Tension Type HeadacheNCT05673330
Spinal Mobilization Versus Myofacial Release Techniques On Pain And Disability In Patients With Tension Type Headache
A study testing Spinal Mobilizations and Myofascial Release Technique in people with Tension Type Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
The most frequent kind of primary headache is tension headache, often known as stress headache or tension-type headache (TTH). The pain usually affects both sides of the head and might extend from the lower back of the head, the neck, the eyes, or other muscle groups in the body. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Tension Type Headache
- What is being tested?
- Spinal Mobilizations and Myofascial Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Nov 2022to 6 Mar 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Male and female between ages of 30-60 years
- Presence of 2 or more of the following: bilateral headache, pressure or squeezing pain, mild or intermediate pain intensity, and headache not elicited by daily physical activities
- Headache lasting between 30 minutes and 7 days
- Patients with no increase in pain during physical activity
- Patients not having any photophobia, phonophobia during headache
- Headache unaccompanied by vomiting or nausea
Who cannot join
- Any other primary or secondary headache according to the ICHD-III criteria.
- A history of neck or head trauma (e.g., whiplash).
- Any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use).
- Diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis).
- Prior surgery to the cervical spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Spinal Mobilization Versus Myofacial Release Techniques on Pain And Disability In Patients With Tension Type Headache
The most frequent kind of primary headache is tension headache, often known as stress headache or tension-type headache (TTH). The pain usually affects both sides of the head and might extend from the lower back of the head, the neck, the eyes, or other muscle groups in the body. Nearly 90 percent of all headaches are tension-type headaches causing a debilitating effect on job productibility and overall quality of life. The aim of the study will be to compare the effects of spinal mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide with the myofascial release technique on pain and disability in patients with tension-type headache.
Read the detailed description
A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic, NUR International Physical Therapy clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 34 patients which will be allocated using simple random sampling through sealed opaque envelopes into Group A and Group B. Group A will be treated with Spinal Mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide and Group B will be treated with Myofascial release technique. Outcome measures tools will be conducted through NPRS, Headache disability Index, Headache impact test (HIT-6). Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups
- Conditions
- Tension Type Headache
- Being tested
- Spinal Mobilizations, Myofascial Release Technique
- Keywords
- Tension Type Headache
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal MobilizationsOther
Also called Headache SNAG, Maitland's C1-C7 PA Glide
- Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6)
- Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front).
The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks
Myofascial Release TechniqueOther
Also called Suboccipital Inhibition Technique
Suboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved.
The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Mobilizations | Active comparator | 1. Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6)
2. Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front).
The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks. Receives: Other: Spinal Mobilizations |
| Myofascial Release technique | Active comparator | Suboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved.
The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks. Receives: Other: Myofascial Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Classification of Headache Disorders Criteria (ICHD-3 beta)
It is used for diagnosis of the tension type headache and has following specifications: The pain should be bilateral, pressing and tightening pain, having a mild-moderate intensity [≤7.0 on a visual analog scale (VAS)] and there should be no increase in pain with physical activity. The patients should not have phonophobia, nausea, vomiting or photophobia. Headache should last between 30 minutes and 7 days
Measured: 4 weeks
Numeric pain rate scale (NPRS)
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"
Measured: 4 weeks
Headache Disability Index Questionnaire
To quantify the impact of headache on daily living, a 25-item headache disability inventory (HDI) will be used. Each requiring a "yes" (four points), "sometimes" (two points), or "no" (zero points) response based on items derived empirically from case history responses of subjects with headache. Items are sub grouped into functional and emotional subscales
Measured: 4 weeks
Headache Impact Test (HIT-6)
The HIT-6 is a 6-item screening instrument used to quantify headache. It assesses the effects of headaches on daily life activities. This questionnaire has 6 questions, with a maximum number of points of 6*13 (78). A total score of 36 means best and 78 means worst in terms of headache. Scores above 50 are "high".
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start6 Nov 2022
- Primary completion5 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tension Type HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673330
- Sponsor's protocol ID
- REC/RCR&AH/22/Faryall Kemall
- Status last verified
- Apr 2023
- First submitted
- 4 Jan 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corum M, Aydin T, Medin Ceylan C, Kesiktas FN. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101319. doi: 10.1016/j.ctcp.2021.101319. Epub 2021 Jan 24.
PubMed 33517104Zhang Y, Kong Q, Chen J, Li L, Wang D, Zhou J. International Classification of Headache Disorders 3rd edition beta-based field testing of vestibular migraine in China: Demographic, clinical characteristics, audiometric findings and diagnosis statues. Cephalalgia. 2016 Mar;36(3):240-8. doi: 10.1177/0333102415587704. Epub 2015 May 18.
PubMed 25986149Akbas I, Kocak AO, Akgol Gur ST, Oral Ahiskalioglu E, Dogruyol S, Dolanbay T, Demir M, Cakir Z. Lidocaine versus dexketoprofen in treatment of tension-type headache: A double-blind randomized controlled trial. Am J Emerg Med. 2021 Mar;41:125-129. doi: 10.1016/j.ajem.2020.12.057. Epub 2021 Jan 7. No abstract available.
PubMed 33423013GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
PubMed 30353868Schiller J, Karst M, Kellner T, Zheng W, Niederer D, Vogt L, Eckhardt I, Beissner F, Korallus C, Sturm C, Egen C, Gutenbrunner C, Fink MG. Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study. Cephalalgia. 2021 Jul;41(8):879-893. doi: 10.1177/0333102421989620. Epub 2021 Feb 9.
PubMed 33563049Satpute K, Bedekar N, Hall T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2021 Mar 3;22(1):243. doi: 10.1186/s12891-021-04105-y.
PubMed 33657998Pourahmadi M, Dommerholt J, Fernandez-de-Las-Penas C, Koes BW, Mohseni-Bandpei MA, Mansournia MA, Delavari S, Keshtkar A, Bahramian M. Dry Needling for the Treatment of Tension-Type, Cervicogenic, or Migraine Headaches: A Systematic Review and Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab068. doi: 10.1093/ptj/pzab068.
PubMed 33609358Osama M. Effects of autogenic and reciprocal inhibition muscle energy techniques on isometric muscle strength in neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(4):555-564. doi: 10.3233/BMR-200002.
PubMed 33523036Kwon SH, Chung EJ, Lee J, Kim SW, Lee BH. The Effect of Hamstring Relaxation Program on Headache, Pressure Pain Threshold, and Range of Motion in Patients with Tension Headache: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 27;18(19):10137. doi: 10.3390/ijerph181910137.
PubMed 34639438Choi W. Effect of 4 Weeks of Cervical Deep Muscle Flexion Exercise on Headache and Sleep Disorder in Patients with Tension Headache and Forward Head Posture. Int J Environ Res Public Health. 2021 Mar 25;18(7):3410. doi: 10.3390/ijerph18073410.
PubMed 33806089
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spinal Mobilization Versus Myofacial Release Techniques on Pain And Disability In Patients With Tension Type Headache
- ClinicalTrials.gov ID
- NCT05673330
- Acronym / sponsor ID
- REC/RCR&AH/22/Faryall Kemall
- Conditions
- Tension Type Headache
- Keywords
- Tension Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 6 Jan 2023 (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 most frequent kind of primary headache is tension headache, often known as stress headache or tension-type headache (TTH). The pain usually affects both sides of the head and might extend from the lower back of the head, the neck, the eyes, or other muscle groups in the body. Nearly 90 percent of all headaches are tension-type headaches causing a debilitating effect on job productibility and overall quality of life. The aim of the study will be to compare the effects of spinal mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide with the myofascial release technique on pain and disability in patients with tension-type headache.
Detailed description
A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic, NUR International Physical Therapy clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 34 patients which will be allocated using simple random sampling through sealed opaque envelopes into Group A and Group B. Group A will be treated with Spinal Mobilizations comprising Mulligan's headache SNAGs and Maitland's PA glide and Group B will be treated with Myofascial release technique. Outcome measures tools will be conducted through NPRS, Headache disability Index, Headache impact test (HIT-6). Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Mobilizations | Active comparator | Other: Spinal Mobilizations1. Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6) 2. Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front). The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks. |
| Myofascial Release technique | Active comparator | Other: Myofascial Release TechniqueSuboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved. The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Male and female between ages of 30-60 years
Key exclusion criteria (5 listed)
- Any other primary or secondary headache according to the ICHD-III criteria.
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 |
|---|---|---|
| Spinal MobilizationsAlso: Headache SNAG, Maitland's C1-C7 PA Glide1. Headache SNAG: A posteroanterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s with the aim to reduce headache intensity at the time of application. (6) 2. Maitland's C1-C7 PA Glide: A posteroanterior (PA) mobilization of the first till seventh cervical vertebra is achieved by applying a force on to a vertebral segment in a posteroanterior direction (Back to front). The patients will receive Spinal Mobilizations consisting of 1 set of 6 repetitions once daily thrice per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks | Other | Spinal Mobilizations |
| Myofascial Release TechniqueAlso: Suboccipital Inhibition TechniqueSuboccipital Inhibition Technique: While the patient will be in the supine position, the physician sitting at the top end of the table will place the fingers of both hands on the patient's suboccipital region. Flexi-perpendicular long fingers exerting an inhibitory pressure on the muscle insertions of the neck extensors in the occiput, perpendicularly to muscle fibers, while the thumbs counterbalance the head against rotation. A deep and progressive pressure would be applied perpendicular to the fibers until a decrease in muscle tone would be detected. This deep and progressive pressure would be maintained for a total of 10 min until release of suboccipital tissues is achieved. The patients will receive myofascial release with the frequency of 1 set and 10 repetitions once a day three times per week for four weeks. Pre and post intervention values will be taken on 1st day and after 4 weeks. | Other | Myofascial Release technique |
Primary outcome
International Classification of Headache Disorders Criteria (ICHD-3 beta)
Time frame: 4 weeks
It is used for diagnosis of the tension type headache and has following specifications: The pain should be bilateral, pressing and tightening pain, having a mild-moderate intensity [≤7.0 on a visual analog scale (VAS)] and there should be no increase in pain with physical activity. The patients should not have phonophobia, nausea, vomiting or photophobia. Headache should last between 30 minutes and 7 days
Numeric pain rate scale (NPRS)
Time frame: 4 weeks
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"
Headache Disability Index Questionnaire
Time frame: 4 weeks
To quantify the impact of headache on daily living, a 25-item headache disability inventory (HDI) will be used. Each requiring a "yes" (four points), "sometimes" (two points), or "no" (zero points) response based on items derived empirically from case history responses of subjects with headache. Items are sub grouped into functional and emotional subscales
Headache Impact Test (HIT-6)
Time frame: 4 weeks
The HIT-6 is a 6-item screening instrument used to quantify headache. It assesses the effects of headaches on daily life activities. This questionnaire has 6 questions, with a maximum number of points of 6*13 (78). A total score of 36 means best and 78 means worst in terms of headache. Scores above 50 are "high".
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 19 Apr 2023.
- Background: PubMed 33517104Corum M, Aydin T, Medin Ceylan C, Kesiktas FN. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101319. doi: 10.1016/j.ctcp.2021.101319. Epub 2021 Jan 24.
- Background: PubMed 25986149Zhang Y, Kong Q, Chen J, Li L, Wang D, Zhou J. International Classification of Headache Disorders 3rd edition beta-based field testing of vestibular migraine in China: Demographic, clinical characteristics, audiometric findings and diagnosis statues. Cephalalgia. 2016 Mar;36(3):240-8. doi: 10.1177/0333102415587704. Epub 2015 May 18.
- Background: PubMed 33423013Akbas I, Kocak AO, Akgol Gur ST, Oral Ahiskalioglu E, Dogruyol S, Dolanbay T, Demir M, Cakir Z. Lidocaine versus dexketoprofen in treatment of tension-type headache: A double-blind randomized controlled trial. Am J Emerg Med. 2021 Mar;41:125-129. doi: 10.1016/j.ajem.2020.12.057. Epub 2021 Jan 7. No abstract available.
- Background: PubMed 30353868GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
- Background: PubMed 33563049Schiller J, Karst M, Kellner T, Zheng W, Niederer D, Vogt L, Eckhardt I, Beissner F, Korallus C, Sturm C, Egen C, Gutenbrunner C, Fink MG. Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study. Cephalalgia. 2021 Jul;41(8):879-893. doi: 10.1177/0333102421989620. Epub 2021 Feb 9.
- Background: PubMed 33657998Satpute K, Bedekar N, Hall T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2021 Mar 3;22(1):243. doi: 10.1186/s12891-021-04105-y.
- Background: PubMed 33609358Pourahmadi M, Dommerholt J, Fernandez-de-Las-Penas C, Koes BW, Mohseni-Bandpei MA, Mansournia MA, Delavari S, Keshtkar A, Bahramian M. Dry Needling for the Treatment of Tension-Type, Cervicogenic, or Migraine Headaches: A Systematic Review and Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab068. doi: 10.1093/ptj/pzab068.
- Background: PubMed 33523036Osama M. Effects of autogenic and reciprocal inhibition muscle energy techniques on isometric muscle strength in neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(4):555-564. doi: 10.3233/BMR-200002.
- Background: PubMed 34639438Kwon SH, Chung EJ, Lee J, Kim SW, Lee BH. The Effect of Hamstring Relaxation Program on Headache, Pressure Pain Threshold, and Range of Motion in Patients with Tension Headache: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 27;18(19):10137. doi: 10.3390/ijerph181910137.
- Background: PubMed 33806089Choi W. Effect of 4 Weeks of Cervical Deep Muscle Flexion Exercise on Headache and Sleep Disorder in Patients with Tension Headache and Forward Head Posture. Int J Environ Res Public Health. 2021 Mar 25;18(7):3410. doi: 10.3390/ijerph18073410.
- 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.
Muhammad Sanaullah, MS principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mobilizations and Myofascial Release Technique in people with Tension Type Headache, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 5 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 19 Apr 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 Pakistan. 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?
International Classification of Headache Disorders Criteria (ICHD-3 beta) (time frame: 4 weeks). The study lists 4 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 NCT05673330, which also lists 10 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 19 Apr 2023.