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Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache (DN)

Primary Purpose

Cervicogenic Headache

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

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 to 60 years old patient with unilaterally 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 with reduced neck ROM
  • headache intensity pain score of at least 20mm on the Visual analogue scale (VAS)
  • 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 and central nervous system involvement,
  • previous head or neck surgery or whiplash injury history within the last 6 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    dry needling

    instrumented assisted soft tissue mobilization

    conventional therapy

    Arm Description

    the patient will receive dry needling and conventional therapy three times per week for four weeks

    the patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks

    the patient will receive conventional therapy three times per week for four weeks

    Outcomes

    Primary Outcome Measures

    pain intensity
    visual analogue scale will be used to asses pain intensity which patient will be instructed to put point on line from no pain to tolerable pain. The scale consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel .
    neck disability
    will be measured by Arabic neck disability index. It contains ten category/classes. Each category contains six choices (zero-five).Score from zero to four no disability, from five to 15 this is mild, From 15 to 24 this is moderate, from 25 to 34 this is severe, more than 34 this is a complete disability
    pressure pain threshold
    pressure pain threshold will be assessed by commander algometer

    Secondary Outcome Measures

    range of motion
    range of motion will be measured by inclinometer CROM. The CROM (deluxe version - Performance Attainment Associates, Roseville, MN, USA) measures the cervical range of motion5- for flexion, extension, lateral flexion, and rotation using separate inclinometers. These inclinometers are attached to a frame similar to that for eyeglasses one in the sagittal plane for flexion - extension, second in the frontal plane for lateral flexion and a third in the horizontal plane for rotation.
    headache frequency
    the number of days the subjects feel headache (headache frequency).
    medication intake
    from the patients' diary in the last week , medications 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
    headache duration
    the total hours of headache (headache duration).

    Full Information

    First Posted
    June 26, 2022
    Last Updated
    July 2, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05446649
    Brief Title
    Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache
    Acronym
    DN
    Official Title
    Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 5, 2022 (Anticipated)
    Primary Completion Date
    October 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (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
    the aim of this study is to investigate the efficacy of Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache
    Detailed Description
    Cervicogenic headache has been classified as a secondary type headache, and it is usually associated with cervical myofascial pain sources as myofascial trigger points . It also could be related to any joint, disc, and ligament disease of the upper region of the neck.physiotherapist use trigger point dry needling as an invasive treatment for CGH where a solid filament needle is inserted into a myofascial trigger point . The advantages of Dry needling are increasingly documented .Instrument-assisted soft tissue mobilization technique has been reported to decrease pain, improve overall function, and increase range of motion . It enhances the ability of physical therapists to detect altered tissue properties, through the vibration sense within the instrument, and to treat soft tissue dysfunction. It also enhances the patient's awareness of altered sensations within the treated tissues.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    dry needling and instrumented assisted soft tissue mobilization
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    random generator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dry needling
    Arm Type
    Experimental
    Arm Description
    the patient will receive dry needling and conventional therapy three times per week for four weeks
    Arm Title
    instrumented assisted soft tissue mobilization
    Arm Type
    Experimental
    Arm Description
    the patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks
    Arm Title
    conventional therapy
    Arm Type
    Active Comparator
    Arm Description
    the patient will receive conventional therapy three times per week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    dry needling
    Intervention Description
    the patient will be in comfortable position .and clean the area over upper trapezius and sub occipital muscles. detect the trigger point then Perpendicular needling into the bulk of the muscle is the safest technique for this area.
    Intervention Type
    Other
    Intervention Name(s)
    instrumented assisted soft tissue mobilization
    Intervention Description
    the patients will be in sitting position. The appropriate IASTM 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 investing the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sub occipital and upper fibers of trapezius muscle. The IASTM technique will be applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, followed 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. The patients will be advised that they might be sore, bruised, or have small red dots called petechiae, on the treated area. Ice will be applied for 15 to 20 min after the treatment if there will be a massive soreness.
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Intervention Description
    patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    visual analogue scale will be used to asses pain intensity which patient will be instructed to put point on line from no pain to tolerable pain. The scale consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel .
    Time Frame
    up to four weeks
    Title
    neck disability
    Description
    will be measured by Arabic neck disability index. It contains ten category/classes. Each category contains six choices (zero-five).Score from zero to four no disability, from five to 15 this is mild, From 15 to 24 this is moderate, from 25 to 34 this is severe, more than 34 this is a complete disability
    Time Frame
    up to four weeks
    Title
    pressure pain threshold
    Description
    pressure pain threshold will be assessed by commander algometer
    Time Frame
    up to four weeks
    Secondary Outcome Measure Information:
    Title
    range of motion
    Description
    range of motion will be measured by inclinometer CROM. The CROM (deluxe version - Performance Attainment Associates, Roseville, MN, USA) measures the cervical range of motion5- for flexion, extension, lateral flexion, and rotation using separate inclinometers. These inclinometers are attached to a frame similar to that for eyeglasses one in the sagittal plane for flexion - extension, second in the frontal plane for lateral flexion and a third in the horizontal plane for rotation.
    Time Frame
    up to four weeks
    Title
    headache frequency
    Description
    the number of days the subjects feel headache (headache frequency).
    Time Frame
    up to four weeks
    Title
    medication intake
    Description
    from the patients' diary in the last week , medications 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 four weeks
    Title
    headache duration
    Description
    the total hours of headache (headache duration).
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20 to 60 years old patient with unilaterally 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 with reduced neck ROM headache intensity pain score of at least 20mm on the Visual analogue scale (VAS) 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 and central nervous system involvement, previous head or neck surgery or whiplash injury history within the last 6 weeks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alshaymaa sh abd el-azeim, lecturer
    Phone
    01033771553
    Email
    alshaymaa.shaaban@pt.cu.edu.eg

    12. IPD Sharing Statement

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    Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache

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