- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658627
Hamstring Active Release Technique in Cervicogenic Headache
April 7, 2023 updated by: Samar Ahmed El Sayed Mohammed, Cairo University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samar A Mohammed, Msc
- Phone Number: 01275298428
- Email: t_nona45@yahoo.com
Study Contact Backup
- Name: Wadida H Elsayed, Professor
- Phone Number: 01001097571
- Email: dr.wadida.hassan@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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◦.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1- control group
conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise)
|
ultrasound therapy - stretching Exercise - Strengthening Exercise -
|
|
Experimental: 2- Experimental group
Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise)
|
ultrasound therapy - stretching Exercise - Strengthening Exercise -
Hamstring active release technique-
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before treatment and after 4 weeks treatment
|
|
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.
|
Before treatment and after 4 weeks treatment
|
|
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.
|
Before treatment and after 4 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the change in Cervical flexion rotation test
Time Frame: Before treatment and after 4 weeks treatment
|
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◦).
|
Before treatment and after 4 weeks treatment
|
|
Assess the change in Hamstrings flexibility
Time Frame: Before treatment and after 4 weeks treatment
|
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.
|
Before treatment and after 4 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wadida H Elsayed, Professor, Cairo University
- Study Director: Ghada A Mousa, Ass.prof, Cairo University
- Study Director: Hanaa K Atta, Lecturer, Cairo University
- Study Director: Nabil H El Agooz, Professor, Al-Azhar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
December 12, 2022
First Submitted That Met QC Criteria
December 20, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003916
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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