Skip to main content
OpenTrials
Completed

NCT Number: NCT05446649

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alshaymaa Shaaban Abd El-Azeim

Giza, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Other

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

Other

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

Other

patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)

Primary outcomes

  1. pain intensity

    Time frame: 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 .

  2. neck disability

    Time frame: 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

  3. pressure pain threshold

    Time frame: up to four weeks

    pressure pain threshold will be assessed by commander algometer

Secondary outcomes

  1. range of motion

    Time frame: 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.

  2. headache frequency

    Time frame: up to four weeks

    the number of days the subjects feel headache (headache frequency).

  3. medication intake

    Time frame: 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

  4. headache duration

    Time frame: up to four weeks

    the total hours of headache (headache duration).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial

Acronym: DN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.