Tension-Type HeadacheNCT04546165
Manual Therapy in Tension-type Headache
A study testing manipulation plus exercise, suboccipital inhibition plus exercise and exercise in people with Tension-Type Headache, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- manipulation plus exercise, suboccipital inhibition plus exercise and exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2020to 10 Sep 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of TTH was made based on the International Classification of Headache Disorders criteria, third edition (ICHD-3 beta)
- (bilateral localization, pressing and tightening pain, mild-moderate intensity [≤7.0 on a visual analog scale (VAS)]
- no increase in pain during physical activity
- patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ICHD-III diagnostic criteria
- had symptoms for more than 3 months
- the patients had to have had at least one segmental dysfunction of the upper cervical spine in all groups (by functional and pain-provocation tests).
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
- application of other treatment methods such as physical therapy or anesthetic block to the head and neck area within the last 3 months
- initiation of pharmacologic prophylaxis within two months prior to randomization
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Bahcelievler, 34180
About this study
Official title: Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in TTH management
Read the detailed description
Increased cranio-cervical muscle sensitivity is the most prominent finding in TTH. Also, neck pain is markedly more common in individuals with TTH compared with the control population (88.4%, and 56.7%, respectively). Therefore, current research on the pathogenesis of TTH focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. It has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (CNS) due to long-term nociceptive stimuli may play a role in development and chronification of TTH
- Conditions
- Tension-Type Headache
- Being tested
- manipulation plus exercise, suboccipital inhibition plus exercise, exercise
- 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.
manipulation plus exerciseProcedure or surgery
HLVA manipulation was performed for 8 sessions (twice a week for four weeks) using a segment-specific technique for segmental dysfunctions of the upper cervical spine. . By bringing the cervical spine to light flexion and about 15-20º lateral flexion without any rotational motion, the middle finger of the manipulating hand provided deep contact, and an HVLA thrust was applied out of the rotational slack by applying a deep force from the dorsal to the ventral direction
suboccipital inhibition plus exerciseProcedure or surgery
Suboccipital inhibition was performed for 8 sessions (twice a week for four weeks) as a combined muscle and soft tissue inhibition technique. While the patient was in the supine position, the physician sitting at the top end of the table placed the fingers of both hands on the patient's suboccipital region
exerciseProcedure or surgery
Patients were asked to exercise at least three days a week during treatment. The exercise program, which lasted 20 to 30 minutes, included cervical range of motion (ROM) exercises to warm-up and cool-down, and then stretching exercises of cervical and upper thoracic spine muscles (trapezius, levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric contraction and concentric contraction of the deep cervical flexor muscles).
| Study group | Role | What they receive |
|---|---|---|
| manipulation group | Active comparator | manipulation plus exercise Receives: Procedure: suboccipital inhibition plus exercise; Procedure: exercise |
| myofascial release group | Active comparator | suboccipital inhibition plus exercise Receives: Procedure: manipulation plus exercise; Procedure: exercise |
| exercise group | Active comparator | only exercise Receives: Procedure: manipulation plus exercise; Procedure: suboccipital inhibition plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency (HF)
. Headache frequency was measured as the total number of days with headache (days/2-week) in the previous 2 weeks.
Measured: Changes from baseline in Headache Frequency Score to 1 month and 3 months
Secondary outcomes (4)
Visual Analog Scale (VAS)
The self-evaluation of pain severity of headache and neck pain during rest and activity in the previous week was calculated using a 10-cm VAS scale, where 0 in the left corner of the scale represented 'no pain' and 10 in the right corner represented 'the worst pain that could be imagined'
Measured: Changes from baseline in Visual Analog Scale Score to 1 month and 3 months
Headache Impact Test-6 (HIT-6)
The total score was calculated in HIT-6, which consisted of 6 questions with 5 answer options for each (never: 6 points, rarely: 8 points, sometimes: 10 points, very often: 11 points, always: 13 points). A total score of 36 means best and 78 means worst in terms of headache
Measured: Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months
Neck Disability Index (NDI)
The NDI consists of 10 questions about pain disability in the neck region ("no disability" = 0, and "full disability" = 5). The total NDI score was calculated, with 0 showing the best score and 50 showing the worst score.
Measured: Changes from baseline in Neck Disability Index Score to 1 month and 3 months
Pressure-Pain Threshold (PTT)
PPT measurements were performed using a mechanical pressure algometer on the temporalis anterior muscle The feeling of pressure was gradually increased until it turned into pain or discomfort, at which point the pressure value was recorded.
Measured: Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start22 Jun 2020
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Corum, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Mustafa Corum, MD, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546165
- Sponsor's protocol ID
- 2020/289
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04546165
- Acronym / sponsor ID
- 2020/289
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 11 Sep 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.
Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in TTH management
Detailed description
Increased cranio-cervical muscle sensitivity is the most prominent finding in TTH. Also, neck pain is markedly more common in individuals with TTH compared with the control population (88.4%, and 56.7%, respectively). Therefore, current research on the pathogenesis of TTH focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. It has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (CNS) due to long-term nociceptive stimuli may play a role in development and chronification of TTH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| manipulation group | Active comparator | Procedure: suboccipital inhibition plus exercise, Procedure: exercisemanipulation plus exercise |
| myofascial release group | Active comparator | Procedure: manipulation plus exercise, Procedure: exercisesuboccipital inhibition plus exercise |
| exercise group | Active comparator | Procedure: manipulation plus exercise, Procedure: suboccipital inhibition plus exerciseonly exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosis of TTH was made based on the International Classification of Headache Disorders criteria, third edition (ICHD-3 beta)
- (bilateral localization, pressing and tightening pain, mild-moderate intensity [≤7.0 on a visual analog scale (VAS)]
- no increase in pain during physical activity
- patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ICHD-III diagnostic criteria
- had symptoms for more than 3 months
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| manipulation plus exerciseHLVA manipulation was performed for 8 sessions (twice a week for four weeks) using a segment-specific technique for segmental dysfunctions of the upper cervical spine. . By bringing the cervical spine to light flexion and about 15-20º lateral flexion without any rotational motion, the middle finger of the manipulating hand provided deep contact, and an HVLA thrust was applied out of the rotational slack by applying a deep force from the dorsal to the ventral direction | Procedure or surgery | exercise group, myofascial release group |
| suboccipital inhibition plus exerciseSuboccipital inhibition was performed for 8 sessions (twice a week for four weeks) as a combined muscle and soft tissue inhibition technique. While the patient was in the supine position, the physician sitting at the top end of the table placed the fingers of both hands on the patient's suboccipital region | Procedure or surgery | exercise group, manipulation group |
| exercisePatients were asked to exercise at least three days a week during treatment. The exercise program, which lasted 20 to 30 minutes, included cervical range of motion (ROM) exercises to warm-up and cool-down, and then stretching exercises of cervical and upper thoracic spine muscles (trapezius, levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric contraction and concentric contraction of the deep cervical flexor muscles). | Procedure or surgery | manipulation group, myofascial release group |
Primary outcome
Headache Frequency (HF)
Time frame: Changes from baseline in Headache Frequency Score to 1 month and 3 months
. Headache frequency was measured as the total number of days with headache (days/2-week) in the previous 2 weeks.
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Changes from baseline in Visual Analog Scale Score to 1 month and 3 months
Headache Impact Test-6 (HIT-6)
Time frame: Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months
Neck Disability Index (NDI)
Time frame: Changes from baseline in Neck Disability Index Score to 1 month and 3 months
Pressure-Pain Threshold (PTT)
Time frame: Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months
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 20 Nov 2020.
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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.
Mustafa Corum, MD study chair
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation plus exercise, suboccipital inhibition plus exercise and exercise in people with Tension-Type Headache, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 6 inclusion and 8 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 20 Nov 2020. 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?
Headache Frequency (HF) (time frame: Changes from baseline in Headache Frequency Score to 1 month and 3 months). 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 20 Nov 2020.