Tension-Type HeadacheNCT05883813
Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
A study testing sustained natural apophyseal glides (SNAGS), suboccipital muscle release and Supplemental therapy in people with Tension-Type Headache, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- sustained natural apophyseal glides (SNAGS), suboccipital muscle release and Supplemental therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Jul 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years old
- Male and Female
- International classification of headache disorders-3 diagnosis:
- Headache occurring on 15 days/month on average for >3 months (180 days/year),
- Lasting hours to days, or unremitting -At least two of the following four characteristics:-
- Bilateral location
Show all 13Show fewer
- Pressing or tightening (non-pulsating) quality
- Mild or moderate intensity
- Not aggravated by routine physical activity such as walking or climbing stairs
- Both of the following:
- No more than one of photophobia, phonophobia or mild nausea
- Neither moderate or severe nausea nor vomiting
- Not better accounted for by another ICHD-3 diagnosis.
Who cannot join
- Patients with other types of primary or secondary headache e.g cervicogenic headache
- History of trauma to the cervical spine
- Vertigo, dizziness, uncompensated neck tension
- Spurling test positive
- Flexion compression test positive
- Extension compression test positive
- Cervical flexion rotation test positive
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.
Read the detailed description
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is one of the widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished.Chronic tension type headache causes tightness in the suboccipital muscle which may result in decrese in range of motion in cervical region. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.
This study will be conducted in fauji foundation hospital using non-probability purposive sampling technique. Sample size calaculated from open epi tool is 48, with 24 patients in each group. Patients are selected on the basis of inclusion criteria. Patients will be guided about the benefits and risks of the study, right to withdraw from the study at any point and confidentiality of the data. After diagnosis by the physician according to the ICHD-3 criteria, written consent will be taken from each participant. Then they randomly assigned into 2 groups via lottery method. Cervical range of motion, blood pressure and pain intensity will be measured before and after the treatment. Suboccipital muscle release and SNAGS will be given to experimental group and suboccipital muscle release only to the control group.
Group 1(Control group): suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps.
Group 2(Experimental group): suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps.
Sub-occipital muscle release: This technique will be performed in the supine position with the patient's eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.
SNAGS: This technique will be performed with patient in sitting position and the therapist may be standing behind the patient. The therapist would place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide were given and maintain for 10 seconds at end range.
Pain intensity, cervical range of motion and blood pressure will be measured immediately after the treatment.
- Conditions
- Tension-Type Headache
- Being tested
- sustained natural apophyseal glides (SNAGS), suboccipital muscle release, Supplemental therapy
- 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.
sustained natural apophyseal glides (SNAGS)Procedure or surgery
SNAGS will be given with patient in sitting position and the therapist will be standing behind the patient. The therapist will place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide will be given and each glide will be maintained for 10 seconds at end range.
suboccipital muscle releaseProcedure or surgery
Sub-occipital muscle release will be applied with the patient in the supine position with the eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.
Supplemental therapyProcedure or surgery
General warm-up exercises, TENS, hot pack, trapezius stretching
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps Receives: Procedure: suboccipital muscle release; Procedure: Supplemental therapy |
| Group 2 | Experimental | suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps Receives: Procedure: sustained natural apophyseal glides (SNAGS); Procedure: suboccipital muscle release; Procedure: Supplemental therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical range of motion
The cervical range of motion will be measured by using goniometer. The patient will be in sitting position. For flexion and extension, the fulcrum will be placed on external auditory meatus, the stationary arm will be vertical to the ground with moving arm aligned parallel with the base of the ear. For side bending, the fulcrum will be placed on C7 vertebrae, the stationary arm perpendicular to the ground and moving arm parallel to the external occipital protuberence. For rotation, the fulcrum will be placed on the central cranial aspect of head, stationary arm parallel to the acromion process and moving arm align with tip of the nose. The angle between the stationary and moving arm will be measured.
Measured: Immediate after treatment
Secondary outcomes (2)
Pain intensity
Will be measured with NPRS
Measured: Immediate after treatment
Blood pressure
Will be measured with sphygmomanometer
Measured: Immediate after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
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.
- More trials run by Foundation University IslamabadThe 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
- Model description
- This study is randomized controlled trial which consist of 2 groups. One group will be given suboccipital muscle release. Second group will be given SNAGS along with sub-occipital muscle release. All the groups were recruited concurrently.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883813
- Sponsor's protocol ID
- FUI/CTR/2023/11
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
- ClinicalTrials.gov ID
- NCT05883813
- Acronym / sponsor ID
- FUI/CTR/2023/11
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 1 Jun 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.
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.
Detailed description
Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is one of the widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished.Chronic tension type headache causes tightness in the suboccipital muscle which may result in decrese in range of motion in cervical region. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.
This study will be conducted in fauji foundation hospital using non-probability purposive sampling technique. Sample size calaculated from open epi tool is 48, with 24 patients in each group. Patients are selected on the basis of inclusion criteria. Patients will be guided about the benefits and risks of the study, right to withdraw from the study at any point and confidentiality of the data. After diagnosis by the physician according to the ICHD-3 criteria, written consent will be taken from each participant. Then they randomly assigned into 2 groups via lottery method. Cervical range of motion, blood pressure and pain intensity will be measured before and after the treatment. Suboccipital muscle release and SNAGS will be given to experimental group and suboccipital muscle release only to the control group.
Group 1(Control group): suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps.
Group 2(Experimental group): suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps.
Sub-occipital muscle release: This technique will be performed in the supine position with the patient's eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.
SNAGS: This technique will be performed with patient in sitting position and the therapist may be standing behind the patient. The therapist would place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide were given and maintain for 10 seconds at end range.
Pain intensity, cervical range of motion and blood pressure will be measured immediately after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is randomized controlled trial which consist of 2 groups. One group will be given suboccipital muscle release. Second group will be given SNAGS along with sub-occipital muscle release. All the groups were recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: suboccipital muscle release, Procedure: Supplemental therapysuboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps |
| Group 2 | Experimental | Procedure: sustained natural apophyseal glides (SNAGS), Procedure: suboccipital muscle release, Procedure: Supplemental therapysuboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18-64 years old
- Male and Female
- International classification of headache disorders-3 diagnosis:
- Headache occurring on 15 days/month on average for >3 months (180 days/year),
- Lasting hours to days, or unremitting -At least two of the following four characteristics:-
Key exclusion criteria (8 listed)
- Patients with other types of primary or secondary headache e.g cervicogenic headache
- History of trauma to the cervical spine
- Vertigo, dizziness, uncompensated neck tension
- Spurling test positive
- Flexion compression test positive
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 |
|---|---|---|
| sustained natural apophyseal glides (SNAGS)SNAGS will be given with patient in sitting position and the therapist will be standing behind the patient. The therapist will place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide will be given and each glide will be maintained for 10 seconds at end range. | Procedure or surgery | Group 2 |
| suboccipital muscle releaseSub-occipital muscle release will be applied with the patient in the supine position with the eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment. | Procedure or surgery | Group 1, Group 2 |
| Supplemental therapyGeneral warm-up exercises, TENS, hot pack, trapezius stretching | Procedure or surgery | Group 1, Group 2 |
Primary outcome
cervical range of motion
Time frame: Immediate after treatment
The cervical range of motion will be measured by using goniometer. The patient will be in sitting position. For flexion and extension, the fulcrum will be placed on external auditory meatus, the stationary arm will be vertical to the ground with moving arm aligned parallel with the base of the ear. For side bending, the fulcrum will be placed on C7 vertebrae, the stationary arm perpendicular to the ground and moving arm parallel to the external occipital protuberence. For rotation, the fulcrum will be placed on the central cranial aspect of head, stationary arm parallel to the acromion process and moving arm align with tip of the nose. The angle between the stationary and moving arm will be measured.
2 secondary outcomes
Pain intensity
Time frame: Immediate after treatment
Blood pressure
Time frame: Immediate after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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 sustained natural apophyseal glides (SNAGS), suboccipital muscle release and Supplemental therapy in people with Tension-Type Headache, run by Foundation University Islamabad 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 13 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: status not confirmed, as of the sponsor's last update on 1 Jun 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?
Results are not available in the source record.
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?
cervical range of motion (time frame: Immediate after treatment). 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 1 Jun 2023.