- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459726
Effects of Shi Style Cervical Mobilization Versus SNAGS in Patients With Cervicogenic Headache
Effects of Shi Style Cervical Mobilization Versus Sustained Natural Apophyseal Glides on Pain,Strength and Functional Disability in Patients With Cervicogenic Headache.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Jinnah Hospital Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: shi style mobilisation
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.
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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
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|
Active Comparator: SNAGS
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 |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Deep Neck flexors strength by pressure Biofeedback
Time Frame: 6th week
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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
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6th week
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Dizziness Handicap Inventory
Time Frame: 6th week
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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.
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6th week
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Quality of life SF36
Time Frame: 6th week
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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.
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6th week
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NPRS
Time Frame: 6th week
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Numeric Pain rating scale is a scale for pain starting from 0-10.
where 0 indicate no pain and 10 indicate severe pain
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6th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: rabbiya noor, phd, Study Principal Investigator
Publications and helpful links
General Publications
- Bogduk 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.
- Haldeman 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.
- 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.
- Nunez-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.
- Cui 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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