Effects of Shi Style Cervical Mobilization Versus SNAGS in Patients With Cervicogenic Headache

Cervicogenic Headache Clinical Trial

Official title:

Effects of Shi Style Cervical Mobilization Versus Sustained Natural Apophyseal Glides on Pain,Strength and Functional Disability in Patients With Cervicogenic Headache.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459726
• Other study ID #: REC/RCR&AHS/23/0182
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: imran amjad, phd*
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Cervicogenic Headache.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Other:
• shi style mobilization
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
• 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. 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

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPRS	Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	6th week
Primary	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	6th week
Primary	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.	6th week
Primary	NDI	This questionnaire will be used to assess disability. It comprises of 10 items. Out of which 7 are related to daily living activities, 2of them related to pain and 1 related to concentration. Each item is scored from 0 to 5.. the lowest score of each item is 0 and the highest is 5, the higher the score the serious the dysfunction . The specific judgment is 0-20% indicates mild dysfunction, 21-40% indicates moderate dysfunction, 41-60% indicates severe dysfunction, 61-80% indicates extremely severe dysfunction, and 81-100% indicates complete dysfunction The Neck Disability Index exhibited excellent reliability (ICC ¼ 0.92; [95 % CI: 0.46-0.97]) validity (p < 0.001) in this headache population(30). Total score is expressed as a percentage, with higher scores related to greater disability.	6th week
Primary	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.	6th week