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Cervicogenic HeadacheNCT04521218

Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) in Cervicogenic Headache

A study testing Thrust Joint Manipulation and Reverse Sustained Natural apophyseal glides 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

The purpose of the study was to compare the effect of upper cervical thrust joint manipulation and reverse Sustained Natural apophyseal Glide on intensity of pain, pain pressure threshold, range of motion and headache disability in patients with cervicogenic headache. Read more about this study

Who is it for?
Ages 20 to 40 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Thrust Joint Manipulation and Reverse Sustained Natural apophyseal glides
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
4 May 2019to 15 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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Headache frequency of at least 1 per week for a minimum of 3 months
  • Secondary Headache (cervical spine dysfunction)
  • International Classification of headache Disorder:
  • Pain localized in the neck and occiput, which can spread to other areas in the head, such as forehead, orbital region, temples, vertex, or ears, usually unilateral.
  • Pain is precipitated or aggravated by specific neck movements or sustained postures.
  • At least one of the following:
Show all 9Show fewer
  • Resistance to or limitation of passive neck movements
  • Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction
  • Abnormal tenderness of neck musculature

Who cannot join

  • Other types of headache
  • Trigger points of upper cervical muscles
  • Congenital conditions of cervical spine
  • Cervical Disc herniation
  • Fracture
  • Cervical Artery disease
  • Red flags of Thrust Joint Manipulation

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Max health Rehabilitation Centre

    Islamabad, Fedral, 44000

Other trials in Pakistan

About this study

Official title: Comparison of Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) of Upper Cervical Spine in Cervicogenic Headache

The purpose of the study was to compare the effect of upper cervical thrust joint manipulation and reverse Sustained Natural apophyseal Glide on intensity of pain, pain pressure threshold, range of motion and headache disability in patients with cervicogenic headache. A randomized control trial was conducted at Max Rehab and Physical therapy center, Islamabad. The sample size was calculated through open epi tool is 16. The participants were divided in two groups, 8 participants in experimental group and 8 participants in control group. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using sealed envelope method. Only 20 to 40 years participants with cervicogenic headache and associated symptoms were included in the study. Tools used in this study are Numeric pain rating Scale (NPRS), Algometer, Inclinometer and headache disability index (HDI). Data analyzed through Statistical Package for the Social Sciences (SPSS) version 23.

Read the detailed description

In 1983 the term "cervicogenic headache" was introduced in an article in the medical literature. The diagnostic criteria of cervicogenic headache was revised in 1998. The international headache society classified the types of headaches based on their source and characteristics. Studies showed that out of 47% of the patients suffering from headache. 38% are tension-type ; 10% are migraine ; 3% chronic headache and 2.5 to 4.1 % are cervicogenic headaches.The prevalence of cervicogenic headache (CH) after the whiplash is as high as fifty-three percent.Literature revealed that due to varying use of diagnostic measures it is difficult to find out the true prevalence of cervicogenic headache but it ranges from minimum 0.7% to maximum 13.8% in population.

The headache which is originated from the cervical spine and pain is referred to the head region is termed as Cervicogenic headache.So, the source of pain is a cervical region located near the base of the skull, pain is referred from the neck region which travels towards the occulo-frontal and temporal areas of the head.Cervicogenic headache is four times more prevalent in females than males. Females suffer more from cervicogenic head due to hormonal imbalances and poor posture. Poor posture includes the forward headache posture which affects the normal biomechanics of the cervical spine and increases the stress on the neck region.

The possible cause of cervicogenic headache is said to be the supply of the upper three cervical nerves and its various distributions.Upper three cervical nerves innervate the atlantoaxial joint, atlantooccipital joint, facet joint (C2-C3), suboccipital, paravertebral. upper posterior neck musculature, upper cervical ligaments, spinal dura mater, the vertebral artery, intervertebral disc (C2-C3), trapezius, and sternocleidomastoid muscles. Any of these structures is the possible source of pain and it should be diagnosed first. According to the criteria of the International headache society (IHS) impairment in the function of upper cervical muscles is the source of cervicogenic headache.Patients suffering from cervicogenic headaches show a decrease in their quality of life and also compromised physical abilities as compared to other types of headaches.

A multifaced approach is required to treat the patients suffering from cervicogenic headaches. Most commonly pharmacological, non-pharmacological, physical therapy, anesthetic blockade, and sometimes surgical approach is used. A successful intervention requires a multidisciplinary team of physicians including a pain specialist, anesthesiologist, physical therapist, a psychologist to provide a suitable treatment. For the long-lasting effect of the nerve blocks and neurolytic procedures, physical therapy and rehabilitation are required.

Different physical therapy treatments including thrust joint manipulation, mobilizations, exercise program, postural education, or modification used as an effective intervention of cervicogenic headache. A combination of these treatments is used to subside the symptoms of CH.

Literature review:

A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were sustained natural apophyseal glides, thrust joint manipulation, mulligan, and reverse sustained natural apophyseal glides. The purpose of the literature review is to find out the pre-existing literature regarding the Reverse SNAGS and TJM interventions for cervicogenic headache.

According to a systematic review and meta-analysis conducted in 2019 on cervicogenic headache to find out the effectiveness of mobilization and manipulation compared to other conservative interventions in reducing pain and disability. So, it was concluded that both mobilization and manipulation are effective in cervicogenic headache but there were few limitations in the study that only nine studies were included and more quality research are required. Further research is required to observe the long-term effect and other interventions for clinical effectiveness.

An overview of systematic reviews was conducted in 2019 on the physical therapy interventions for cervicogenic headache. Results from the reviews stated that manipulation, mobilization, and other conservative interventions were effective in decreasing the frequency of pain and disability in patients suffering from cervicogenic headaches.

According to a randomized control trial conducted in 2019 on cervicogenic headache. The purpose of the study was to determine the effectiveness of headache sustained natural apophyseal glide (SNAG) and SNAG rotation separately as well as in combination in patients suffering from cervicogenic headache to reduce the headache and improve activity limitation. The results of the study showed that group that received both SNAG and SNAG rotation technique is effective in reducing cervicogenic headache.

A randomized control trail in 2018 on cervicogenic headaches. The purpose of the study was to compare the effectiveness of SNAG and reverse SNAG on patients suffering from cervicogenic headache. Results showed that headache SNAG was more effective than reverse SNAG in treating patients suffering from cervicogenic headache. The major limitation of the study was limited sample size and lack of quantitative equipment for measuring the change.

In recent studies, results reported that Sustained Natural Apophyseal Glides and Thrust Joint Manipulation (TJM) were effective in the management of Cervicogenic Headache. However, they did not report if manipulation resulted in superior outcomes compared to mobilization for the management of this population, or secondly no literature was found regarding the reverse SNAGs as an intervention for cervicogenic headache. The purpose of this study is to compare the effects of reverse SNAG and TJM in patients with cervicogenic headache regarding the improvement of headache, pain, pain pressure threshold, and cervical range of motion

Being tested
Thrust Joint Manipulation, Reverse Sustained Natural apophyseal glides
Keywords
Thrust joint manipulation, Reverse sustained natural apophyseal glides, Cervicogenic headache, Mobilization and Manipulation
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.

  • Thrust Joint ManipulationOther

    Experimental group included TJM, Cervical hot pack, strengthening exercises and home plan; 3 sessions of manipulation per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability.

    These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week.

    Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold.

  • Reverse Sustained Natural apophyseal glidesOther

    Control group included Moist Hot Pack (Cervical contour- 8.25 x 10 x 2) for 10 Mins, Reverse SNAGS (10 Repetitions holding for 10 sec in each glide with a rest time of 30 seconds in between), Strengthening exercise and home plan. 3 sessions of mobilization per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability.

    These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week.

    Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold

Study groups in NCT04521218
Study groupRoleWhat they receive
Thrust joint ManipulationExperimentalThrust joint Manipulation, heat application, Strengthening exercise and home plan
Receives: Other: Thrust Joint Manipulation
Reverse Sustained Natural apophyseal glidesActive comparatorReverse Sustained Natural apophyseal glides (SNAG), heat application, Strengthening exercise and home plan.
Receives: Other: Reverse Sustained Natural apophyseal glides

What is being measured

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

  1. Numeric Pain Rating Scale

    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.

    Measured: 12th Day

Secondary outcomes (6)
  1. Pressure Pain Threshold (PPT)

    Changes from Baseline Pressure Pain Threshold (PPT) were taken with the help of algometer.

    Measured: 12th Day

  2. Headache Disability Index

    Scoring instructions: Yes = 4 points, Sometimes = 2, No = 0. Using this system, a total score of 10-28 is considered to indicate mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability

    Measured: 12th Day

  3. Range of Motion(ROM) Cervical (Flexion)

    Changes from the baseline ROM range of motion of cervical spine flexion was taken with the help of inclinometer

    Measured: 12th Day

  4. ROM Cervical (Extension)

    Changes from the baseline ROM range of motion of cervical spine Extension was taken with the help of inclinometer

    Measured: 12th Day

  5. ROM Cervical (Side Bend)

    Changes from the baseline ROM range of motion of cervical spine Side bending was taken with the help of inclinometer

    Measured: 12th Day

  6. ROM Cervical Rotation

    Changes from the baseline ROM range of motion of cervical spine rotation was taken with the help of inclinometer

    Measured: 12th Day

Timeline

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

  1. First posted20 Aug 2020
  2. Study start4 May 2019
  3. Primary completion15 Dec 2020
  4. Study completion15 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
Model description
Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521218
Sponsor's protocol ID
REC/00694 Amna Arshad
Status last verified
Dec 2020
First submitted
18 Aug 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sjaastad O, Saunte C, Hovdahl H, Breivik H, Gronbaek E. "Cervicogenic" headache. An hypothesis. Cephalalgia. 1983 Dec;3(4):249-56. doi: 10.1046/j.1468-2982.1983.0304249.x. No abstract available.

    PubMed 6640659
  • Sjaastad O, Fredriksen TA, Pfaffenrath V. Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group. Headache. 1998 Jun;38(6):442-5. doi: 10.1046/j.1526-4610.1998.3806442.x. No abstract available.

    PubMed 9664748
  • 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.

    PubMed 14588366
  • Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.

    PubMed 7931379
  • Fleming R, Forsythe S, Cook C. Influential variables associated with outcomes in patients with cervicogenic headache. J Man Manip Ther. 2007;15(3):155-64. doi: 10.1179/106698107790819846.

    PubMed 19066663
  • Evers S. Comparison of cervicogenic headache with migraine. Cephalalgia. 2008 Jul;28 Suppl 1:16-7. doi: 10.1111/j.1468-2982.2008.01609.x. No abstract available.

    PubMed 18494987
  • Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.

    PubMed 19747657
  • van Suijlekom JA, Weber WE, van Kleef M. Cervicogenic headache: techniques of diagnostic nerve blocks. Clin Exp Rheumatol. 2000 Mar-Apr;18(2 Suppl 19):S39-44.

    PubMed 10824286
  • Biondi DM. Cervicogenic headache: diagnostic evaluation and treatment strategies. Curr Pain Headache Rep. 2001 Aug;5(4):361-8. doi: 10.1007/s11916-001-0026-x.

    PubMed 11403740
  • Bogduk N. The neck and headaches. Neurol Clin. 2004 Feb;22(1):151-71, vii. doi: 10.1016/S0733-8619(03)00100-2.

    PubMed 15062532
  • Jull G, Barrett C, Magee R, Ho P. Further clinical clarification of the muscle dysfunction in cervical headache. Cephalalgia. 1999 Apr;19(3):179-85. doi: 10.1046/j.1468-2982.1999.1903179.x.

    PubMed 10234466
  • Mohamed AA, Shendy WS, Semary M, Mourad HS, Battecha KH, Soliman ES, Sayed SHE, Mohamed GI. Combined use of cervical headache snag and cervical snag half rotation techniques in the treatment of cervicogenic headache. J Phys Ther Sci. 2019 Apr;31(4):376-381. doi: 10.1589/jpts.31.376. Epub 2019 Apr 1.

    PubMed 31037013
  • Umar M, Naeem A, Badshah M, Zaidi S. A randomized control trial to review the effectiveness of cervical mobilization combined with stretching exercises in cervicogenic headache. J Public Health Biolo Sci. 2012;1(1):09-13.

  • Jamil M, Janjua U. Comparison of cervicogenic headache between housewives and working women. Rawal Medical Journal. 2020 Jan;45(1):77-9.

  • Umar M, Badshah M, Maryam M, Naeem A, Rehman L, Ahmed M. Prevalence Of Different Types Of Headache In Medical Students Of Rawalpindi & Islamabad. International Journal of Rehabilitation Sciences (IJRS). 2018 Mar 15;4(01):15-9.

Questions about this trial

What is this clinical trial studying?

A study testing Thrust Joint Manipulation and Reverse Sustained Natural apophyseal glides 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 9 inclusion and 7 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 17 Dec 2020. 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?

Numeric Pain Rating Scale (time frame: 12th Day). 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 NCT04521218, which also lists 18 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 17 Dec 2020.

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Clinical Trial NCT04521218 | AzTrials