Cervicogenic HeadacheNCT05754931
Deep Neck Flexors Training Versus Muscle Energy Technique on Cervicogenic Headache
A study testing Deep neck flexors training + Conventional therapy and Muscles energy techniques + conventional therapy in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
Aim of this study is to compare the effects of deep neck flexors stretching versus muscles energy technique on pain, cervical range of motion, sleep disturbance and cervical spine posture in patients with Cervicogenic headache and interpret which technique is better among both.A randomized control trial that will… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Deep neck flexors training + Conventional therapy and Muscles energy techniques + conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Sep 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18 - 55 years.
- Both male and female subjects will be recruited in the study.
- Unilateral headache (without side shift) related by pain, movement and sustaining
- position of neck started from the occiput spread to the tempro-frontal region for more than 3 months
- >20 degree movement restriction in cervical ROM, especially in the upper cervical rotation.
- Positive flexion rotation test to confirm Cervicogenic headache.
- Subjects with rounded shoulders having distance between on the table and the acromion>2.5 cm
Who cannot join
- Fracture or previous surgery on vertebral column
- History of spinal stenosis or disc prolapse
- dysfunction or headache with autonomic involvement
- Other types of headache including migraine, tension type etc.
- laxity of alar ligaments
- vertebra basilar artery insufficiency
- Patients with a history of physiotherapy at least 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Deep Neck Flexors Training Versus Muscle Energy Technique on Cervicogenic Headache
Aim of this study is to compare the effects of deep neck flexors stretching versus muscles energy technique on pain, cervical range of motion, sleep disturbance and cervical spine posture in patients with Cervicogenic headache and interpret which technique is better among both.A randomized control trial that will include total 28 participants.The first group will receive deep neck flexors stretching along with conventional therapy and 2nd group will receive muscles energy technique along with conventional therapy.Data collected will be analyzed through SPSS 25.
Read the detailed description
Cervicogenic headache is a disabling condition associated with musculoskeletal impairment of the cervical region.Cervicogenic headache is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine.Cervicogenic Headache is pain referred to the head from a source in the cervical spine. It can influence the patient's quality of life in addition to a loss of functions when compared with the groups with other headache disorders.
A variety of invasive and noninvasive therapeutic modalities are used in the treatment of cervicogenic headache.Physical therapy is considered as most effective treatment of cervicogenic headache including modalities, manual therapy, muscle stretching, Muscle Energy Techniques, deep neck flexors training, Instrument-Assisted Soft Tissue Mobilization , therapeutic exercises and kinesiology tapping.Deep cervical flexor exercise is a low-load exercise focused on deep cervical flexor muscles, as described by Jull et al. This exercise targets the deep flexor muscles of the cervical region, rather than the superficial flexor muscles. Deep neck flexor training is said to improve the Cervicogenic headache according to the literature review.
According to the Literature review, in cervicogenic headache 2 group of muscles are involved i.e. deep cervical flexors (longus colli, longus capitis, Rectus capitis and Longus capitus) gets weakened and cervical extensors (suboccipital and upper trapezius) gets tightened. It is evident that deep neck flexor training is effective in improving pain, cervical range of motion and posture in Cervicogenic headache. Muscle Energy techniques are also proven to reduce pain and improve range of motion so post isometric relaxation will use in this study. Limited literature is available which compares the effects of post isometric relaxation deep neck flexors and specifically on Cervicogenic headaches. Aim of this study is to compare the effects of these techniques on pain, cervical range of motion, sleep disturbance and cervical spine posture in patients with Cervicogenic headache and interpret which technique is better among both. I hope that this study will add valuable literature and scope for future researchers to work on this topic.
- Conditions
- Cervicogenic Headache
- Being tested
- Deep neck flexors training + Conventional therapy, Muscles energy techniques + conventional therapy
- Keywords
- Cervicogenic Headache, Neck Muscles, exercise muscle stretch, postures
- 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 flexors training + Conventional therapyOther
Hold for 10 sec and repeated 10 times.Patients will be treated 3 times a week for 4 consecutive weeks
Muscles energy techniques + conventional therapyOther
position of patient is in maximal comfort and lengthening After engaging the barrier use of an isometric contraction Feel the release and lengthen the muscle repeated for 4 time per session Patients will be treated 3 times a week for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| deep neck flexor group | Experimental | Deep neck flexors stretch
Conventional Therapy:
Moist heat therapy for 10 minutes, TENS 10 min, cervical active ROMS, Non-thrust mobilizations Receives: Other: Deep neck flexors training + Conventional therapy |
| muscle energy technique | Active comparator | Post isometric stretch on trapezious and suboccipital muscles
Conventional Therapy:
Moist heat therapy for 10 minutes, TENS 10 min, cervical active ROMS, Non-thrust mobilizations Receives: Other: Muscles energy techniques + conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain rating scale
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain.
Measured: 4 weeks
Secondary outcomes (3)
Inclinometer
Measurements of cervical flexion, extension, lateral flexion, and rotation will be measured using inclinometer
Measured: 4 weeks
Cervical posture
For measurement of cervical posture, photographs taken from the side were used for objective measurement of forward head posture
Measured: 4 weeks
Insomnia Severity Index (ISI)
It is a brief self-report questionnaire that measures the patient's perception of insomnia severity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start15 Mar 2023
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha Ali, MSOPMT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754931
- Sponsor's protocol ID
- Hirah Naseem
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Neck Flexors Training Versus Muscle Energy Technique on Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05754931
- Acronym / sponsor ID
- Hirah Naseem
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic Headache, Neck Muscles, exercise muscle stretch, postures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 6 Mar 2023 (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.
Aim of this study is to compare the effects of deep neck flexors stretching versus muscles energy technique on pain, cervical range of motion, sleep disturbance and cervical spine posture in patients with Cervicogenic headache and interpret which technique is better among both.A randomized control trial that will include total 28 participants.The first group will receive deep neck flexors stretching along with conventional therapy and 2nd group will receive muscles energy technique along with conventional therapy.Data collected will be analyzed through SPSS 25.
Detailed description
Cervicogenic headache is a disabling condition associated with musculoskeletal impairment of the cervical region.Cervicogenic headache is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine.Cervicogenic Headache is pain referred to the head from a source in the cervical spine. It can influence the patient's quality of life in addition to a loss of functions when compared with the groups with other headache disorders.
A variety of invasive and noninvasive therapeutic modalities are used in the treatment of cervicogenic headache.Physical therapy is considered as most effective treatment of cervicogenic headache including modalities, manual therapy, muscle stretching, Muscle Energy Techniques, deep neck flexors training, Instrument-Assisted Soft Tissue Mobilization , therapeutic exercises and kinesiology tapping.Deep cervical flexor exercise is a low-load exercise focused on deep cervical flexor muscles, as described by Jull et al. This exercise targets the deep flexor muscles of the cervical region, rather than the superficial flexor muscles. Deep neck flexor training is said to improve the Cervicogenic headache according to the literature review.
According to the Literature review, in cervicogenic headache 2 group of muscles are involved i.e. deep cervical flexors (longus colli, longus capitis, Rectus capitis and Longus capitus) gets weakened and cervical extensors (suboccipital and upper trapezius) gets tightened. It is evident that deep neck flexor training is effective in improving pain, cervical range of motion and posture in Cervicogenic headache. Muscle Energy techniques are also proven to reduce pain and improve range of motion so post isometric relaxation will use in this study. Limited literature is available which compares the effects of post isometric relaxation deep neck flexors and specifically on Cervicogenic headaches. Aim of this study is to compare the effects of these techniques on pain, cervical range of motion, sleep disturbance and cervical spine posture in patients with Cervicogenic headache and interpret which technique is better among both. I hope that this study will add valuable literature and scope for future researchers to work on this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep neck flexor group | Experimental | Other: Deep neck flexors training + Conventional therapyDeep neck flexors stretch Conventional Therapy: Moist heat therapy for 10 minutes, TENS 10 min, cervical active ROMS, Non-thrust mobilizations |
| muscle energy technique | Active comparator | Other: Muscles energy techniques + conventional therapyPost isometric stretch on trapezious and suboccipital muscles Conventional Therapy: Moist heat therapy for 10 minutes, TENS 10 min, cervical active ROMS, Non-thrust mobilizations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects aged 18 - 55 years.
- Both male and female subjects will be recruited in the study.
- Unilateral headache (without side shift) related by pain, movement and sustaining
- position of neck started from the occiput spread to the tempro-frontal region for more than 3 months
- >20 degree movement restriction in cervical ROM, especially in the upper cervical rotation.
Key exclusion criteria (7 listed)
- Fracture or previous surgery on vertebral column
- History of spinal stenosis or disc prolapse
- dysfunction or headache with autonomic involvement
- Other types of headache including migraine, tension type etc.
- laxity of alar ligaments
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 flexors training + Conventional therapyHold for 10 sec and repeated 10 times.Patients will be treated 3 times a week for 4 consecutive weeks | Other | deep neck flexor group |
| Muscles energy techniques + conventional therapyposition of patient is in maximal comfort and lengthening After engaging the barrier use of an isometric contraction Feel the release and lengthen the muscle repeated for 4 time per session Patients will be treated 3 times a week for 4 consecutive weeks | Other | muscle energy technique |
Primary outcome
Numeric Pain rating scale
Time frame: 4 weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain.
3 secondary outcomes
Inclinometer
Time frame: 4 weeks
Cervical posture
Time frame: 4 weeks
Insomnia Severity Index (ISI)
Time frame: 4 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 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cervicogenic Headache
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
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Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
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Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Recruiting
Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
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.
Madiha Ali, MSOPMT 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 flexors training + Conventional therapy and Muscles energy techniques + conventional therapy 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 7 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 13 Mar 2024. 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: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.