NCT04816448

Brief Summary

Cervicogenic headache is a secondary form of headache that occurs from the upper cervical spine and atlanto-occipital joint. A CGH is a frequent source of chronic headache and is frequently misdiagnosed .Cervicogenic headache is among the most common problem affecting four times more women as compared to males and is considered by some painful feeling in the head , neck ,temporal area, frontal area and around the eyes areas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

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

April 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

March 24, 2021

Last Update Submit

August 27, 2021

Conditions

Cervicogenic Headache

Keywords

Cervicogenic headachePain Numerical Rating ScaleNeck disability index

Outcome Measures

Primary Outcomes (2)

  • Pain Numeric Rating Scale

    Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. \*P \< 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10.

    4 months

  • NECK DISABILITY INDEX

    the overall score range is between 0 and 50, 0 being no to little pain and discomfort while 50 being the severest degree of pain and disability with complete activity limitation.

    4 months

Study Arms (2)

Studygroup

EXPERIMENTAL

cervical mobilization (Headache SNAG) with baseline treatment (Hot pack for 10 minutes, TENS 10 minutes, Neck isometrics and stretching).

Other: cervical mobilization (Headache SNAG)

Control Group

ACTIVE COMPARATOR

Sub-occipital myofascial release with baseline treatment (Hot pack for 10 minutes, TENS for 10 minutes, Neck isometrics and stretching

Other: Sub-occipital myofascial release

Interventions

cervical mobilization (Headache SNAG)OTHER

For cervical mobilization the patient's position is sitting on a chair in the erect posture. The therapist handled C2 spinous process with the middle phalanx of one hand. With the other hand, he performed ventral glide asked the patient to move neck in all directions (Flexion, Extension, Side bending and rotation) one by one and then slowly move the neck back to its starting position while the therapist maintained the ventral glide.

Studygroup
Sub-occipital myofascial releaseOTHER

For the application of the technique , the patient position is supine lying with the head fully supported on therapist's hands and therapist places 3 middle fingers just inferior to the nuchal line, lifts the fingers tips towards the ceiling while resting the head on the table and then therapist will apply a gentle upward pull. This procedure done for 2 to 3 minutes and 5 to 7 repetitions, 3 sessions per week on alternate days were given for 6 weeks. Evaluation was done before treatment, during treatment at 4th week and after treatment at 6th week. Outcomes will be measured by NDI, PNRS and Universal Goniometer.

Control Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both Genders
  • Age between 20 to 75 Years
  • Neck pain referring the unilateral pain to the sub-occipital region and head.
  • Headache intensifying upon manual pressure to upper cervical joints and muscles
  • With the cranio-cervical Flexion rotation exam, neck pain and ipsilateral headache and restriction of C1 and C2 rotation.

You may not qualify if:

  • Tension headache (Headache on both sides)
  • If the patient not tolerate the cranio-cervical Flexion rotation test.
  • Patients presents with autonomic symptoms like visual disturbance, vertigo, dizziness.
  • If the physiotherapeutic modalities used for head pain in the last 6 months.
  • Headache other than cervical origins.
  • Clinically diagnosed as case of cervical radiculopathy or myelopathy.
  • Extreme cervical discomfort due to disk herniation, stenosis of the spinal canal and cervical arthritis.
  • Each other disorder that may be contraindicated in the upper cervical area of myofascial release.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • Singh LR, Chauhan V. Comparison of efficacy of myofascial release and positional release therapy in tension type headache. JMSCR. 2014;2(9):2372-9.

    BACKGROUND

  • Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.

    PMID: 24421621BACKGROUND

  • Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.

    PMID: 15928349BACKGROUND

  • Antonaci F, Sjaastad O. Cervicogenic headache: a real headache. Curr Neurol Neurosci Rep. 2011 Apr;11(2):149-55. doi: 10.1007/s11910-010-0164-9.

    PMID: 21125430BACKGROUND

  • Fredriksen TA, Salvesen R, Stolt-Nielsen A, Sjaastad O. Cervicogenic headache: long-term postoperative follow-up. Cephalalgia. 1999 Dec;19(10):897-900. doi: 10.1046/j.1468-2982.1999.1910897.x.

    PMID: 10668109BACKGROUND

  • 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

  • Bovim G, Berg R, Dale LG. Cervicogenic headache: anesthetic blockades of cervical nerves (C2-C5) and facet joint (C2/C3). Pain. 1992 Jun;49(3):315-320. doi: 10.1016/0304-3959(92)90237-6.

    PMID: 1408296BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Maryam Shabbir, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 25, 2021

Study Start

April 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)