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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05446649
Collaborator
(none)
60
3
3.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: dry needling
  • Other: instrumented assisted soft tissue mobilization
  • Other: conventional therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
dry needling and instrumented assisted soft tissue mobilizationdry needling and instrumented assisted soft tissue mobilization
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
random generator
Primary Purpose:
Treatment
Official Title:
Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial
Anticipated Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: dry needling

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

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.

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

Experimental: instrumented assisted soft tissue mobilization

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

Other: 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.

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

Active Comparator: conventional therapy

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

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

Outcome Measures

Primary Outcome Measures

  1. 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 .

  2. 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

  3. pressure pain threshold [up to four weeks]

    pressure pain threshold will be assessed by commander algometer

Secondary Outcome Measures

  1. 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.

  2. headache frequency [up to four weeks]

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

  3. 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

  4. headache duration [up to four weeks]

    the total hours of headache (headache duration).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Al Shaymaa Shaaban Abd El Azeim, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05446649
Other Study ID Numbers:
  • p.t.rec/012/003725
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Al Shaymaa Shaaban Abd El Azeim, principal investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022