MigraineNCT04729699
Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
A study testing Aerobic exercise and exercise for TMJ and Aerobic exercise at home in people with Migraine and Temporomandibular Joint Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine. Read more about this study
- Who is it for?
- Ages 37 to 50 years, women only
- Conditions the study is for
- Migraine, Temporomandibular Joint Disorders, Myofascial Trigger Point Pain
- What is being tested?
- Aerobic exercise and exercise for TMJ and Aerobic exercise at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteLithuania
- Study dates
- 13 Jul 2020to 24 Aug 2020
- 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 37 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with migraine 2 or more years ago
- Headache, occurring at least 6 times a year
- Individuals from 18 years of age
- Voluntary patient consent to participate in the study
Who cannot join
- Neurological or psychiatric disorder
- Visiting an orthodontist, taking muscle relaxants
- Head or neck injury, cervical spine hernia, facial or temporomandibular injury
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences, Department of Rehabilitation
Kaunas
About this study
Official title: Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.
Read the detailed description
Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed.
The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).
- Being tested
- Aerobic exercise and exercise for TMJ, Aerobic exercise at home
- Medical subject headings
- Migraine Disorders, Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise and exercise for TMJOther
Aerobic exercise
Aerobic exercise at homeOther
Aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week. Receives: Other: Aerobic exercise and exercise for TMJ |
| Control group | Active comparator | Control group (n=9) was introduced with physiotherapy program in order to perform it independently at home. Receives: Other: Aerobic exercise at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometry for cervical range of motion
Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.
Measured: Baseline to 6 weeks
Algometry for pressure pain thresholds (PPT)
PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²
Measured: Baseline to 6 weeks
Secondary outcomes (2)
Anthropometry for TMJ
TMJ range of motion was measured with a centimeter before and after physiotherapy
Measured: Baseline and after 6 weeks
Functional health and well-being - SF-36v2®
Quality of life was assessed with the SF-36 questionnaire. Measure is divided into 8 subscales: Physical Functioning, Activity Limitation due to Physical Ailments, General Health, Vitality, Social Functioning, Activity Limitation due to Emotional Problems, General Mental Health and Health Transition. Answers were scored (total score 100) and a higher total score meant a better quality of life.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start13 Jul 2020
- Primary completion20 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Smilgiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729699
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
- ClinicalTrials.gov ID
- NCT04729699
- Acronym / sponsor ID
- 001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 28 Jan 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.
The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.
Detailed description
Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed.
The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Aerobic exercise and exercise for TMJIntervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week. |
| Control group | Active comparator | Other: Aerobic exercise at homeControl group (n=9) was introduced with physiotherapy program in order to perform it independently at home. |
Who may qualify
- Ages
- 37 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals diagnosed with migraine 2 or more years ago
- Headache, occurring at least 6 times a year
- Individuals from 18 years of age
- Voluntary patient consent to participate in the study
Key exclusion criteria (3 listed)
- Neurological or psychiatric disorder
- Visiting an orthodontist, taking muscle relaxants
- Head or neck injury, cervical spine hernia, facial or temporomandibular injury
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 |
|---|---|---|
| Aerobic exercise and exercise for TMJAerobic exercise | Other | Intervention group |
| Aerobic exercise at homeAerobic exercise | Other | Control group |
Primary outcome
Goniometry for cervical range of motion
Time frame: Baseline to 6 weeks
Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.
Algometry for pressure pain thresholds (PPT)
Time frame: Baseline to 6 weeks
PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²
2 secondary outcomes
Anthropometry for TMJ
Time frame: Baseline and after 6 weeks
Functional health and well-being - SF-36v2®
Time frame: Baseline and after 6 weeks
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 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and exercise for TMJ and Aerobic exercise at home in people with Migraine and Temporomandibular Joint Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 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 Jan 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 Lithuania. 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?
Goniometry for cervical range of motion (time frame: Baseline to 6 weeks). 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?
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 Jan 2021.