NCT06459726

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

muscle strengthmanual therapyunilateral headaches

Outcome Measures

Primary Outcomes (4)

  • NPRS

    Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain

    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

    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.

    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.

    6th week

Study Arms (2)

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.

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

Other: SNAGS

Interventions

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

shi style mobilisation
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

SNAGS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 31580705BACKGROUND
  • 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.

    PMID: 35294051BACKGROUND
  • 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.

    PMID: 28767566BACKGROUND
  • 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.

    PMID: 14588366BACKGROUND
  • 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.

    PMID: 11403743BACKGROUND

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • rabbiya noor, phd

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

May 7, 2024

Primary Completion

July 1, 2024

Study Completion

August 30, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations