Cervicogenic HeadacheNCT04954716
Manual Techniques in Cervicogenic Headache
A study testing Deep Neck Flexor Massage and Post-Isometric Relaxation Technique in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project will explore the effect of deep friction massage and post isometric relaxation techniques in Cervicogenic headache. The population sample will be 20 divided randomly into two groups by Lottery method. Then i will collect data from central hospital, Gujranwala. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Deep Neck Flexor Massage and Post-Isometric Relaxation Technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 10 Aug 2021
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Symptoms duration more than 6 months.
- Age 18 -60
- Patient has confirmed the diagnosis of cervicogenic headache
Who cannot join
- Rule out cervical malignancy
- infection (such as osteomyelitis or diskitis)
- osteoporosis, inflammatory arthritis.
- fracture, pregnancy
- cord compression, uncontrolled hypertension
- cardiovascular disease
- in the setting of carotid or vertebral artery disease.
- Trauma cases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Central hospital Gujranwala
Guiranwala, Punjab Province, 54560
About this study
Official title: Comparison of Deep Friction Massage and Post Isometric Relaxation Technique in Cervicogenic Headache
This project will explore the effect of deep friction massage and post isometric relaxation techniques in Cervicogenic headache. The population sample will be 20 divided randomly into two groups by Lottery method. Then i will collect data from central hospital, Gujranwala. One group will be treated with a deep friction massage technique thrice a week for 3 weeks. Another group will be treated with a post isometric relaxation technique thrice a week for 3 weeks. Both groups will receive a heating pad and neck isometric as baseline treatment. Baseline measurements are taken by an inclinometer. After a treatment plan, the group will be assessed again and post-treatment measured values will be compared with the pretest values. Subjects will be asked to come for follow-up after 4 weeks. The follow-up will show which technique is more effective in subjects having Cervicogenic headaches. Both the techniques used are non-invasive and having minimum side effects. This project will help Physical Therapy Practitioner to explore which technique is more useful to treat Cervicogenic headaches.
Read the detailed description
Cervicogenic headache is a relatively common and still controversial form of headache arising from structures in the neck. In patients with this disorder, attacks or chronic fluctuating periods of neck/head pain may be provoked by the sustained neck. The International Headache Society (IHS), 2013 defined Cervicogenic Headache (CGH) as a secondary headache, which implies that headache is caused by a disorder of the cervical spine and its components bony, disc, and soft tissue elements. CGH can be a perplexing pain disorder that is refractory to treatment if it is perceived. Patients with CGH exhibited decreases in the quality of life comparable to migraine patients and patients with tension-type headaches, with even lower scores for physical functioning.
.Headache is a common disorder affecting up to 66% of the general population. headache negatively influences both quality of life and labor productivity.Cervicogenic headache is one of the common types of headache accounting for 0.4-15% of the headache population.
we distinguished it from other types of headaches, such as a migraine, that may present with some common symptoms. The International Headache Society (IHS) classified CGH as a secondary headache arising from musculoskeletal disorders in the cervical spine. The complicated convergence of cervical afferents with trigeminal afferents in the trigemino-cervical complex is intended as the physiologic basis of a headache arising from cervical structures.
The aim of friction massage is to take care of the quality at intervals the soft tissue structures of ligament, tendon, and muscle and stop adherent scars from forming. The massage is deep and should be applied transversally to the precise tissue concerned in contrast to the superficial massage given within the longitudinal direction parallel to the vessels which boosts circulation and come of fluid. Profound cervical flexor (DCF) has a noteworthy postural capacity in supporting and rectifying the cervical lordosis. It has been discovered that specific muscles in the cervical spine have a tendency to debilitate , the most widely recognized of these being the DCF.
MET is a treatment technique that includes a willful constriction of a subject's muscle in a correctly controlled bearing, against a counterforce that is given by the specialist. MET is utilized to diminish the pain, extend the tight muscles and belts, decrease muscle tone, enhances nearby flow, strengthen the feeble musculature, and mobilizes the joint restrictions. MET increases the extensibility of muscles and spinal range of motion, treating patients with reduced mobility. Extending includes the use of manual or mechanical power to prolong/protract the structures that are adaptively been abbreviated and are hypomobile.
Post-isometric relaxation (PIR) may be a technique typically employed by manual therapists for treating muscle tension and joint pathology in myofascial pain syndromes There is a lack of evidence demonstrating the efficacy of deep friction massage therapy in the management of cervicogenic headache, particularly targeting cervical muscle tightness related to Cervicogenic headache. The purpose of this study is to compare the effect of soft tissue massage with MET to access which technique has a greater clinical impact than others in improving cervicogenic headache.
- Conditions
- Cervicogenic Headache
- Being tested
- Deep Neck Flexor Massage, Post-Isometric Relaxation Technique
- Keywords
- Cervicogenic headache (CH, CGH), Muscle Energy Technique (MET), ,Post-isometric relaxation(PIR)
- 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.
Deep Neck Flexor MassageOther
Deep friction massage is a specific connective tissue massage that was given across the affected fibers.The therapist's fingers and patient's skin must move as one, otherwise moving subcutaneous fascia against muscle or ligament could lead to blister formation or subcutaneous bruising.The friction massage must have sufficient sweep and be deep enough.
Post-Isometric Relaxation TechniqueOther
The PIR technique is performed as follows.The hypertonic muscle is taken to a length just short of pain, or to the point where resistance to movement is first noted.A submaximal (10-20%) contraction of the hypertonic muscle is performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction . The patient should inhale during this effort.After the isometric contraction the patient is asked to relax and exhale while doing so.Following this a gentle stretch is applied to take up the slack till the new barrier.Starting from this new barrier, the procedure is repeated two or three times.
| Study group | Role | What they receive |
|---|---|---|
| Deep Neck Flexor Massage | Experimental | INTERVENTIONAL GROUP(DEEP Neck FLEXOR MASSAGE) Receives: Other: Deep Neck Flexor Massage |
| Post-Isometric Relaxation Technique | Active comparator | CONTROL GROUP (POST-ISOMETRIC RELAXATION TECHNIQUE) Receives: Other: Post-Isometric Relaxation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache disability index
This scale is used to identify difficulties that you may be experiencing because of your headache. Please check off "YES", "SOMETIMES", or "NO" to each item. Proforma consist of 25 question
Scoring The following responses are given the following values:
Response Points Yes 4 Sometimes 2 No 0 Interpretation A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.
Measured: 3 week
Secondary outcomes (1)
Upper cervical spine(ROM)
standard technique for measuring cervical spine motions in different rotations, including sagittal, frontal, transversal, and rotational
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Jan 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sana ullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954716
- Sponsor's protocol ID
- REC/Lhr/20/0111/Bushra
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martelletti P, van Suijlekom H. Cervicogenic headache: practical approaches to therapy. CNS Drugs. 2004;18(12):793-805. doi: 10.2165/00023210-200418120-00004.
PubMed 15377169Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
PubMed 17381554Castien RF, De Hertogh W, Scholten-Peeters GG. Letter to the Editor: Physical examination tests for screening and diagnosis of cervicogenic headache: A systematic review by Rubio-Ochoa et al. (2015). Man Ther. 2016 Jun;23:e7-8. doi: 10.1016/j.math.2016.01.006. Epub 2016 Jan 29. No abstract available.
PubMed 26934859Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Spinal manipulative therapy in the management of cervicogenic headache. Headache. 2005 Oct;45(9):1260-3. doi: 10.1111/j.1526-4610.2005.00253_1.x.
PubMed 16178960Garcia JD, Arnold S, Tetley K, Voight K, Frank RA. Mobilization and Manipulation of the Cervical Spine in Patients with Cervicogenic Headache: Any Scientific Evidence? Front Neurol. 2016 Mar 21;7:40. doi: 10.3389/fneur.2016.00040. eCollection 2016.
PubMed 27047446Bogduk 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 11403743Li L, Stoop R, Clijsen R, Hohenauer E, Fernandez-de-Las-Penas C, Huang Q, Barbero M. Criteria Used for the Diagnosis of Myofascial Trigger Points in Clinical Trials on Physical Therapy: Updated Systematic Review. Clin J Pain. 2020 Dec;36(12):955-967. doi: 10.1097/AJP.0000000000000875.
PubMed 32841969Chamberlain GJ. Cyriax's Friction Massage: A Review. J Orthop Sports Phys Ther. 1982;4(1):16-22. doi: 10.2519/jospt.1982.4.1.16.
PubMed 18810110Emary P. Use of post-isometric relaxation in the chiropractic management of a 55-year-old man with cervical radiculopathy. J Can Chiropr Assoc. 2012 Mar;56(1):9-17.
PubMed 22457537Youssef EF, Shanb AS. Mobilization versus massage therapy in the treatment of cervicogenic headache: a clinical study. J Back Musculoskelet Rehabil. 2013;26(1):17-24. doi: 10.3233/BMR-2012-0344.
PubMed 23411644Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
PubMed 22460941
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Friction Massage and Post Isometric Relaxation Technique in Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT04954716
- Acronym / sponsor ID
- REC/Lhr/20/0111/Bushra
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic headache (CH, CGH), Muscle Energy Technique (MET), ,Post-isometric relaxation(PIR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will explore the effect of deep friction massage and post isometric relaxation techniques in Cervicogenic headache. The population sample will be 20 divided randomly into two groups by Lottery method. Then i will collect data from central hospital, Gujranwala. One group will be treated with a deep friction massage technique thrice a week for 3 weeks. Another group will be treated with a post isometric relaxation technique thrice a week for 3 weeks. Both groups will receive a heating pad and neck isometric as baseline treatment. Baseline measurements are taken by an inclinometer. After a treatment plan, the group will be assessed again and post-treatment measured values will be compared with the pretest values. Subjects will be asked to come for follow-up after 4 weeks. The follow-up will show which technique is more effective in subjects having Cervicogenic headaches. Both the techniques used are non-invasive and having minimum side effects. This project will help Physical Therapy Practitioner to explore which technique is more useful to treat Cervicogenic headaches.
Detailed description
Cervicogenic headache is a relatively common and still controversial form of headache arising from structures in the neck. In patients with this disorder, attacks or chronic fluctuating periods of neck/head pain may be provoked by the sustained neck. The International Headache Society (IHS), 2013 defined Cervicogenic Headache (CGH) as a secondary headache, which implies that headache is caused by a disorder of the cervical spine and its components bony, disc, and soft tissue elements. CGH can be a perplexing pain disorder that is refractory to treatment if it is perceived. Patients with CGH exhibited decreases in the quality of life comparable to migraine patients and patients with tension-type headaches, with even lower scores for physical functioning.
.Headache is a common disorder affecting up to 66% of the general population. headache negatively influences both quality of life and labor productivity.Cervicogenic headache is one of the common types of headache accounting for 0.4-15% of the headache population.
we distinguished it from other types of headaches, such as a migraine, that may present with some common symptoms. The International Headache Society (IHS) classified CGH as a secondary headache arising from musculoskeletal disorders in the cervical spine. The complicated convergence of cervical afferents with trigeminal afferents in the trigemino-cervical complex is intended as the physiologic basis of a headache arising from cervical structures.
The aim of friction massage is to take care of the quality at intervals the soft tissue structures of ligament, tendon, and muscle and stop adherent scars from forming. The massage is deep and should be applied transversally to the precise tissue concerned in contrast to the superficial massage given within the longitudinal direction parallel to the vessels which boosts circulation and come of fluid. Profound cervical flexor (DCF) has a noteworthy postural capacity in supporting and rectifying the cervical lordosis. It has been discovered that specific muscles in the cervical spine have a tendency to debilitate , the most widely recognized of these being the DCF.
MET is a treatment technique that includes a willful constriction of a subject's muscle in a correctly controlled bearing, against a counterforce that is given by the specialist. MET is utilized to diminish the pain, extend the tight muscles and belts, decrease muscle tone, enhances nearby flow, strengthen the feeble musculature, and mobilizes the joint restrictions. MET increases the extensibility of muscles and spinal range of motion, treating patients with reduced mobility. Extending includes the use of manual or mechanical power to prolong/protract the structures that are adaptively been abbreviated and are hypomobile.
Post-isometric relaxation (PIR) may be a technique typically employed by manual therapists for treating muscle tension and joint pathology in myofascial pain syndromes There is a lack of evidence demonstrating the efficacy of deep friction massage therapy in the management of cervicogenic headache, particularly targeting cervical muscle tightness related to Cervicogenic headache. The purpose of this study is to compare the effect of soft tissue massage with MET to access which technique has a greater clinical impact than others in improving cervicogenic headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Neck Flexor Massage | Experimental | Other: Deep Neck Flexor MassageINTERVENTIONAL GROUP(DEEP Neck FLEXOR MASSAGE) |
| Post-Isometric Relaxation Technique | Active comparator | Other: Post-Isometric Relaxation TechniqueCONTROL GROUP (POST-ISOMETRIC RELAXATION TECHNIQUE) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders.
- Symptoms duration more than 6 months.
- Age 18 -60
- Patient has confirmed the diagnosis of cervicogenic headache
Key exclusion criteria (8 listed)
- Rule out cervical malignancy
- infection (such as osteomyelitis or diskitis)
- osteoporosis, inflammatory arthritis.
- fracture, pregnancy
- cord compression, uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Neck Flexor MassageDeep friction massage is a specific connective tissue massage that was given across the affected fibers.The therapist's fingers and patient's skin must move as one, otherwise moving subcutaneous fascia against muscle or ligament could lead to blister formation or subcutaneous bruising.The friction massage must have sufficient sweep and be deep enough. | Other | Deep Neck Flexor Massage |
| Post-Isometric Relaxation TechniqueThe PIR technique is performed as follows.The hypertonic muscle is taken to a length just short of pain, or to the point where resistance to movement is first noted.A submaximal (10-20%) contraction of the hypertonic muscle is performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction . The patient should inhale during this effort.After the isometric contraction the patient is asked to relax and exhale while doing so.Following this a gentle stretch is applied to take up the slack till the new barrier.Starting from this new barrier, the procedure is repeated two or three times. | Other | Post-Isometric Relaxation Technique |
Primary outcome
Headache disability index
Time frame: 3 week
This scale is used to identify difficulties that you may be experiencing because of your headache. Please check off "YES", "SOMETIMES", or "NO" to each item. Proforma consist of 25 question Scoring The following responses are given the following values: Response Points Yes 4 Sometimes 2 No 0 Interpretation A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.
1 secondary outcome
Upper cervical spine(ROM)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 15377169Martelletti P, van Suijlekom H. Cervicogenic headache: practical approaches to therapy. CNS Drugs. 2004;18(12):793-805. doi: 10.2165/00023210-200418120-00004.
- Background: PubMed 17381554Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
- Background: PubMed 26934859Castien RF, De Hertogh W, Scholten-Peeters GG. Letter to the Editor: Physical examination tests for screening and diagnosis of cervicogenic headache: A systematic review by Rubio-Ochoa et al. (2015). Man Ther. 2016 Jun;23:e7-8. doi: 10.1016/j.math.2016.01.006. Epub 2016 Jan 29. No abstract available.
- Background: PubMed 16178960Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Spinal manipulative therapy in the management of cervicogenic headache. Headache. 2005 Oct;45(9):1260-3. doi: 10.1111/j.1526-4610.2005.00253_1.x.
- Background: PubMed 27047446Garcia JD, Arnold S, Tetley K, Voight K, Frank RA. Mobilization and Manipulation of the Cervical Spine in Patients with Cervicogenic Headache: Any Scientific Evidence? Front Neurol. 2016 Mar 21;7:40. doi: 10.3389/fneur.2016.00040. eCollection 2016.
- Background: PubMed 11403743Bogduk 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.
- Background: PubMed 32841969Li L, Stoop R, Clijsen R, Hohenauer E, Fernandez-de-Las-Penas C, Huang Q, Barbero M. Criteria Used for the Diagnosis of Myofascial Trigger Points in Clinical Trials on Physical Therapy: Updated Systematic Review. Clin J Pain. 2020 Dec;36(12):955-967. doi: 10.1097/AJP.0000000000000875.
- Background: PubMed 18810110Chamberlain GJ. Cyriax's Friction Massage: A Review. J Orthop Sports Phys Ther. 1982;4(1):16-22. doi: 10.2519/jospt.1982.4.1.16.
- Background: PubMed 22457537Emary P. Use of post-isometric relaxation in the chiropractic management of a 55-year-old man with cervical radiculopathy. J Can Chiropr Assoc. 2012 Mar;56(1):9-17.
- Background: PubMed 23411644Youssef EF, Shanb AS. Mobilization versus massage therapy in the treatment of cervicogenic headache: a clinical study. J Back Musculoskelet Rehabil. 2013;26(1):17-24. doi: 10.3233/BMR-2012-0344.
- Background: PubMed 22460941Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Sana ullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Neck Flexor Massage and Post-Isometric Relaxation Technique 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 4 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 24 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?
Headache disability index (time frame: 3 week). 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 NCT04954716, which also lists 11 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 24 Aug 2021.