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Hamstring Active Release Technique in Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active release technique
conventional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring active release technique and cervicogenic headache

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1- control group

    2- Experimental group

    Arm Description

    conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise)

    Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise)

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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◦).
    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.

    Full Information

    First Posted
    December 12, 2022
    Last Updated
    April 7, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05658627
    Brief Title
    Hamstring Active Release Technique in Cervicogenic Headache
    Official Title
    Effect of Hamstring Active Release Technique in Cervicogenic Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervicogenic Headache
    Keywords
    active release technique and cervicogenic headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1- control group
    Arm Type
    Active Comparator
    Arm Description
    conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise)
    Arm Title
    2- Experimental group
    Arm Type
    Experimental
    Arm Description
    Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise)
    Intervention Type
    Other
    Intervention Name(s)
    active release technique
    Intervention Description
    Hamstring active release technique-
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Intervention Description
    ultrasound therapy - stretching Exercise - Strengthening Exercise -
    Primary Outcome Measure Information:
    Title
    Assess the change in pain intensity level
    Description
    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.
    Time Frame
    Before treatment and after 4 weeks treatment
    Title
    Assess the change in headache severity
    Description
    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.
    Time Frame
    Before treatment and after 4 weeks treatment
    Title
    Assess the change in pressure pain threshold
    Description
    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.
    Time Frame
    Before treatment and after 4 weeks treatment
    Secondary Outcome Measure Information:
    Title
    Assess the change in Cervical flexion rotation test
    Description
    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◦).
    Time Frame
    Before treatment and after 4 weeks treatment
    Title
    Assess the change in Hamstrings flexibility
    Description
    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.
    Time Frame
    Before treatment and after 4 weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samar A Mohammed, Msc
    Phone
    01275298428
    Email
    t_nona45@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wadida H Elsayed, Professor
    Phone
    01001097571
    Email
    dr.wadida.hassan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wadida H Elsayed, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ghada A Mousa, Ass.prof
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hanaa K Atta, Lecturer
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nabil H El Agooz, Professor
    Organizational Affiliation
    Al-Azhar University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25642072
    Citation
    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.
    Results Reference
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    Hamstring Active Release Technique in Cervicogenic Headache

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