Tension-Type HeadacheNCT04232046
Trigger Point Massage in Chronic Tension Headache
A study testing Massage in people with Tension-Type Headache, run by Mazandaran University of Medical Sciences.
Trial summary
Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 15 Mar 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic tension type headache according to IHS criteria
- Finding painful trigger point in physical examination
- no contraindication for massage
- no prophylactic treatment
- written inform consent
Who cannot join
- Dementia or severe cognitive impairment
- Under Treatment with drugs with prophylactic effect
- History of RA or Cervicocephalic fracture or other skeletal deformity
- Other complementary treatment
About this study
Official title: Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.
They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.
- Conditions
- Tension-Type Headache
- Being tested
- Massage
- Keywords
- Massage, Trigger point
- 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.
MassageOther
Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Trigger point massage Receives: Other: Massage |
| Control | Active comparator | Treatment with standard drug Nortriptyline Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache severity change
By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain
Measured: Mean Visual Analogue Scale sore change in week 4 from the baseline
Secondary outcomes (3)
Headache frequency change
Number of attacks in week
Measured: Change in number of attacks in week 4 from the base line
Headache duration change
Time duration ( in minutes)of attacks in week
Measured: Change in Time duration in week 4 from the baseline
Number of analgesic change
Number of analgesic drugs used during a week
Measured: Change in Number of analgesic drugs used in week 4 from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Feb 2016
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case and control group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Sharifi Razavi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232046
- Sponsor's protocol ID
- 1288
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04232046
- Acronym / sponsor ID
- 1288
- Conditions
- Tension-Type Headache
- Keywords
- Massage, Trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 18 Jan 2020 (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.
Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.
They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MassageTrigger point massage |
| Control | Active comparator | Other: MassageTreatment with standard drug Nortriptyline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic tension type headache according to IHS criteria
- Finding painful trigger point in physical examination
- no contraindication for massage
- no prophylactic treatment
- written inform consent
Key exclusion criteria (4 listed)
- Dementia or severe cognitive impairment
- Under Treatment with drugs with prophylactic effect
- History of RA or Cervicocephalic fracture or other skeletal deformity
- Other complementary treatment
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 |
|---|---|---|
| MassageMassage the trigger points in 8 different points for 1 min in circle direction and 3 times a day. | Other | Control, Intervention |
Primary outcome
Headache severity change
Time frame: Mean Visual Analogue Scale sore change in week 4 from the baseline
By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain
3 secondary outcomes
Headache frequency change
Time frame: Change in number of attacks in week 4 from the base line
Headache duration change
Time frame: Change in Time duration in week 4 from the baseline
Number of analgesic change
Time frame: Change in Number of analgesic drugs used in week 4 from the baseline
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 18 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Tension-Type Headache, run by Mazandaran University of Medical Sciences.
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 5 inclusion and 4 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Headache severity change (time frame: Mean Visual Analogue Scale sore change in week 4 from the baseline). 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 18 Jan 2020.