Cervicogenic HeadacheNCT04993950
Effects of SNAGS Along With Thoracic Postural Correction Techniques in Patients With Chronic Cervicogenic Headache
A study testing sustained natural apophyseal glides and SNAGS with thoracic postural correction techniques in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find out the effects of Mulligan SNAGs along with thoracic postural correction techniques on patients with chronic cervicogenic headache. Patients suffering from cervicogenic headache are often associated with muscle imbalance. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- sustained natural apophyseal glides and SNAGS with thoracic postural correction techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2022to 20 Aug 2022
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients having headache for the last three months
- Patients having unilateral neck pain along with stiffness.
- A headache that is more frequent periorbitally, spreading to the temporal and ocular region and in the low occipital and less frequent in the frontal, parietal and facial region.
- Pain that is usually elicited by applying external pressure on at least 1 of the upper cervical joints (C0-C3) and moderate to severe non throbbing pain
Who cannot join
- Other types of headaches
- Congenital conditions of the cervical spine
- Disc herniation
- Cervical Fractures
- Degenerating disease of the cervical spine.
- Patients with contraindications to mobilization techniques and those with dizziness due to vertebrobasilar insufficiency or vestibular dysfunctions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sustained Natural Apophyseal Glides Along With Thoracic Postural Correction Techniques in Patients With Chronic Cervicogenic Headache
The aim of this study is to find out the effects of Mulligan SNAGs along with thoracic postural correction techniques on patients with chronic cervicogenic headache. Patients suffering from cervicogenic headache are often associated with muscle imbalance. This study will be significant in determining the effects of SNAGs along with thoracic postural correction techniques to improve pain, level of disability and functional status in patients of cervicogenic headache.
It will be Randomized controlled trial study design Data will be collected from Lady reading Hospital Peshawar Purposive sampling, group randomization using lottery method will be used in this study.
Read the detailed description
Headaches are a common condition affecting 47% of the global population,1,2 with cervicogenic headaches (CGHs) accounting for 15-20% of all chronic and recurrent headaches. The International Headache Society has classified a cervicogenic headaches as a secondary headache with 'pain referred from a source in the neck and perceived in one or more regions of the head and/or face. In the case of cervicogenic headache, the cause is a disorder of the cervical spine and its component bone, disc and/or soft tissue elements. The term cervicogenic headache is commonly misused and does not simply apply to a headache associated with neck pain; many headache disorders, including migraine and tension-type headache, can have associated neck pain/tension. Rather, there must be evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause a headache (1). It is often worsened by neck movement, sustained awkward head position or external pressure over the upper cervical or occipital region the symptomatic side (2). The prevalence of Chronic headache has been reported to be between 0.4 and 20 % of the headache population (3). In recent years, there has been an increasing knowledge in the pathogenesis and better management of chronic headaches.
Current scientific evidence supports the role of manual therapies in the management of tension type and cervicogenic headache (4). Individuals with Chronic headache are frequently treated with spinal manipulative therapy including both mobilization and manipulation. Spinal mobilization consists of slow, rhythmical, oscillating techniques (5) Cervical sustained natural apophyseal glides (SNAGs) are 'mobilization with movement' technique in which a sustained accessory facet glide is applied together with active physiological movement. The therapist may apply the glide over the spinous process (central SNAGs) or over the articular pillar on one side (unilateral SNAGs). SNAGs have been advocated for the treatment of neck pain and range of movement (ROM) restriction. SNAGs have been shown to be effective for the treatment of neck pain, cervicogenic headaches, and cervicogenic dizziness (6).mobilization with movement utilize the dual role of bot therapist force (accessory glides) and patient effort (active physiological or functional movement) and techniques are often carried out in a variety of weight bearing positions, with treatment belts, and either additional therapist, assistant or patient applied overpressure A thorough clinical examination is performed and appropriate level is identified, the glide is then performed parallel to the perceived facet plane and the degree of glide is determined by patient's active movement response (8). Many studies on the short-term effectiveness and manual therapy to the cervical spine (mobilization and manipulative therapy) have found it beneficial in reducing headache pain or disability, intensity, frequency, and duration.
- Conditions
- Cervicogenic Headache
- Being tested
- sustained natural apophyseal glides, SNAGS with thoracic postural correction techniques
- Keywords
- cervicogenic headache, thoracic posture correction, SNAGS
- 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.
sustained natural apophyseal glidesOther
SNAGS will be applied in flexion, extension and rotation for a few seconds with 3 repetitions on the first day and 10 repetitions from the next visit.
SNAGS with thoracic postural correction techniquesOther
thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15-20 seconds with 10 repetitions of each stretch per session
| Study group | Role | What they receive |
|---|---|---|
| sustained natural apophyseal glides | Experimental | SNAGS will be applied in flexion, extension and rotation for a few seconds with 3 repetitions on the first day and 10 repetitions from the next visit. Receives: Other: sustained natural apophyseal glides; Other: SNAGS with thoracic postural correction techniques |
| SNAGS with thoracic postural correction techniques | Active comparator | active as well as therapist-facilitated stretches.thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15-20 seconds with 10 repetitions of each stretch per session Receives: Other: sustained natural apophyseal glides; Other: SNAGS with thoracic postural correction techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale (VAS)
The VAS is a 10- cm graduated line. Each participant will self-assess the intensity of her pain. Patients in each group will be instructed to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far-left end indicates "no pain" and the far right end indicates worst pain ever
Measured: four weeks
Neck Disability Index (NDI)
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain.
Measured: for four weeks
Headache Impact Test
Headache Impact Test is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function.
Measured: for four weeks
Cervical ROM --Universal Goniometer
A large universal goniometer having a stationary arm and a moving arm of 12 inch and full circle body will be used for measuring cervical range of motion.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Feb 2022
- Primary completion1 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993950
- Sponsor's protocol ID
- REC/01008 Urooj Sajjad
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.
PubMed 24421621Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
PubMed 22460941Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
PubMed 26852024Fernandez-de-Las-Penas C, Courtney CA. Clinical reasoning for manual therapy management of tension type and cervicogenic headache. J Man Manip Ther. 2014 Feb;22(1):44-50. doi: 10.1179/2042618613Y.0000000050.
PubMed 24976747McDowell JM, Johnson GM, Hetherington BH. Mulligan Concept manual therapy: standardizing annotation. Man Ther. 2014 Oct;19(5):499-503. doi: 10.1016/j.math.2013.12.006. Epub 2014 Jan 10.
PubMed 24491791McDonnell MK, Sahrmann SA, Van Dillen L. A specific exercise program and modification of postural alignment for treatment of cervicogenic headache: a case report. J Orthop Sports Phys Ther. 2005 Jan;35(1):3-15. doi: 10.2519/jospt.2005.35.1.3.
PubMed 15754599Tul Ain SQ, Shakil Ur Rehman S, Maryam M, Kiani SK. Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial. J Pak Med Assoc. 2019 Nov;69(11):1584-1587. doi: 10.5455/JPMA.274875..
PubMed 31740859Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
PubMed 24792139Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
PubMed 18803999
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained Natural Apophyseal Glides Along With Thoracic Postural Correction Techniques in Patients With Chronic Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT04993950
- Acronym / sponsor ID
- REC/01008 Urooj Sajjad
- Conditions
- Cervicogenic Headache
- Keywords
- cervicogenic headache, thoracic posture correction, SNAGS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 6 Aug 2021 (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.
The aim of this study is to find out the effects of Mulligan SNAGs along with thoracic postural correction techniques on patients with chronic cervicogenic headache. Patients suffering from cervicogenic headache are often associated with muscle imbalance. This study will be significant in determining the effects of SNAGs along with thoracic postural correction techniques to improve pain, level of disability and functional status in patients of cervicogenic headache.
It will be Randomized controlled trial study design Data will be collected from Lady reading Hospital Peshawar Purposive sampling, group randomization using lottery method will be used in this study.
Detailed description
Headaches are a common condition affecting 47% of the global population,1,2 with cervicogenic headaches (CGHs) accounting for 15-20% of all chronic and recurrent headaches. The International Headache Society has classified a cervicogenic headaches as a secondary headache with 'pain referred from a source in the neck and perceived in one or more regions of the head and/or face. In the case of cervicogenic headache, the cause is a disorder of the cervical spine and its component bone, disc and/or soft tissue elements. The term cervicogenic headache is commonly misused and does not simply apply to a headache associated with neck pain; many headache disorders, including migraine and tension-type headache, can have associated neck pain/tension. Rather, there must be evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause a headache (1). It is often worsened by neck movement, sustained awkward head position or external pressure over the upper cervical or occipital region the symptomatic side (2). The prevalence of Chronic headache has been reported to be between 0.4 and 20 % of the headache population (3). In recent years, there has been an increasing knowledge in the pathogenesis and better management of chronic headaches.
Current scientific evidence supports the role of manual therapies in the management of tension type and cervicogenic headache (4). Individuals with Chronic headache are frequently treated with spinal manipulative therapy including both mobilization and manipulation. Spinal mobilization consists of slow, rhythmical, oscillating techniques (5) Cervical sustained natural apophyseal glides (SNAGs) are 'mobilization with movement' technique in which a sustained accessory facet glide is applied together with active physiological movement. The therapist may apply the glide over the spinous process (central SNAGs) or over the articular pillar on one side (unilateral SNAGs). SNAGs have been advocated for the treatment of neck pain and range of movement (ROM) restriction. SNAGs have been shown to be effective for the treatment of neck pain, cervicogenic headaches, and cervicogenic dizziness (6).mobilization with movement utilize the dual role of bot therapist force (accessory glides) and patient effort (active physiological or functional movement) and techniques are often carried out in a variety of weight bearing positions, with treatment belts, and either additional therapist, assistant or patient applied overpressure A thorough clinical examination is performed and appropriate level is identified, the glide is then performed parallel to the perceived facet plane and the degree of glide is determined by patient's active movement response (8). Many studies on the short-term effectiveness and manual therapy to the cervical spine (mobilization and manipulative therapy) have found it beneficial in reducing headache pain or disability, intensity, frequency, and duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sustained natural apophyseal glides | Experimental | Other: sustained natural apophyseal glides, Other: SNAGS with thoracic postural correction techniquesSNAGS will be applied in flexion, extension and rotation for a few seconds with 3 repetitions on the first day and 10 repetitions from the next visit. |
| SNAGS with thoracic postural correction techniques | Active comparator | Other: sustained natural apophyseal glides, Other: SNAGS with thoracic postural correction techniquesactive as well as therapist-facilitated stretches.thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15-20 seconds with 10 repetitions of each stretch per session |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having headache for the last three months
- Patients having unilateral neck pain along with stiffness.
- A headache that is more frequent periorbitally, spreading to the temporal and ocular region and in the low occipital and less frequent in the frontal, parietal and facial region.
- Pain that is usually elicited by applying external pressure on at least 1 of the upper cervical joints (C0-C3) and moderate to severe non throbbing pain
Key exclusion criteria (6 listed)
- Other types of headaches
- Congenital conditions of the cervical spine
- Disc herniation
- Cervical Fractures
- Degenerating disease of 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 |
|---|---|---|
| sustained natural apophyseal glidesSNAGS will be applied in flexion, extension and rotation for a few seconds with 3 repetitions on the first day and 10 repetitions from the next visit. | Other | SNAGS with thoracic postural correction techniques, sustained natural apophyseal glides |
| SNAGS with thoracic postural correction techniquesthoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15-20 seconds with 10 repetitions of each stretch per session | Other | SNAGS with thoracic postural correction techniques, sustained natural apophyseal glides |
Primary outcome
Visual Analog scale (VAS)
Time frame: four weeks
The VAS is a 10- cm graduated line. Each participant will self-assess the intensity of her pain. Patients in each group will be instructed to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far-left end indicates "no pain" and the far right end indicates worst pain ever
Neck Disability Index (NDI)
Time frame: for four weeks
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain.
Headache Impact Test
Time frame: for four weeks
Headache Impact Test is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function.
Cervical ROM --Universal Goniometer
Time frame: four weeks
A large universal goniometer having a stationary arm and a moving arm of 12 inch and full circle body will be used for measuring cervical range of motion.
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 19 Sep 2022.
- Background: PubMed 24421621Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.
- Background: PubMed 22460941Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
- Background: PubMed 26852024Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Background: PubMed 24976747Fernandez-de-Las-Penas C, Courtney CA. Clinical reasoning for manual therapy management of tension type and cervicogenic headache. J Man Manip Ther. 2014 Feb;22(1):44-50. doi: 10.1179/2042618613Y.0000000050.
- Background: PubMed 24491791McDowell JM, Johnson GM, Hetherington BH. Mulligan Concept manual therapy: standardizing annotation. Man Ther. 2014 Oct;19(5):499-503. doi: 10.1016/j.math.2013.12.006. Epub 2014 Jan 10.
- Background: PubMed 15754599McDonnell MK, Sahrmann SA, Van Dillen L. A specific exercise program and modification of postural alignment for treatment of cervicogenic headache: a case report. J Orthop Sports Phys Ther. 2005 Jan;35(1):3-15. doi: 10.2519/jospt.2005.35.1.3.
- Background: PubMed 31740859Tul Ain SQ, Shakil Ur Rehman S, Maryam M, Kiani SK. Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial. J Pak Med Assoc. 2019 Nov;69(11):1584-1587. doi: 10.5455/JPMA.274875..
- Background: PubMed 24792139Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
- Background: PubMed 18803999Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
- 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.
Maria Khalid, MSOMPT principal investigator
Riphah International University
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 and SNAGS with thoracic postural correction techniques in people with Cervicogenic Headache, run by Riphah International University 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 4 inclusion and 6 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 19 Sep 2022. 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?
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?
Visual Analog scale (VAS) (time frame: four 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?
On the ClinicalTrials.gov record for NCT04993950, which also lists 9 linked publications.
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 19 Sep 2022.