- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816448
Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache
Study Overview
Status
Conditions
Intervention / Treatment
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.
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
- Riphah Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Studygroup
cervical mobilization (Headache SNAG) with baseline treatment (Hot pack for 10 minutes, TENS 10 minutes, Neck isometrics and stretching).
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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.
|
Active Comparator: Control Group
Sub-occipital myofascial release with baseline treatment (Hot pack for 10 minutes, TENS for 10 minutes, Neck isometrics and stretching
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Numeric Rating Scale
Time Frame: 4 months
|
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.
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4 months
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NECK DISABILITY INDEX
Time Frame: 4 months
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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.
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4 months
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Collaborators and Investigators
Sponsor
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.
- 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.
- Singh LR, Chauhan V. Comparison of efficacy of myofascial release and positional release therapy in tension type headache. JMSCR. 2014;2(9):2372-9.
- Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.
- 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.
- 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.
- 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.
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/Lhr/1062
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
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