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Cervicogenic HeadacheNCT04816448

Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache

A study testing cervical mobilization (Headache SNAG) and Sub-occipital myofascial release in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
cervical mobilization (Headache SNAG) and Sub-occipital myofascial release
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePakistan
Study dates
1 Apr 2020to 30 Dec 2020
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah Rehabilitation Center

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Read the detailed description

There is also pain in the face and ipsilateral head that does not alternate the sides, but when cervicogenic headache becomes severe, in some patients pain may occasionally feel it on the other side of the head. Diagnosis of cervicogenic headache depends on the detailed patient's history, manual examination and the assessment of nervous system. After the diagnostic block test disappearance of headache shows that the source of this pain is cervical spine. Cervical flexion rotation test is a very useful diagnostic measure in cervical movement restriction and differential diagnosis of cervicogenic headache. Physical therapy is considered most effective treatment of cervicogenic headache in which different techniques manipulative therapy, mobilization of cervical vertebrae, stretches and sub-occipital myofascial release used.

Objective: To determine the effects of sub-occipital myofascial release in patients with cervicogenic headache.

Methods: This study was randomized control trial and on the basis of inclusion criteria, 22 patients were included and were randomized through sealed envelope in two groups A and B. Group A was given sub-occipital myofascial release along with conventional therapy while group B was given cervical mobilization and conventional therapy and both groups were assessed by using Neck Disability Index(NDI), Pain Numerical Rating Scale(PNRS) and cervical range of motion by goniometer at baseline, Week(1-4) and 8th week( last week) .The data was analyzed using SPSS 21.

Being tested
cervical mobilization (Headache SNAG), Sub-occipital myofascial release
Keywords
Cervicogenic headache, Pain Numerical Rating Scale, Neck disability index
Medical subject headings
Post-Traumatic Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04816448
Study groupRoleWhat they receive
StudygroupExperimentalcervical mobilization (Headache SNAG) with baseline treatment (Hot pack for 10 minutes, TENS 10 minutes, Neck isometrics and stretching).
Receives: Other: cervical mobilization (Headache SNAG)
Control GroupActive comparatorSub-occipital myofascial release with baseline treatment (Hot pack for 10 minutes, TENS for 10 minutes, Neck isometrics and stretching
Receives: Other: Sub-occipital myofascial release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start1 Apr 2020
  3. Primary completion30 Nov 2020
  4. Study completion30 Dec 2020

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816448
Sponsor's protocol ID
REC/Lhr/1062
Status last verified
Aug 2021
First submitted
24 Mar 2021
Last updated
30 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 24421621

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

    PubMed 15928349

  • 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.

    PubMed 21125430

  • 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.

    PubMed 10668109

  • 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.

    PubMed 11403743

  • 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.

    PubMed 1408296

Questions about this trial

What is this clinical trial studying?

A study testing cervical mobilization (Headache SNAG) and Sub-occipital myofascial release 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 5 inclusion and 8 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 30 Aug 2021. 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?

Pain Numeric Rating Scale (time frame: 4 months). The study lists 2 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 NCT04816448, which also lists 7 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 30 Aug 2021.

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