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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05446649
Other study ID # p.t.rec/012/003725
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 5, 2022
Est. completion date October 30, 2022

Study information

Verified date July 2022
Source Cairo University
Contact alshaymaa sh abd el-azeim, lecturer
Phone 01033771553
Email alshaymaa.shaaban@pt.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
dry needling
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.
instrumented assisted soft tissue mobilization
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.
conventional therapy
patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . up to four weeks
Primary 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 up to four weeks
Primary pressure pain threshold pressure pain threshold will be assessed by commander algometer up to four weeks
Secondary 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 ?exion, extension, lateral ?exion, and rotation using separate inclinometers. These inclinometers are attached to a frame similar to that for eyeglasses one in the sagittal plane for ?exion - extension, second in the frontal plane for lateral ?exion and a third in the horizontal plane for rotation. up to four weeks
Secondary headache frequency the number of days the subjects feel headache (headache frequency). up to four weeks
Secondary 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 up to four weeks
Secondary headache duration the total hours of headache (headache duration). up to four weeks
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