Cervicogenic HeadacheNCT05434468
Sustained Neutral Apophyseal Glides Half Rotation Technique and Gong's Mobilizations in Cervicogenic Headache
A study testing Sustained neutral apophyseal glides in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cervicogenic headache is a very incessant issue that is often faced by general population.Cervicogenic headache is a significant issue in patients with upper cervical dysfunction. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Sustained neutral apophyseal glides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 5 Sep 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Headache with neck stiffness and pain.
- Headache for the past 3 months at least once per week
- Aged 25-45 years
- Chronic neck pain for more than 3 months
- baseline NDI score of atleast
Who cannot join
- Physiotherapy or chiropractic treatment in the past 3 months
- Headache with autonomic involvement, dizziness, or visual disturbance
- Congenital conditions of the cervical spine
- Contraindication to manipulative therapy
- Involvement in litigation or compensation
- Inability to tolerate the flexion-rotation test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Sustained Neutral Apophyseal Glides Half Rotation Technique and Gong's Mobilizations in Cervicogenic Headache
Cervicogenic headache is a very incessant issue that is often faced by general population.Cervicogenic headache is a significant issue in patients with upper cervical dysfunction. However, its physical therapy management is a subject of debate.As the Comparative effects of SNAGs half rotation technique and Gong's mobilizations has never been investigated in patients with cervicogenic headache and neck pain , the aim of this study is to investigate the effects of these treatments on two study groups(Group A\&B) respectively. This study will be a randomized clinical trial and will be conducted in D.H.Q Sahiwal . The study will be completed within the time duration of six months .Non- probability convenience sampling technique will be used to collect the data. The sample size of 30 patients will be taken in this study , aged 25-45 years, will allocate to two groups, Group A (Sustained neutral apophyseal glide half rotation technique) Group B (Gong's mobilization).cervical Sustained neutral apophyseal glide half rotation technique (SNAG) half rotation technique will be performed with the patient sitting on a chair in the erect posture. The thumb placement of therapist will be over the transverse process of C1. Then, glide will be applied ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 6 weeks.Group B will be treated three times in a week for 4 weeks.Group B will get Gong's mobilization for 15-20 mins.Participants will be treated 3 times per week for 6 weeks. Pre and Post treatment readings will be taken in 1st session and 6th week respectively. Assessment will done via flexion rotation test (FRT),6-item Headache Impact scale and neck disability index. Neck Disability Index will use to examine neck pain intensity and cervicogenic headache symptoms.
Read the detailed description
Cervicogenic headache is a very incessant issue that is often faced by general population.Cervicogenic headache is a significant issue in patients with upper cervical dysfunction. However, its physical therapy management is a subject of debate.As the Comparative effects of SNAGs half rotation technique and Gong's mobilizations has never been investigated in patients with cervicogenic headache and neck pain , the aim of this study is to investigate the effects of these treatments on two study groups(Group A\&B) respectively. This study will be a randomized clinical trial and will be conducted in D.H.Q Sahiwal . The study will be completed within the time duration of six months .Non- probability convenience sampling technique will be used to collect the data. The sample size of 30 patients will be taken in this study , aged 25-45 years, will allocate to two groups, Group A (Sustained neutral apophyseal glide half rotation technique) Group B (Gong's mobilization).cervical Sustained neutral apophyseal glide half rotation technique (SNAG) half rotation technique will be performed with the patient sitting on a chair in the erect posture. The thumb placement of therapist will be over the transverse process of C1. Then, glide will be applied ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 6 weeks.Group B will be treated three times in a week for 4 weeks.Group B will get Gong's mobilization for 15-20 mins.Participants will be treated 3 times per week for 6 weeks. Pre and Post treatment readings will be taken in 1st session and 6th week respectively. Assessment will done via flexion rotation test (FRT),6-item Headache Impact scale and neck disability index. Neck Disability Index will use to examine neck pain intensity and cervicogenic headache symptoms. The 6-item Headache Impact Test scale will use to examine headache severity and its adverse effects on social life and functions. Flexion-Rotation Test will use to assess rotation range of motion.
- Conditions
- Cervicogenic Headache
- Being tested
- Sustained neutral apophyseal glides
- Keywords
- cervicogenic headache ,Gong's mobilization ,
- 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 neutral apophyseal glidesOther
Also called gong mobilization
gong mobilization
| Study group | Role | What they receive |
|---|---|---|
| Sustained neutral apophyseal glides group | Experimental | Sustained neutral apophyseal glides will apply on this group. Receives: Other: Sustained neutral apophyseal glides |
| Gong mobilization | Experimental | mobilization technique Receives: Other: Sustained neutral apophyseal glides |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck disablity index
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. ... A higher NDI score means the greater a patient's perceived disability due to neck pain. The minimally clinically important change by patients has been found to be 5 or 10%.
Measured: 6 months
flexion rotation test
The passive flexion-rotation test (FRT-P) is performed with the patient supine. An examiner passively positions the patient's neck into full flexion to pre-tension the structures of the middle and lower cervical spine, then the patient's head is passively rotated each direction while the flexed position is maintained.
Measured: 6 months
HIT questionnaire
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the
Measured: 6 months
goniometer
for measuring range of motion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start15 Apr 2022
- Primary completion15 Aug 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Rabiya Noor, PhD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434468
- Sponsor's protocol ID
- REC/RCR&AHS/21/0133
- Status last verified
- Dec 2022
- First submitted
- 15 Apr 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ylinen J, Nikander R, Nykanen M, Kautiainen H, Hakkinen A. Effect of neck exercises on cervicogenic headache: a randomized controlled trial. J Rehabil Med. 2010 Apr;42(4):344-9. doi: 10.2340/16501977-0527.
PubMed 20461336Mohamed AA, Shendy WS, Semary M, Mourad HS, Battecha KH, Soliman ES, Sayed SHE, Mohamed GI. Combined use of cervical headache snag and cervical snag half rotation techniques in the treatment of cervicogenic headache. J Phys Ther Sci. 2019 Apr;31(4):376-381. doi: 10.1589/jpts.31.376. Epub 2019 Apr 1.
PubMed 31037013
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Sustained Neutral Apophyseal Glides Half Rotation Technique and Gong's Mobilizations in Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05434468
- Acronym / sponsor ID
- REC/RCR&AHS/21/0133
- Conditions
- Cervicogenic Headache
- Keywords
- cervicogenic headache ,Gong's mobilization ,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 28 Jun 2022 (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 very incessant issue that is often faced by general population.Cervicogenic headache is a significant issue in patients with upper cervical dysfunction. However, its physical therapy management is a subject of debate.As the Comparative effects of SNAGs half rotation technique and Gong's mobilizations has never been investigated in patients with cervicogenic headache and neck pain , the aim of this study is to investigate the effects of these treatments on two study groups(Group A\&B) respectively. This study will be a randomized clinical trial and will be conducted in D.H.Q Sahiwal . The study will be completed within the time duration of six months .Non- probability convenience sampling technique will be used to collect the data. The sample size of 30 patients will be taken in this study , aged 25-45 years, will allocate to two groups, Group A (Sustained neutral apophyseal glide half rotation technique) Group B (Gong's mobilization).cervical Sustained neutral apophyseal glide half rotation technique (SNAG) half rotation technique will be performed with the patient sitting on a chair in the erect posture. The thumb placement of therapist will be over the transverse process of C1. Then, glide will be applied ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 6 weeks.Group B will be treated three times in a week for 4 weeks.Group B will get Gong's mobilization for 15-20 mins.Participants will be treated 3 times per week for 6 weeks. Pre and Post treatment readings will be taken in 1st session and 6th week respectively. Assessment will done via flexion rotation test (FRT),6-item Headache Impact scale and neck disability index. Neck Disability Index will use to examine neck pain intensity and cervicogenic headache symptoms.
Detailed description
Cervicogenic headache is a very incessant issue that is often faced by general population.Cervicogenic headache is a significant issue in patients with upper cervical dysfunction. However, its physical therapy management is a subject of debate.As the Comparative effects of SNAGs half rotation technique and Gong's mobilizations has never been investigated in patients with cervicogenic headache and neck pain , the aim of this study is to investigate the effects of these treatments on two study groups(Group A\&B) respectively. This study will be a randomized clinical trial and will be conducted in D.H.Q Sahiwal . The study will be completed within the time duration of six months .Non- probability convenience sampling technique will be used to collect the data. The sample size of 30 patients will be taken in this study , aged 25-45 years, will allocate to two groups, Group A (Sustained neutral apophyseal glide half rotation technique) Group B (Gong's mobilization).cervical Sustained neutral apophyseal glide half rotation technique (SNAG) half rotation technique will be performed with the patient sitting on a chair in the erect posture. The thumb placement of therapist will be over the transverse process of C1. Then, glide will be applied ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 6 weeks.Group B will be treated three times in a week for 4 weeks.Group B will get Gong's mobilization for 15-20 mins.Participants will be treated 3 times per week for 6 weeks. Pre and Post treatment readings will be taken in 1st session and 6th week respectively. Assessment will done via flexion rotation test (FRT),6-item Headache Impact scale and neck disability index. Neck Disability Index will use to examine neck pain intensity and cervicogenic headache symptoms. The 6-item Headache Impact Test scale will use to examine headache severity and its adverse effects on social life and functions. Flexion-Rotation Test will use to assess rotation range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained neutral apophyseal glides group | Experimental | Other: Sustained neutral apophyseal glidesSustained neutral apophyseal glides will apply on this group. |
| Gong mobilization | Experimental | Other: Sustained neutral apophyseal glidesmobilization technique |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Headache with neck stiffness and pain.
- Headache for the past 3 months at least once per week
- Aged 25-45 years
- Chronic neck pain for more than 3 months
- baseline NDI score of atleast
Key exclusion criteria (6 listed)
- Physiotherapy or chiropractic treatment in the past 3 months
- Headache with autonomic involvement, dizziness, or visual disturbance
- Congenital conditions of the cervical spine
- Contraindication to manipulative therapy
- Involvement in litigation or compensation
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 neutral apophyseal glidesAlso: gong mobilizationgong mobilization | Other | Gong mobilization, Sustained neutral apophyseal glides group |
Primary outcome
neck disablity index
Time frame: 6 months
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. ... A higher NDI score means the greater a patient's perceived disability due to neck pain. The minimally clinically important change by patients has been found to be 5 or 10%.
flexion rotation test
Time frame: 6 months
The passive flexion-rotation test (FRT-P) is performed with the patient supine. An examiner passively positions the patient's neck into full flexion to pre-tension the structures of the middle and lower cervical spine, then the patient's head is passively rotated each direction while the flexed position is maintained.
HIT questionnaire
Time frame: 6 months
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the
goniometer
Time frame: 6 months
for measuring 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 8 Dec 2022.
- Background: PubMed 20461336Ylinen J, Nikander R, Nykanen M, Kautiainen H, Hakkinen A. Effect of neck exercises on cervicogenic headache: a randomized controlled trial. J Rehabil Med. 2010 Apr;42(4):344-9. doi: 10.2340/16501977-0527.
- Background: PubMed 31037013Mohamed AA, Shendy WS, Semary M, Mourad HS, Battecha KH, Soliman ES, Sayed SHE, Mohamed GI. Combined use of cervical headache snag and cervical snag half rotation techniques in the treatment of cervicogenic headache. J Phys Ther Sci. 2019 Apr;31(4):376-381. doi: 10.1589/jpts.31.376. Epub 2019 Apr 1.
- 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.
Dr. Rabiya Noor, PhD study chair
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 neutral apophyseal glides 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 5 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 8 Dec 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?
neck disablity index (time frame: 6 months). 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 NCT05434468, which also lists 2 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 8 Dec 2022.