Cervicogenic HeadacheNCT06459726
Effects of Shi Style Cervical Mobilization Versus SNAGS in Patients With Cervicogenic Headache
A study testing shi style mobilization and SNAGS in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cervicogenic headache (CGH) manifests as unilateral neck pain referred from the neck's soft tissues or bony structures. The aim of this study will be to compare the effectiveness of Shi style cervical mobilization versus Sustained Natural Apophyseal Glides on pain, strength and functional disability in patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- shi style mobilization and SNAGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 7 May 2024to 30 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18 to 65 years.
- Both male and females.
- Unilateral dominant headache.
- Positive International Headache Society Diagnostic Criteria (IHS) for cervicogenic headache.
- Decrease strength deep neck flexors by pressure biofeedback.
- Tenderness of the upper 3 cervical spine joints.
Who cannot join
- • Patients who received any treatment for CGH within the previous 3 months that would interfere with this study.
- Pregnant females.
- Inflammatory conditions in which manual therapy is contraindicated(29).
- Cancer or brain diseases.
- Recent fracture or injuries.
- Congenital conditions of the cervical spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Shi Style Cervical Mobilization Versus Sustained Natural Apophyseal Glides on Pain,Strength and Functional Disability in Patients With Cervicogenic Headache.
Cervicogenic headache (CGH) manifests as unilateral neck pain referred from the neck's soft tissues or bony structures. The aim of this study will be to compare the effectiveness of Shi style cervical mobilization versus Sustained Natural Apophyseal Glides on pain, strength and functional disability in patients with Cervicogenic Headache.
Read the detailed description
A Randomized Clinical Trial will be conducted at Jinnah hospital Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with shi style mobilizations with 6 sesions over 4 weeks for 20minutes. Group B will be treated with Sustained Natural Apophyseal Glides with Number of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10seconds. Outcome measures will be conducted through NPRS for pain , Deep Neck flexors strength by pressure Biofeedback, Dizziness Handicap Inventory for pain and change in dizziness, NDI for functional impairments and SF 36 for quality of life.Data will be analyzed through SPSS software version 25 .
- Conditions
- Cervicogenic Headache
- Being tested
- shi style mobilization, SNAGS
- Keywords
- muscle strength, manual therapy, unilateral headaches
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shi style mobilizationOther
Step 1 soothing tendon stepTherapist will aerate patient's neck 3 to 6 times.Step 2 moblization step Therapist will apply low velocity small amplitude oscillatory movement without thrust. Head will be in 45 degrees of flexion or extension. Repeat this for 3 to 6 times. Then distraction force is applied to the cervical. Step 3 dredging collateral step Therapist holds thenar and hypothenar muscles of patient's hand on affected side and gently shook the upper limb ebb and flow with small shaking and high frequency. Repeat the procedure 3 times 6 sesions over 2 weeks for 20minutes
SNAGSOther
Patient will receive sustained natural apophyseal glides as described by brian mulligan. Patient position will be upright sitting when therapist will apply a sustained passive assesory glide while patient moves actively through available physiological range of motion in the direction in which symptoms are produced. the headache SNAG technique will be performed with the patient sitting on a chair in the erect posture. The therapist will handle C2 spinous process with the middle phalanx of one hand. With the other hand, he will perform ventral gliding on C2 for 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Patient will be asked to report dizziness or any other symptom after procedure. If patient reports symptom then angle of application is changed to ensure symptom free treatment in all patientsNumber of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10second
| Study group | Role | What they receive |
|---|---|---|
| shi style mobilisation | Active comparator | In this group patient will receive Shi style cervical mobilization SCM including three crucial steps soothing tendon step, mobilization step and dredging collateral step 6 sessions over 2 weeks for 20 minutes. Receives: Other: shi style mobilization |
| SNAGS | Active comparator | Patient will receive sustained natural apophyseal glides as described by brian mulligan. Patient position will be upright sitting when therapist will apply a sustained passive assesory glide while patient moves actively through available physiological range of motion in the direction in which symptoms are produced(25).
the headache SNAG technique will be performed with the patient sitting on a chair in the erect posture. The therapist will handle C2 spinous process with the middle phalanx of one hand. With the other hand, he will perform ventral gliding on C2 for 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Patient will be asked to report dizziness or any other symptom after procedure. If patient reports symptom then angle of application is changed to ensure symptom free treatment in all patients. Number of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10seconds Receives: Other: SNAGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
Measured: 6th week
Deep Neck flexors strength by pressure Biofeedback
Subjects will be positioned in supine lying, and the air unit of pressure biofeedback will be placed at the posterior aspect of the cervical spine just below the occiput and inflated to a baseline of 20 mmHg. They will be instructed to perform the cranio-cervical flexion movement such that the pressure rose to 22 mmHg and will hold this position for 10 seconds. A rest of 30 seconds will be provided, and the whole procedure will be repeated for 24, 26, 28, and 30 mmHg. Final reading will be taken when the subject is not able to hold the specific pressure for 10 seconds. Before the test, subjects will be given enough time to practice and examiner will observe for any substitution movements during the test. Test will be considered poor if subjects could not hold the position at 26 mmHg
Measured: 6th week
Dizziness Handicap Inventory
The primary outcome will be the score on the Dizziness Handicap Inventory (DHI). The DHI Is a highly reliable and responsive tool. This questionnaire is validated and shows a high test-retest reliability (ICC = 0.98) he highest available score is 100, indicating the maximum level of self-perceived handicap (0-30 "low handicap", 30-60 "moderate handicap" and +60 "severe handicap")(32). The DHI consists of 25 items with 3 response levels that are categorized into subgroups as functional 36 points, emotional 36 points, and physical 28 points.
Measured: 6th week
Quality of life SF36
SF-36 was used to assess participants' health-related quality of life. It contains 36 questions divided into eight dimensions including physical functioning (10 items), role limitations due to physical health problems (four items), social functioning (two items), bodily pain (two items), general mental health (five items), vitality (four items), role limitations due to emotional health problems (three items), general health perceptions (five items), and reported health transition (one item). The score for each question will be the weight sum of the questions in each dimension. Physical (physical health, role physical, bodily pain, general health) and mental component summary scores (vitality, social functioning, role-emotional, and emotional well-being) were calculated(37). A total score can range from 0 to 100, where a higher score indicates better health status Assessments will be performed before, during, and after intervention.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start7 May 2024
- Primary completion1 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rabbiya noor, phd, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459726
- Sponsor's protocol ID
- REC/RCR&AHS/23/0182
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao M, Tang ZY, Cui XJ, Sun YL, Ye XL, Wang P, Zhong WH, Zhang RC, Li HY, Hu ZJ, Wang WM, Qiao WP, Li J, Gao Y, Shi Q, Wang YJ. Shi-Style Cervical Mobilizations Versus Massage for Cervical Vertigo: A Multicenter, Randomized, Controlled Clinical Trial. J Altern Complement Med. 2020 Jan;26(1):58-66. doi: 10.1089/acm.2019.0113. Epub 2019 Oct 3.
PubMed 31580705Nunez-Cabaleiro P, Leiros-Rodriguez R. Effectiveness of manual therapy in the treatment of cervicogenic headache: A systematic review. Headache. 2022 Mar;62(3):271-283. doi: 10.1111/head.14278. Epub 2022 Mar 16.
PubMed 35294051Cui XJ, Yao M, Ye XL, Wang P, Zhong WH, Zhang RC, Li HY, Hu ZJ, Tang ZY, Wang WM, Qiao WP, Sun YL, Li J, Gao Y, Shi Q, Wang Y. Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial. Medicine (Baltimore). 2017 Aug;96(31):e7276. doi: 10.1097/MD.0000000000007276.
PubMed 28767566Haldeman S, Dagenais S. Cervicogenic headaches: a critical review. Spine J. 2001 Jan-Feb;1(1):31-46. doi: 10.1016/s1529-9430(01)00024-9.
PubMed 14588366Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
PubMed 11403743
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shi Style Cervical Mobilization Versus Sustained Natural Apophyseal Glides on Pain,Strength and Functional Disability in Patients With Cervicogenic Headache.
- ClinicalTrials.gov ID
- NCT06459726
- Acronym / sponsor ID
- REC/RCR&AHS/23/0182
- Conditions
- Cervicogenic Headache
- Keywords
- muscle strength, manual therapy, unilateral headaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Jun 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 (CGH) manifests as unilateral neck pain referred from the neck's soft tissues or bony structures. The aim of this study will be to compare the effectiveness of Shi style cervical mobilization versus Sustained Natural Apophyseal Glides on pain, strength and functional disability in patients with Cervicogenic Headache.
Detailed description
A Randomized Clinical Trial will be conducted at Jinnah hospital Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with shi style mobilizations with 6 sesions over 4 weeks for 20minutes. Group B will be treated with Sustained Natural Apophyseal Glides with Number of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10seconds. Outcome measures will be conducted through NPRS for pain , Deep Neck flexors strength by pressure Biofeedback, Dizziness Handicap Inventory for pain and change in dizziness, NDI for functional impairments and SF 36 for quality of life.Data will be analyzed through SPSS software version 25 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shi style mobilisation | Active comparator | Other: shi style mobilizationIn this group patient will receive Shi style cervical mobilization SCM including three crucial steps soothing tendon step, mobilization step and dredging collateral step 6 sessions over 2 weeks for 20 minutes. |
| SNAGS | Active comparator | Other: SNAGSPatient will receive sustained natural apophyseal glides as described by brian mulligan. Patient position will be upright sitting when therapist will apply a sustained passive assesory glide while patient moves actively through available physiological range of motion in the direction in which symptoms are produced(25). the headache SNAG technique will be performed with the patient sitting on a chair in the erect posture. The therapist will handle C2 spinous process with the middle phalanx of one hand. With the other hand, he will perform ventral gliding on C2 for 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Patient will be asked to report dizziness or any other symptom after procedure. If patient reports symptom then angle of application is changed to ensure symptom free treatment in all patients. Number of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10seconds |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age:18 to 65 years.
- Both male and females.
- Unilateral dominant headache.
- Positive International Headache Society Diagnostic Criteria (IHS) for cervicogenic headache.
- Decrease strength deep neck flexors by pressure biofeedback.
Key exclusion criteria (6 listed)
- • Patients who received any treatment for CGH within the previous 3 months that would interfere with this study.
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 |
|---|---|---|
| shi style mobilizationStep 1 soothing tendon stepTherapist will aerate patient's neck 3 to 6 times.Step 2 moblization step Therapist will apply low velocity small amplitude oscillatory movement without thrust. Head will be in 45 degrees of flexion or extension. Repeat this for 3 to 6 times. Then distraction force is applied to the cervical. Step 3 dredging collateral step Therapist holds thenar and hypothenar muscles of patient's hand on affected side and gently shook the upper limb ebb and flow with small shaking and high frequency. Repeat the procedure 3 times 6 sesions over 2 weeks for 20minutes | Other | shi style mobilisation |
| SNAGSPatient will receive sustained natural apophyseal glides as described by brian mulligan. Patient position will be upright sitting when therapist will apply a sustained passive assesory glide while patient moves actively through available physiological range of motion in the direction in which symptoms are produced. the headache SNAG technique will be performed with the patient sitting on a chair in the erect posture. The therapist will handle C2 spinous process with the middle phalanx of one hand. With the other hand, he will perform ventral gliding on C2 for 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Patient will be asked to report dizziness or any other symptom after procedure. If patient reports symptom then angle of application is changed to ensure symptom free treatment in all patientsNumber of repetitions are increased gradually from 6 to 10 and end physiological movement is maintained for 10second | Other | SNAGS |
Primary outcome
NPRS
Time frame: 6th week
Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
Deep Neck flexors strength by pressure Biofeedback
Time frame: 6th week
Subjects will be positioned in supine lying, and the air unit of pressure biofeedback will be placed at the posterior aspect of the cervical spine just below the occiput and inflated to a baseline of 20 mmHg. They will be instructed to perform the cranio-cervical flexion movement such that the pressure rose to 22 mmHg and will hold this position for 10 seconds. A rest of 30 seconds will be provided, and the whole procedure will be repeated for 24, 26, 28, and 30 mmHg. Final reading will be taken when the subject is not able to hold the specific pressure for 10 seconds. Before the test, subjects will be given enough time to practice and examiner will observe for any substitution movements during the test. Test will be considered poor if subjects could not hold the position at 26 mmHg
Dizziness Handicap Inventory
Time frame: 6th week
The primary outcome will be the score on the Dizziness Handicap Inventory (DHI). The DHI Is a highly reliable and responsive tool. This questionnaire is validated and shows a high test-retest reliability (ICC = 0.98) he highest available score is 100, indicating the maximum level of self-perceived handicap (0-30 "low handicap", 30-60 "moderate handicap" and +60 "severe handicap")(32). The DHI consists of 25 items with 3 response levels that are categorized into subgroups as functional 36 points, emotional 36 points, and physical 28 points.
Quality of life SF36
Time frame: 6th week
SF-36 was used to assess participants' health-related quality of life. It contains 36 questions divided into eight dimensions including physical functioning (10 items), role limitations due to physical health problems (four items), social functioning (two items), bodily pain (two items), general mental health (five items), vitality (four items), role limitations due to emotional health problems (three items), general health perceptions (five items), and reported health transition (one item). The score for each question will be the weight sum of the questions in each dimension. Physical (physical health, role physical, bodily pain, general health) and mental component summary scores (vitality, social functioning, role-emotional, and emotional well-being) were calculated(37). A total score can range from 0 to 100, where a higher score indicates better health status Assessments will be performed before, during, and after intervention.
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 27 Dec 2024.
- Background: PubMed 31580705Yao M, Tang ZY, Cui XJ, Sun YL, Ye XL, Wang P, Zhong WH, Zhang RC, Li HY, Hu ZJ, Wang WM, Qiao WP, Li J, Gao Y, Shi Q, Wang YJ. Shi-Style Cervical Mobilizations Versus Massage for Cervical Vertigo: A Multicenter, Randomized, Controlled Clinical Trial. J Altern Complement Med. 2020 Jan;26(1):58-66. doi: 10.1089/acm.2019.0113. Epub 2019 Oct 3.
- Background: PubMed 35294051Nunez-Cabaleiro P, Leiros-Rodriguez R. Effectiveness of manual therapy in the treatment of cervicogenic headache: A systematic review. Headache. 2022 Mar;62(3):271-283. doi: 10.1111/head.14278. Epub 2022 Mar 16.
- Background: PubMed 28767566Cui XJ, Yao M, Ye XL, Wang P, Zhong WH, Zhang RC, Li HY, Hu ZJ, Tang ZY, Wang WM, Qiao WP, Sun YL, Li J, Gao Y, Shi Q, Wang Y. Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial. Medicine (Baltimore). 2017 Aug;96(31):e7276. doi: 10.1097/MD.0000000000007276.
- Background: PubMed 14588366Haldeman S, Dagenais S. Cervicogenic headaches: a critical review. Spine J. 2001 Jan-Feb;1(1):31-46. doi: 10.1016/s1529-9430(01)00024-9.
- Background: PubMed 11403743Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
- 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.
rabbiya noor, phd principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shi style mobilization and SNAGS 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 6 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 27 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?
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?
NPRS (time frame: 6th week). 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 NCT06459726, which also lists 5 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 27 Dec 2024.