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
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
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
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
Learn more about this trial
Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache
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