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

Not Applicable

• Conditions: Cervicogenic Headache
• Interventions: Other: instrumented assisted soft tissue mobilization; Other: conventional therapy; Other: dry needling

• Registration Number: NCT05446649
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2022-06-26
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-02
• Last Update Submitted: 2022-07-02
• Study Start: 2022-07-05
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
instrumented assisted soft tissue mobilization	instrumented assisted soft tissue mobilization	the patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks
conventional therapy	conventional therapy	the patient will receive conventional therapy three times per week for four weeks
dry needling	dry needling	the patient will receive dry needling and conventional therapy three times per week for four weeks
dry needling	conventional therapy	the patient will receive dry needling and conventional therapy three times per week for four weeks
instrumented assisted soft tissue mobilization	conventional therapy	the patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks

Primary Outcome Measures

Name	Time	Method
pressure pain threshold	up to four weeks	pressure pain threshold will be assessed by commander algometer
pain intensity	up to four weeks	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	up to four weeks	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

Secondary Outcome Measures

Name	Time	Method
medication intake	up to four weeks	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
range of motion	up to four weeks	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	up to four weeks	the number of days the subjects feel headache (headache frequency).
headache duration	up to four weeks	the total hours of headache (headache duration).

Trial Locations

Locations (1)

Alshaymaa Shaaban Abd El-Azeim; 🇪🇬 Giza, Egypt