NCT05446649

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

June 26, 2022

Last Update Submit

September 6, 2024

Conditions

Keywords

dry needlingcervicogenic headacheinstrumented assisted soft tissue mobilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • pressure pain threshold

    pressure pain threshold will be assessed by commander algometer

    up to four weeks

Secondary Outcomes (4)

  • range of motion

    up to four weeks

  • headache frequency

    up to four weeks

  • medication intake

    up to four weeks

  • headache duration

    up to four weeks

Study Arms (3)

dry needling

EXPERIMENTAL

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

Other: dry needlingOther: conventional therapy

instrumented assisted soft tissue mobilization

EXPERIMENTAL

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

Other: instrumented assisted soft tissue mobilizationOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

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

Other: conventional therapy

Interventions

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.

dry needling

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.

instrumented assisted soft tissue mobilization

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

conventional therapydry needlinginstrumented assisted soft tissue mobilization

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alshaymaa Shaaban Abd El-Azeim

Giza, 11432, Egypt

Location

Related Publications (1)

  • Elhafez HM, Mohammed OA, Fahmy EM, Elkhateeb YS, Abd El-Azeim AS. Dry needling versus instrument assisted soft tissue mobilization in patients with cervicogenic headache: a randomized controlled trial. Disabil Rehabil. 2025 Dec 23:1-13. doi: 10.1080/09638288.2025.2605621. Online ahead of print.

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: dry needling and instrumented assisted soft tissue mobilization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 26, 2022

First Posted

July 7, 2022

Study Start

August 30, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations