Cervicogenic HeadacheNCT06731114
"Additional Effects of Sternocleidomastoid Release Along With Suboccipital Muscle Release in Management of Cervicogenic Headache'
A study testing Suboccipital muscle release, Conventional physical therapy and Sternocleidomastoid release in people with Cervicogenic Headache, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomised control trial and the purpose of this study is to determine the "Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache". Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Suboccipital muscle release, Conventional physical therapy and Sternocleidomastoid release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be included according to international classification of headache criteria which includes:
- Headache with neck stiffness
- Headache at least once a month in the last 3 months
- Headache with at least 4 score in Numeric Pain Rating Scale(NPRS)
- Unilateral headache with no shift of side
- Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
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- C1-C2 dysfunction
- Headache precipitated by sustained neck movements,myofacial trigger points palpation in neck
- Age group 18-45
- Both male and female
Who cannot join
- Cervical spondylosis
- Headache of non-cervical origin
- Dizziness or visual disturbance
- Cervical radiculopathy/ nerve root involvement/ disc herniation
- Cervical instability/ fracture
- Vertebrobasilar insufficiency
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- Thoracic outlet syndrome
- Cervical spine surgery
- Cervical spondylolisthesis
- Spinal infection or tumors
- Osteoporosis
- meningitis
- subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Furqan Hassan, MS-OMPT,PHD*, 03334056768, furqan.hassan@fui.edu.pk
About this study
This study is a randomised control trial and the purpose of this study is to determine the "Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache".
Read the detailed description
Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction treating. patients with cervicogenic headache are mostly presented with forward head posture and weak deep neck flexors which may excerbate the headache symptoms.Therefore The purpose of this study is to determine the ""Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache
- Conditions
- Cervicogenic Headache
- Being tested
- Suboccipital muscle release, Conventional physical therapy, Sternocleidomastoid release
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital muscle releaseProcedure or surgery
Suboccipital muscle release.6 consecutive sessions for 2 weeks
- Frequency:( 3mins 3 reps) 9 mins .12 sessions in total
Conventional physical therapyProcedure or surgery
TENS and hot pack for 10 mins 6 days a week for consecutive 2 weeks
Sternocleidomastoid releaseProcedure or surgery
Frequency: 5 mins of SCM release and 9 mins (3 mins 3 reps )of suboccipital release. 12 sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | On group A we will perform suboccipital muscle release (3 repititions 3 mins)9 minutes along with conventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks. Receives: Procedure: Suboccipital muscle release; Procedure: Conventional physical therapy |
| Group B | Experimental | On group B we will perform sternocleidomastoid release for 5 mins along with suboccipital muscle release and coventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks . Receives: Procedure: Suboccipital muscle release; Procedure: Conventional physical therapy; Procedure: Sternocleidomastoid release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Measured: 2 weeks
ROM
Cervical rotation will be measured through CROM device
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start15 Jul 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic 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 is a randomized controlled trial having two groups.one group will recieve conventional physical therapy including hot pack and tens for 10mins and suboccipital muscle release ( 3mins 3 reps) 9 mins .12 sessions in total where as group B will receive Sternocleidomastoid release for 5 mins along with suboccipital muscle release and conventional physical therapy.
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT06731114
- Sponsor's protocol ID
- FUI/CTR/2024/58
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Additional Effects of Sternocleidomastoid Release Along With Suboccipital Muscle Release in Management of Cervicogenic Headache'
- ClinicalTrials.gov ID
- NCT06731114
- Acronym / sponsor ID
- FUI/CTR/2024/58
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 12 Dec 2024 (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.
This study is a randomised control trial and the purpose of this study is to determine the "Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache".
Detailed description
Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction treating. patients with cervicogenic headache are mostly presented with forward head posture and weak deep neck flexors which may excerbate the headache symptoms.Therefore The purpose of this study is to determine the ""Additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups.one group will recieve conventional physical therapy including hot pack and tens for 10mins and suboccipital muscle release ( 3mins 3 reps) 9 mins .12 sessions in total where as group B will receive Sternocleidomastoid release for 5 mins along with suboccipital muscle release and conventional physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Suboccipital muscle release, Procedure: Conventional physical therapyOn group A we will perform suboccipital muscle release (3 repititions 3 mins)9 minutes along with conventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks. |
| Group B | Experimental | Procedure: Suboccipital muscle release, Procedure: Conventional physical therapy, Procedure: Sternocleidomastoid releaseOn group B we will perform sternocleidomastoid release for 5 mins along with suboccipital muscle release and coventional physical therapy including TENS and hot pack for 10 mins 6 days a week for consective 2 weeks . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants will be included according to international classification of headache criteria which includes:
- Headache with neck stiffness
- Headache at least once a month in the last 3 months
- Headache with at least 4 score in Numeric Pain Rating Scale(NPRS)
- Unilateral headache with no shift of side
Key exclusion criteria (13 listed)
- Cervical spondylosis
- Headache of non-cervical origin
- Dizziness or visual disturbance
- Cervical radiculopathy/ nerve root involvement/ disc herniation
- Cervical instability/ fracture
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 |
|---|---|---|
| Suboccipital muscle releaseSuboccipital muscle release.6 consecutive sessions for 2 weeks • Frequency:( 3mins 3 reps) 9 mins .12 sessions in total | Procedure or surgery | Group A, Group B |
| Conventional physical therapyTENS and hot pack for 10 mins 6 days a week for consecutive 2 weeks | Procedure or surgery | Group A, Group B |
| Sternocleidomastoid releaseFrequency: 5 mins of SCM release and 9 mins (3 mins 3 reps )of suboccipital release. 12 sessions in total. | Procedure or surgery | Group B |
Primary outcome
Pain Intensity
Time frame: 2 weeks
Pain will be measured on the basis of Numeric Pain Rating Scale score.
ROM
Time frame: 2 weeks
Cervical rotation will be measured through CROM device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital muscle release, Conventional physical therapy and Sternocleidomastoid release in people with Cervicogenic 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Arshad, MS-MSKPT (03315314699, aesharshad4200@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 2 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 12 Dec 2024.