Cervicogenic HeadacheNCT06534606
Additional Effects of Sternocleidomastoid Release With SNAGS in the Management of Cervicogenic Headache
A study testing Electrotherapy and physical agents, Headache SNAGs and Sternocleidomastoid Release in people with Cervicogenic Headache, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Electrotherapy and physical agents, Headache SNAGs and Sternocleidomastoid Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 30 Dec 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group: 18-45 years old
- Both males and females
- Unilateral headache with no shift of side
- C1-C2 Dysfunction
- Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
- Headache at least once a month in the last 3 months
Show all 13Show fewer
- Headache with at least 4 score in NPRS (Sign and Symptoms of Neck Involvement)
- Headache with restriction of ROM in the neck
- Headache precipitated by:
- Sustained neck movements, and awkward head positioning. External Pressure over upper cervical or occipital region
- Headache Characteristics:
- Moderate-severe, non-throbbing pain, usually starting in the neck.
- Episodes of varying duration, or: fluctuating, continuous pain
Who cannot join
- Headache of non-cervical origin
- Diagnosed Cases of:Cervical spondylosis,Cervical radiculopathy/ nerve root involvement/ disc herniation,Cervical instability/ fracture,Vertebrobasilar insufficiency ,Cervical spine surgery,Cervical spondylolisthesis,Spinal infection or tumors,Osteoporosis,History of trauma,Rheumatoid Arthritis,Inflammatory Arthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. SNAGs are highly effective in the treatment approach for these patients. Sternocleidomastoid muscle receive overactive tension from forward neck posture, increasing muscular fatigue and tone of muscles. This tension in SCM causes referred pain in the head and neck region. SNAGs are very effective but musculoskeletal impairments especially the tightness of sternocleidomastoid muscle still persist and can exacerbate symptoms. Manual therapy targeted to the SCM muscle may be effective for reducing headache and neck pain intensity and increasing performance of deep cervical flexors. Findings of this study will aid the therapists in choosing which technique to use while treating the patients. This will save therapist's time and effort as they will not be using the less effective treatment protocol. Furthermore, patient's time and investment will be used in the right direction.
- Conditions
- Cervicogenic Headache
- Being tested
- Electrotherapy and physical agents, Headache SNAGs, 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.
Electrotherapy and physical agentsProcedure or surgery
Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
- TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
Headache SNAGsProcedure or surgery
Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold.
- Frequency: 3 times a week for 2 weeks. 6 sessions in total.
Sternocleidomastoid ReleaseProcedure or surgery
Sternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes.Frequency: 3 times a week for 2 weeks. 6 sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy Group | Active comparator | Both Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache.
* Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
* TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
In addition to this, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold.
• Frequency: 3 times a week for 2 weeks. 6 sessions in total. Receives: Procedure: Electrotherapy and physical agents; Procedure: Headache SNAGs |
| Conventional physical therapy with sternocleidomastoid release | Experimental | Both Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache.
* Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
* TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks.
Headache SNAGs: In addition to the conventional physical therapy protocol, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold.
* Frequency: 3 times a week for 2 weeks. 6 sessions in total. Sternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes.
* Frequency: 3 times a week for 2 weeks. 6 sessions in total. Receives: Procedure: Electrotherapy and physical agents; Procedure: Headache SNAGs; 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
Range of motion
Cervical rotation will be measured through CROM device
Measured: 2 weeks
Headache Disability
Headache Disability Index will be used
Measured: 2 weeks
Cervical Proprioception
Joint Position Error Test will be used
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 posted2 Aug 2024
- Study start10 Jun 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT06534606
- Sponsor's protocol ID
- FUI/CTR/2024/17
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Sternocleidomastoid Release With SNAGS in the Management of Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT06534606
- Acronym / sponsor ID
- FUI/CTR/2024/17
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Aug 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.
Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. SNAGs are highly effective in the treatment approach for these patients. Sternocleidomastoid muscle receive overactive tension from forward neck posture, increasing muscular fatigue and tone of muscles. This tension in SCM causes referred pain in the head and neck region. SNAGs are very effective but musculoskeletal impairments especially the tightness of sternocleidomastoid muscle still persist and can exacerbate symptoms. Manual therapy targeted to the SCM muscle may be effective for reducing headache and neck pain intensity and increasing performance of deep cervical flexors. Findings of this study will aid the therapists in choosing which technique to use while treating the patients. This will save therapist's time and effort as they will not be using the less effective treatment protocol. Furthermore, patient's time and investment will be used in the right direction.
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 receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy Group | Active comparator | Procedure: Electrotherapy and physical agents, Procedure: Headache SNAGsBoth Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache. * Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. * TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. In addition to this, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. • Frequency: 3 times a week for 2 weeks. 6 sessions in total. |
| Conventional physical therapy with sternocleidomastoid release | Experimental | Procedure: Electrotherapy and physical agents, Procedure: Headache SNAGs, Procedure: Sternocleidomastoid ReleaseBoth Group A and Group B will receive this conventional physical therapy protocol for cervicogenic headache. * Moist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. * TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. Headache SNAGs: In addition to the conventional physical therapy protocol, they will receive Headache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. Sternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes. * Frequency: 3 times a week for 2 weeks. 6 sessions in total. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age group: 18-45 years old
- Both males and females
- Unilateral headache with no shift of side
- C1-C2 Dysfunction
- Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
Key exclusion criteria (2 listed)
- Headache of non-cervical origin
- Diagnosed Cases of:Cervical spondylosis,Cervical radiculopathy/ nerve root involvement/ disc herniation,Cervical instability/ fracture,Vertebrobasilar insufficiency ,Cervical spine surgery,Cervical spondylolisthesis,Spinal infection or tumors,Osteoporosis,History of trauma,Rheumatoid Arthritis,Inflammatory Arthritis
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 |
|---|---|---|
| Electrotherapy and physical agentsMoist heat therapy: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. • TENS application: Frequency: 15 minutes, 3 times per week (alternatively) for 2 weeks. | Procedure or surgery | Conventional physical therapy Group, Conventional physical therapy with sternocleidomastoid release |
| Headache SNAGsHeadache SNAGs (Sustained Natural Apophyseal Glides) 5 sets of 10 repetitions. Each repetition will be given with a 10 second hold. • Frequency: 3 times a week for 2 weeks. 6 sessions in total. | Procedure or surgery | Conventional physical therapy Group, Conventional physical therapy with sternocleidomastoid release |
| Sternocleidomastoid ReleaseSternocleidomastoid Release: Group B will also receive Sternocleidomastoid release in addition with headache SNAGs. Release to the sternocleidomastoid muscle will be given once per session for 5-8 minutes.Frequency: 3 times a week for 2 weeks. 6 sessions in total. | Procedure or surgery | Conventional physical therapy with sternocleidomastoid release |
Primary outcome
Pain intensity
Time frame: 2 weeks
Pain will be measured on the basis of Numeric Pain Rating Scale score.
Range of motion
Time frame: 2 weeks
Cervical rotation will be measured through CROM device
Headache Disability
Time frame: 2 weeks
Headache Disability Index will be used
Cervical Proprioception
Time frame: 2 weeks
Joint Position Error Test will be used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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. 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 Electrotherapy and physical agents, Headache SNAGs 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 13 inclusion and 2 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 2 Aug 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?
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?
Pain intensity (time frame: 2 weeks). The study lists 4 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 2 Aug 2024.