of the questionnaire varies between 0 and 75, and higher scores indicate higher activity limitation.
Measured: baseline, three days after the first taping, and one week after the first taping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start27 Jan 2020
- Primary completion1 Feb 2022
- Study completion22 Jun 2022
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 Lumbopelvic PainStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
- Responsible party
- Principal investigator, İlkim Çıtak Karakaya, PT. PhD. Prof., Muğla Sıtkı Koçman University
- Investigators
- İlkim Çıtak Karakaya, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139603
- Sponsor's protocol ID
- 47921137-050.01.04-E.109998
- Status last verified
- Mar 2023
- First submitted
- 22 Oct 2019
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reyhan AC, Dereli EE, Colak TK. Low back pain during pregnancy and Kinesio tape application. J Back Musculoskelet Rehabil. 2017;30(3):609-613. doi: 10.3233/BMR-160584.
PubMed 28035911Kalinowski P, Krawulska A. Kinesio Taping vs. Placebo in Reducing Pregnancy-Related Low Back Pain: A Cross-Over Study. Med Sci Monit. 2017 Dec 26;23:6114-6120. doi: 10.12659/msm.904766.
PubMed 29277836Kuciel N, Sutkowska E, Cienska A, Markowska D, Wrzosek Z. Impact of Kinesio Taping application on pregnant women suffering from pregnancy-related pelvic girdle pain - preliminary study. Ginekol Pol. 2017;88(11):620-625. doi: 10.5603/GP.a2017.0111.
PubMed 29303216
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gebeliğe Bağlı Lumbopelvik Ağrıda İki Farklı Kinezyo Bant Uygulamasının Ağrı ve Fonksiyonel Mobilite Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT04139603
- Acronym / sponsor ID
- 47921137-050.01.04-E.109998
- Conditions
- Lumbopelvic Pain
- Keywords
- kinesio tape, pain, functional mobility, ergonomic education, pelvic girdle questionnaire, five times sit to stand test, timed up and go test, stair climb test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 25 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.
This study evaluates and compares the effects of two different kinesio taping applications on pain and functional mobility in pregnancy related lumbopelvic pain.
Detailed description
Literature studies on the effectiveness of kinesio taping (KT) in pregnancy related lumbopelvic pain (LPP) are limited in number and have methodological shortcomings such as lack of randomization, a control group or assessor and/or patient blindness. Although generally presenting a significant effectiveness of KT on intensity of pain and disability, these parameters are evaluated by subjective methods, and the findings do not rely on quantitative data, in general.
In addition, the intervention parameters used in these studies, such as the KT techniques used, amount of KT tension and duration of the intervention are different from each other, and there is lack of studies comparing the effectiveness of different KT techniques.
In this study, effectiveness of two different KT applications will be compared with placebo KT:
- Lumbopelvic KT (LPKT): Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends.
- Abdominal supported LPKT (ALPKT): An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension.
For placebo application, a Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique.
All participants will undergo a 45-60 minutes of standard ergonomic education after initial assessments and following the first taping applications, They will be observed in regard to their behaviours during different activities such as standing, sitting, walking, turning in bed and standing from the bed. Necessary warnings will be given about correcting their posture and behaviors in terms of ergonomic principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic kinesio taping (LPKT) | Active comparator | Other: Lumbopelvic kinesio tapingTwo I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends. |
| Abdominal supported lumbopelvic kinesio taping (ALPKT) | Experimental | Other: Abdominal supported lumbopelvic kinesio tapingAn abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension. |
| Placebo taping | Placebo comparator | Other: Placebo tapngA Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being able to read and write in Turkish,
- being in 2nd or 3rd trimester of pregnancy,
- having lumbar or pelvic girdle pain for at least one week
- signing the informed consent form for the study
Key exclusion criteria (11 listed)
- visual, auditory or cognitive problems which may prevent participation to the study
- health problems other than pregnancy related lumbopelvic pain (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities
- Any gynecological or urological problems which may mimic pregnancy related lumbopelvic pain
- Any ddiagnosed pregnancy complications (preeclampsy, pregnancy related hypertension, diabetes, fetal anomaly, etc.)
- Multiple gestation
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 |
|---|---|---|
| Lumbopelvic kinesio tapingAlso: Ergonomic educationKinesio tapes applied to the lumbopelvic region will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days. An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided. | Other | Lumbopelvic kinesio taping (LPKT) |
| Abdominal supported lumbopelvic kinesio tapingAlso: Ergonomic educationKinesio tapes applied to the lumbopelvic region and abdominal area will stay 3 days. They will be removed from the sites, and the skin will be checked and cleaned, and then reapplied for the next 3 days. An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided. | Other | Abdominal supported lumbopelvic kinesio taping (ALPKT) |
| Placebo tapngAlso: Ergonomic educationPlacebo tapes (just like Kinesio tapes) applied to the lumbopelvic region without any tension will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days. An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided. | Other | Placebo taping |
Primary outcome
Change in pain intensity during resting
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Change in pain intensity during timed up and go (TUG) test
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Change in pain intensity during five times sit to stand test
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Change in pain intensity during stair climbing test
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.
Change in time of completing timed up and go test (seconds)
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
All participants will perform the test from a chair (height: 46 cm) with back-support. They will be asked to stand up, walk three meters, turn around, walk back to the chair, and sit down as fast as they can. Time to complete the test will be recorded (sec). Lower times indicate better functional mobility level for walking.
Change in time of completing five times sit to stand test (seconds)
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
The participants will sit on a straight back chair (43 cm height) with arms folded across their chest. They will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Time for completing the test will be recorded (sec). Lower times indicate better functional mobility level for sit to stand activity.
Change in time of completing stair climbing test (seconds)
Time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
The participants will be asked to ascend and descend 10 stairs. Time of completing the test will be recorded in seconds. Lower times indicate better functional mobility level in stair activities
1 secondary outcome
Change in activity limitation
Time frame: baseline, three days after the first taping, and one week after the first taping
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 15 Mar 2023.
- Background: PubMed 28035911Reyhan AC, Dereli EE, Colak TK. Low back pain during pregnancy and Kinesio tape application. J Back Musculoskelet Rehabil. 2017;30(3):609-613. doi: 10.3233/BMR-160584.
- Background: PubMed 29277836Kalinowski P, Krawulska A. Kinesio Taping vs. Placebo in Reducing Pregnancy-Related Low Back Pain: A Cross-Over Study. Med Sci Monit. 2017 Dec 26;23:6114-6120. doi: 10.12659/msm.904766.
- Background: PubMed 29303216Kuciel N, Sutkowska E, Cienska A, Markowska D, Wrzosek Z. Impact of Kinesio Taping application on pregnant women suffering from pregnancy-related pelvic girdle pain - preliminary study. Ginekol Pol. 2017;88(11):620-625. doi: 10.5603/GP.a2017.0111.
- 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.
İlkim Çıtak Karakaya principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbopelvic kinesio taping and Abdominal supported lumbopelvic kinesio taping in people with Lumbopelvic Pain, run by Muğla Sıtkı Koçman 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 4 inclusion and 11 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 15 Mar 2023. 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?
Change in pain intensity during resting (time frame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping). The study lists 7 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 NCT04139603, 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 15 Mar 2023.