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Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache (IASTM)

Primary Purpose

Cervicogenic Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
instrumented assisted soft tissue mobilization
traditional 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 instrumented assisted soft tissue mobilization, cervicogenic headache, proprioception

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 35 to 50 years old
  • unilaterality of the head pain
  • pain triggered by external pressure over the upper cervical joints (C1-C3)
  • pain elicited by the neck movements, and/or sustained awkward positions, reduced neck ROM
  • headache intensity pain score of at least 20mm on the Visual Analogue Scale,
  • headache frequency of at least once a week for at least 3 months
  • minimum neck disability index score of 10 points or greater.

Exclusion Criteria:

  • migraine
  • tension-type headache
  • tumor
  • osteoporosis
  • fracture
  • rheumatoid arthritis and metabolic diseases
  • prolonged history of steroid use
  • resting blood pressure greater than 140/90 mmHg
  • cervical spinal stenosis
  • diminished sensation
  • central nervous system involvement
  • previous head or neck surgery
  • whiplash injury history within the last 6 weeks
  • head or neck pain treatment within the last month from any practitioner and PT approach for head or neck pain within the last 3 months
  • open wounds and psychiatric/cognitive disorders
  • patients contraindicated to carotid artery massage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    instrumented assisted soft tissue mobilization

    traditional therapy

    Arm Description

    patients will receive IASTM three times a week for eight weeks

    patients will receive traditional therapy three times a week for eight weeks

    Outcomes

    Primary Outcome Measures

    joint position error
    The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).

    Secondary Outcome Measures

    disability
    The neck disability index (NDI) will be used for measuring neck disability and it is a self-patient-completed questionnaire that measures patients' functional status. It contains 10 questions regarding pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six answer choices scored from 0 to 5 as 0 indicates no disability and 5 indicates complete disability. All sections are scored then totaled on a scale from 0 to 50, as zero is the best possible score and 50 is the worst one
    headache frequency
    the number of days the patients feel headache
    headache duration
    the total hour of headache
    medication intake
    from the patient diary in the last week, medication intake will be recorded as follow: 1) not at all; 2) once a week; 3) once every couple of days; 4) once or twice a day; or 5) three or more times a day.
    pain intensity
    Visual Analogue Scale which is a 100-mm horizontal line will be used for measuring pain intensity. The patients will be instructed to represent their pain intensity level by marking anywhere on the line with "no pain" on the left side and "worst pain" on the right side.
    forward head posture
    cervical range of motion 2 (CROM2 ruler will be used for assess the forward head posture
    rounded shoulder assessment
    tape measurement will be used to to assess rounded shoulder: Subjects will be requested to stand normally with their hands hanging beside their bodies to test for rounded shoulder posture. Then, sternal notch, coracoid process, posteriolateral angle of the acromion process and the adjacent thoracic spinous process will be palpated and marked. The distance between sternal notch and coracoid process, and the distance between the posterolateral angle of the acromion process and the adjacent thoracic spinous process will measured by using tape.
    suboccipital flexion and extension of cervical vertebra
    The cervical range of motion device (CROM) will measure suboccipital flexion and extension of cervical vertebrae. Instruct the subject to position the CROM Instrument as if putting on a pair of glasses. Fasten the velcro strap in line with the bows. Instruct the subject to stand facing away from an outside corner of a wall or edge of an open door frame. The subject's sacrum, thoracic spine, and occiput must be in contact with the corner of the wall or door edge. Instruct the subject to flex the suboccipital area as much as possible while maintaining equal pressure on the skull, thorax, and sacrum. Record this measurement. Instruct the subject to extend the suboccipital area as much as possible without allowing the skull, thorax, and sacrum to leave the contact surface.
    headache disability
    headache-specific disability questionnaire will be used to assess headache disability. the questionnaire has 9 items. the score for each one from 0 to 10. a score of 10-28% is considered to constitute mild disability; 30-48% is moderate; 50-68% is severe; 72% or more is complete.

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 16, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05545423
    Brief Title
    Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache
    Acronym
    IASTM
    Official Title
    Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache: A Parallel Group, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2023 (Anticipated)
    Study Completion Date
    March 30, 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

    5. Study Description

    Brief Summary
    This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.
    Detailed Description
    The International Headache Society has classified the cervicogenic headache as a secondary headache type that is hypothesized to originate due to nociception in the cervical area. The main difference between these patients with and without cervicogenic headache is the lateralization of pressure hyperalgesia to the painful side of the head and neck, there is a unilateral pattern of pressure hyperalgesia in the head and neck that typifies the altered sensory processing in patients with cervicogenic headache. Cervicogenic headache pain has been mostly related to joint, disc and ligament disease of the upper cervical spine. However, the upper cervical nerves also receive afferent inputs from the muscle tissues. Several physical therapy techniques are proposed for this type of headache. Strength and endurance exercises, when accompanied by stretching exercises, were shown to be an effective treatment for cervicogenic headache patients. The lack of solid evidence of positive effects and risks of serious complications for spinal manipulation should be considered in favor of other physical therapy options associated with less risk. Graston Technique is an instrument assisted soft tissue mobilization (IASTM) treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. It thus creates an inflammatory response to accelerate the healing process and restore flexible, normal tissue. This technique seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis. eighty patients with carcinogenic headache will be allocated randomly to two equal group. one group will receive IASTM and traditional therapy and other will receive traditional only for eight weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervicogenic Headache
    Keywords
    instrumented assisted soft tissue mobilization, cervicogenic headache, proprioception

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    instrument-assisted soft tissue mobilization and traditional therapy
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    instrumented assisted soft tissue mobilization
    Arm Type
    Experimental
    Arm Description
    patients will receive IASTM three times a week for eight weeks
    Arm Title
    traditional therapy
    Arm Type
    Active Comparator
    Arm Description
    patients will receive traditional therapy three times a week for eight weeks
    Intervention Type
    Other
    Intervention Name(s)
    instrumented assisted soft tissue mobilization
    Intervention Description
    the appropriate Graston technique instrument will be selected to scan, and then treat the affected area for 30 to 60 seconds per treated area. The procedure will be applied to the superficial cervical fascia and invested the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sternocleidomastoids and upper fibers of trapezius muscles. The IASTM technique was applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, following immediately by an additional 20-seconds application at a 45° angle in a perpendicular direction to the muscle fibers, resulting in a total treatment time of approximately 40 seconds.
    Intervention Type
    Other
    Intervention Name(s)
    traditional therapy
    Intervention Description
    The exercise program will be in the form of stretching exercises for the sternocleidomastoids (SCM), the scalenes, and upper fibers of trapezius; strengthening isometric exercises for the neck flexors, extensors, lateral flexors, and neck rotators; and postural correction and scapular stabilization exercises
    Primary Outcome Measure Information:
    Title
    joint position error
    Description
    The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).
    Time Frame
    up to eight weeks
    Secondary Outcome Measure Information:
    Title
    disability
    Description
    The neck disability index (NDI) will be used for measuring neck disability and it is a self-patient-completed questionnaire that measures patients' functional status. It contains 10 questions regarding pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six answer choices scored from 0 to 5 as 0 indicates no disability and 5 indicates complete disability. All sections are scored then totaled on a scale from 0 to 50, as zero is the best possible score and 50 is the worst one
    Time Frame
    up to eight weeks
    Title
    headache frequency
    Description
    the number of days the patients feel headache
    Time Frame
    up to eight weeks
    Title
    headache duration
    Description
    the total hour of headache
    Time Frame
    up to eight weeks
    Title
    medication intake
    Description
    from the patient diary in the last week, medication intake will be recorded as follow: 1) not at all; 2) once a week; 3) once every couple of days; 4) once or twice a day; or 5) three or more times a day.
    Time Frame
    up to eight weeks
    Title
    pain intensity
    Description
    Visual Analogue Scale which is a 100-mm horizontal line will be used for measuring pain intensity. The patients will be instructed to represent their pain intensity level by marking anywhere on the line with "no pain" on the left side and "worst pain" on the right side.
    Time Frame
    up to eight weeks
    Title
    forward head posture
    Description
    cervical range of motion 2 (CROM2 ruler will be used for assess the forward head posture
    Time Frame
    up to eight weeks
    Title
    rounded shoulder assessment
    Description
    tape measurement will be used to to assess rounded shoulder: Subjects will be requested to stand normally with their hands hanging beside their bodies to test for rounded shoulder posture. Then, sternal notch, coracoid process, posteriolateral angle of the acromion process and the adjacent thoracic spinous process will be palpated and marked. The distance between sternal notch and coracoid process, and the distance between the posterolateral angle of the acromion process and the adjacent thoracic spinous process will measured by using tape.
    Time Frame
    up to eight weeks
    Title
    suboccipital flexion and extension of cervical vertebra
    Description
    The cervical range of motion device (CROM) will measure suboccipital flexion and extension of cervical vertebrae. Instruct the subject to position the CROM Instrument as if putting on a pair of glasses. Fasten the velcro strap in line with the bows. Instruct the subject to stand facing away from an outside corner of a wall or edge of an open door frame. The subject's sacrum, thoracic spine, and occiput must be in contact with the corner of the wall or door edge. Instruct the subject to flex the suboccipital area as much as possible while maintaining equal pressure on the skull, thorax, and sacrum. Record this measurement. Instruct the subject to extend the suboccipital area as much as possible without allowing the skull, thorax, and sacrum to leave the contact surface.
    Time Frame
    up to eight weeks
    Title
    headache disability
    Description
    headache-specific disability questionnaire will be used to assess headache disability. the questionnaire has 9 items. the score for each one from 0 to 10. a score of 10-28% is considered to constitute mild disability; 30-48% is moderate; 50-68% is severe; 72% or more is complete.
    Time Frame
    up to eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 35 to 50 years old unilaterality of the head pain pain triggered by external pressure over the upper cervical joints (C1-C3) pain elicited by the neck movements, and/or sustained awkward positions, reduced neck ROM headache intensity pain score of at least 20mm on the Visual Analogue Scale, headache frequency of at least once a week for at least 3 months minimum neck disability index score of 10 points or greater. Exclusion Criteria: migraine tension-type headache tumor osteoporosis fracture rheumatoid arthritis and metabolic diseases prolonged history of steroid use resting blood pressure greater than 140/90 mmHg cervical spinal stenosis diminished sensation central nervous system involvement previous head or neck surgery whiplash injury history within the last 6 weeks head or neck pain treatment within the last month from any practitioner and PT approach for head or neck pain within the last 3 months open wounds and psychiatric/cognitive disorders patients contraindicated to carotid artery massage

    12. IPD Sharing Statement

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    Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache

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