Cervicogenic HeadacheNCT05658627
Hamstring Active Release Technique in Cervicogenic Headache
A study testing active release technique and conventional therapy in people with Cervicogenic Headache, run by Cairo University.
Trial summary
It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- active release technique and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jul 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months.
- Pain and tenderness at the upper cervical segment's palpation.
- Movement restriction in cervical region, especially in the upper cervical rotation.
- Positive SLR test for hamstring muscle less than 80◦.
Who cannot join
- Malignancy.
- Other types of headaches, including migraine, tension type, other serious headaches.
- History of head and neck trauma or surgery.
- Pregnancy.
- Physiotherapy for headache in the last 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Hamstring Active Release Technique in Cervicogenic Headache
It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.
Read the detailed description
Cervicogenic Headache (CGH) is a secondary and often unilateral headache that is known by referring pain from soft or hard cervical structures to occipital, temporal and frontal regions. There are some fascial connections between suboccipital muscles with dura mater and C2 vertebra. Presumably, fascial restriction in one part of the body causes unusual stress in other parts of the body due to fascial continuity. It has demonstrated that increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. This occurs because the superficial fascial back line of the myofascial chain connects from the neck to the lower extremity, and the soft tissue in the cervical spine links the dura and suboccipital muscle fascia. Therefore, it is probable that if the tone of the hamstring muscles is decreased (passively, with a fascial treatment or with active movements), the tone of the knee flexors (hamstring muscles) is reduced and the amplitude of hip flexion is increased, thereby increasing the straight leg raise (SLR) test score. Active release technique (ART) is a type of manual therapy used for treating soft tissue injuries. Problems with muscles, tendons, ligaments, fascia and nerves are successfully treated with it and is found to have an effect on hamstring flexibility.
- Conditions
- Cervicogenic Headache
- Being tested
- active release technique, conventional therapy
- Keywords
- active release technique and cervicogenic headache
- 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.
active release techniqueOther
Hamstring active release technique-
conventional therapyOther
ultrasound therapy - stretching Exercise - Strengthening Exercise -
| Study group | Role | What they receive |
|---|---|---|
| 1- control group | Active comparator | conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise) Receives: Other: conventional therapy |
| 2- Experimental group | Experimental | Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise) Receives: Other: active release technique; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change in pain intensity level
The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in rehabilitation.VAS is typically composed of a 100 mm horizontal line attached with two opposed labels, the left end marked "no pain" and the right end "severe intolerable pain".Patients will mark a score on the scale by a vertical line.
Measured: Before treatment and after 4 weeks treatment
Assess the change in headache severity
The headache impact test (HIT-6) : is a tool that subjectively evaluates the frequency of a patient's headache. The lowest score is 36, and the highest score is 78 for six items.Usually, if the score is over 59, it means the patient's daily life is severely affected by the headache.
Measured: Before treatment and after 4 weeks treatment
Assess the change in pressure pain threshold
Pressure algometry will be used to evaluate the (PPT) for suboccipital and hamstring muscles.In the prone position, the physician will apply 1 kg/s of pressure directly to suboccipital and hamstring muscles, the participant will speak up at the point where the pressure evoke a painful sensation, and the instantaneous value will be recorded as the PPT.
Measured: Before treatment and after 4 weeks treatment
Secondary outcomes (2)
Assess the change in Cervical flexion rotation test
By the cervical range of motion (CROM) instrument placed on the head.The evaluator will perform maximum flexion of the cervical spine followed by a rotation to each side.Each measurement will be repeated 3 times at 30 s intervals. The mean value obtained from the 3 trials will be used for data analysis. The reported normal range of rotation during the CFRT is 44° to each side. A test will be reported as positive when individuals demonstrate a reduction of movement of 10◦ compared to the normal range of motion (<34◦).
Measured: Before treatment and after 4 weeks treatment
Assess the change in Hamstrings flexibility
By Straight leg raising test (SLR) to assess Hamstrings flexibility.The participant will be placed in a supine position, his calcaneus will be held with one hand and the leg will be lifted, and the other hand will be fixed so that the patient's knee is not flexed.
Measured: Before treatment and after 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startApr 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed El Sayed Mohammed, Cairo University
- Investigators
- Wadida H Elsayed, Professor, Study chair, Cairo UniversityGhada A Mousa, Ass.prof, Study director, Cairo UniversityHanaa K Atta, Lecturer, Study director, Cairo UniversityNabil H El Agooz, Professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658627
- Sponsor's protocol ID
- P.T.REC/012/003916
- Status last verified
- Apr 2023
- First submitted
- 12 Dec 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
PubMed 25642072
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hamstring Active Release Technique in Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05658627
- Acronym / sponsor ID
- P.T.REC/012/003916
- Conditions
- Cervicogenic Headache
- Keywords
- active release technique and cervicogenic headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 21 Dec 2022 (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.
It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.
Detailed description
Cervicogenic Headache (CGH) is a secondary and often unilateral headache that is known by referring pain from soft or hard cervical structures to occipital, temporal and frontal regions. There are some fascial connections between suboccipital muscles with dura mater and C2 vertebra. Presumably, fascial restriction in one part of the body causes unusual stress in other parts of the body due to fascial continuity. It has demonstrated that increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. This occurs because the superficial fascial back line of the myofascial chain connects from the neck to the lower extremity, and the soft tissue in the cervical spine links the dura and suboccipital muscle fascia. Therefore, it is probable that if the tone of the hamstring muscles is decreased (passively, with a fascial treatment or with active movements), the tone of the knee flexors (hamstring muscles) is reduced and the amplitude of hip flexion is increased, thereby increasing the straight leg raise (SLR) test score. Active release technique (ART) is a type of manual therapy used for treating soft tissue injuries. Problems with muscles, tendons, ligaments, fascia and nerves are successfully treated with it and is found to have an effect on hamstring flexibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- control group | Active comparator | Other: conventional therapyconventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise) |
| 2- Experimental group | Experimental | Other: active release technique, Other: conventional therapyActive release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months.
- Pain and tenderness at the upper cervical segment's palpation.
- Movement restriction in cervical region, especially in the upper cervical rotation.
- Positive SLR test for hamstring muscle less than 80◦.
Key exclusion criteria (5 listed)
- Malignancy.
- Other types of headaches, including migraine, tension type, other serious headaches.
- History of head and neck trauma or surgery.
- Pregnancy.
- Physiotherapy for headache in the last 3 months.
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 |
|---|---|---|
| active release techniqueHamstring active release technique- | Other | 2- Experimental group |
| conventional therapyultrasound therapy - stretching Exercise - Strengthening Exercise - | Other | 1- control group, 2- Experimental group |
Primary outcome
Assess the change in pain intensity level
Time frame: Before treatment and after 4 weeks treatment
The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in rehabilitation.VAS is typically composed of a 100 mm horizontal line attached with two opposed labels, the left end marked "no pain" and the right end "severe intolerable pain".Patients will mark a score on the scale by a vertical line.
Assess the change in headache severity
Time frame: Before treatment and after 4 weeks treatment
The headache impact test (HIT-6) : is a tool that subjectively evaluates the frequency of a patient's headache. The lowest score is 36, and the highest score is 78 for six items.Usually, if the score is over 59, it means the patient's daily life is severely affected by the headache.
Assess the change in pressure pain threshold
Time frame: Before treatment and after 4 weeks treatment
Pressure algometry will be used to evaluate the (PPT) for suboccipital and hamstring muscles.In the prone position, the physician will apply 1 kg/s of pressure directly to suboccipital and hamstring muscles, the participant will speak up at the point where the pressure evoke a painful sensation, and the instantaneous value will be recorded as the PPT.
2 secondary outcomes
Assess the change in Cervical flexion rotation test
Time frame: Before treatment and after 4 weeks treatment
Assess the change in Hamstrings flexibility
Time frame: Before treatment and after 4 weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 25642072Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
- 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.
Wadida H Elsayed, Professor study chair
Cairo University
Ghada A Mousa, Ass.prof study director
Cairo University
Hanaa K Atta, Lecturer study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing active release technique and conventional therapy in people with Cervicogenic Headache, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar A Mohammed, Msc (01275298428, t_nona45@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the change in pain intensity level (time frame: Before treatment and after 4 weeks treatment). The study lists 3 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 NCT05658627, which also lists 1 linked publication.
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 10 Apr 2023.