Cervicogenic HeadacheDNNCT05446649
Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache
A study testing dry needling, instrumented assisted soft tissue mobilization and conventional therapy in people with Cervicogenic Headache, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- dry needling, instrumented assisted soft tissue mobilization and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial
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
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- dry needling, instrumented assisted soft tissue mobilization, conventional therapy
- Keywords
- dry needling, cervicogenic headache, instrumented assisted soft tissue mobilization
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
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 mobilizationOther
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 therapyOther
patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)
| Study group | Role | What they receive |
|---|---|---|
| dry needling | Experimental | the patient will receive dry needling and conventional therapy three times per week for four weeks Receives: Other: dry needling; Other: 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 Receives: Other: instrumented assisted soft tissue mobilization; Other: conventional therapy |
| conventional therapy | Active comparator | the patient will receive conventional therapy three times per week for four weeks Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measured: up to four weeks
pressure pain threshold
pressure pain threshold will be assessed by commander algometer
Measured: up to four weeks
Secondary outcomes (4)
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 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.
Measured: up to four weeks
headache frequency
the number of days the subjects feel headache (headache frequency).
Measured: up to four weeks
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
Measured: up to four weeks
headache duration
the total hours of headache (headache duration).
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start30 Aug 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dry needling and instrumented assisted soft tissue mobilization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446649
- Sponsor's protocol ID
- p.t.rec/012/003725
- Acronym
- DN
- Status last verified
- Sep 2024
- First submitted
- 26 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jul;48(14):4602-4614. doi: 10.1080/09638288.2025.2605621. Epub 2025 Dec 23.
PubMed 41437643
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05446649
- Acronym / sponsor ID
- DN / p.t.rec/012/003725
- Conditions
- Cervicogenic Headache
- Keywords
- dry needling, cervicogenic headache, instrumented assisted soft tissue mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- dry needling and instrumented assisted soft tissue mobilization
| Arm | Type | Receives |
|---|---|---|
| dry needling | Experimental | Other: dry needling, Other: conventional therapythe patient will receive dry needling and conventional therapy three times per week for four weeks |
| instrumented assisted soft tissue mobilization | Experimental | Other: instrumented assisted soft tissue mobilization, Other: conventional therapythe patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks |
| conventional therapy | Active comparator | Other: conventional therapythe patient will receive conventional therapy three times per week for four weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingthe 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 | dry needling |
| instrumented assisted soft tissue mobilizationthe 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 | instrumented assisted soft tissue mobilization |
| conventional therapypatients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise) | Other | conventional therapy, dry needling, instrumented assisted soft tissue mobilization |
Primary outcome
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 .
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
pressure pain threshold
Time frame: up to four weeks
pressure pain threshold will be assessed by commander algometer
4 secondary outcomes
range of motion
Time frame: up to four weeks
headache frequency
Time frame: up to four weeks
medication intake
Time frame: up to four weeks
headache duration
Time frame: up to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41437643Elhafez 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. 2026 Jul;48(14):4602-4614. doi: 10.1080/09638288.2025.2605621. Epub 2025 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling, instrumented assisted soft tissue mobilization and conventional therapy in people with Cervicogenic Headache, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.