Cervicogenic HeadacheIASTMNCT05545423
Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache
A study testing instrumented assisted soft tissue mobilization and traditional therapy in people with Cervicogenic Headache, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- instrumented assisted soft tissue mobilization and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 30 Mar 2023
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 35 to 50 years old
- unilaterality 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, reduced neck ROM
- headache intensity pain score of at least 20mm on the Visual Analogue Scale,
- 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
Show all 16Show fewer
- prolonged history of steroid use
- resting blood pressure greater than 140/90 mmHg
- cervical spinal stenosis
- diminished sensation
- central nervous system involvement
- previous head or neck surgery
- whiplash injury history within the last 6 weeks
- head or neck pain treatment within the last month from any practitioner and PT approach for head or neck pain within the last 3 months
- open wounds and psychiatric/cognitive disorders
- patients contraindicated to carotid artery massage
About this study
Official title: Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache: A Parallel Group, Randomized Controlled Trial
This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.
Read the detailed description
The International Headache Society has classified the cervicogenic headache as a secondary headache type that is hypothesized to originate due to nociception in the cervical area. The main difference between these patients with and without cervicogenic headache is the lateralization of pressure hyperalgesia to the painful side of the head and neck, there is a unilateral pattern of pressure hyperalgesia in the head and neck that typifies the altered sensory processing in patients with cervicogenic headache. Cervicogenic headache pain has been mostly related to joint, disc and ligament disease of the upper cervical spine. However, the upper cervical nerves also receive afferent inputs from the muscle tissues.
Several physical therapy techniques are proposed for this type of headache. Strength and endurance exercises, when accompanied by stretching exercises, were shown to be an effective treatment for cervicogenic headache patients. The lack of solid evidence of positive effects and risks of serious complications for spinal manipulation should be considered in favor of other physical therapy options associated with less risk. Graston Technique is an instrument assisted soft tissue mobilization (IASTM) treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. It thus creates an inflammatory response to accelerate the healing process and restore flexible, normal tissue. This technique seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis. eighty patients with carcinogenic headache will be allocated randomly to two equal group. one group will receive IASTM and traditional therapy and other will receive traditional only for eight weeks.
- Conditions
- Cervicogenic Headache
- Being tested
- instrumented assisted soft tissue mobilization, traditional therapy
- Keywords
- instrumented assisted soft tissue mobilization, cervicogenic headache, proprioception
- 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.
instrumented assisted soft tissue mobilizationOther
the appropriate Graston 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 invested the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sternocleidomastoids and upper fibers of trapezius muscles. The IASTM technique was applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, following 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.
traditional therapyOther
The exercise program will be in the form of stretching exercises for the sternocleidomastoids (SCM), the scalenes, and upper fibers of trapezius; strengthening isometric exercises for the neck flexors, extensors, lateral flexors, and neck rotators; and postural correction and scapular stabilization exercises
| Study group | Role | What they receive |
|---|---|---|
| instrumented assisted soft tissue mobilization | Experimental | patients will receive IASTM three times a week for eight weeks Receives: Other: instrumented assisted soft tissue mobilization; Other: traditional therapy |
| traditional therapy | Active comparator | patients will receive traditional therapy three times a week for eight weeks Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
joint position error
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).
Measured: up to eight weeks
Secondary outcomes (9)
disability
The neck disability index (NDI) will be used for measuring neck disability and it is a self-patient-completed questionnaire that measures patients' functional status. It contains 10 questions regarding pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six answer choices scored from 0 to 5 as 0 indicates no disability and 5 indicates complete disability. All sections are scored then totaled on a scale from 0 to 50, as zero is the best possible score and 50 is the worst one
Measured: up to eight weeks
headache frequency
the number of days the patients feel headache
Measured: up to eight weeks
headache duration
the total hour of headache
Measured: up to eight weeks
medication intake
from the patient diary in the last week, medication 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 eight weeks
pain intensity
Visual Analogue Scale which is a 100-mm horizontal line will be used for measuring pain intensity. The patients will be instructed to represent their pain intensity level by marking anywhere on the line with "no pain" on the left side and "worst pain" on the right side.
Measured: up to eight weeks
forward head posture
cervical range of motion 2 (CROM2 ruler will be used for assess the forward head posture
Measured: up to eight weeks
rounded shoulder assessment
tape measurement will be used to to assess rounded shoulder: Subjects will be requested to stand normally with their hands hanging beside their bodies to test for rounded shoulder posture. Then, sternal notch, coracoid process, posteriolateral angle of the acromion process and the adjacent thoracic spinous process will be palpated and marked. The distance between sternal notch and coracoid process, and the distance between the posterolateral angle of the acromion process and the adjacent thoracic spinous process will measured by using tape.
Measured: up to eight weeks
suboccipital flexion and extension of cervical vertebra
The cervical range of motion device (CROM) will measure suboccipital flexion and extension of cervical vertebrae. Instruct the subject to position the CROM Instrument as if putting on a pair of glasses. Fasten the velcro strap in line with the bows. Instruct the subject to stand facing away from an outside corner of a wall or edge of an open door frame. The subject's sacrum, thoracic spine, and occiput must be in contact with the corner of the wall or door edge. Instruct the subject to flex the suboccipital area as much as possible while maintaining equal pressure on the skull, thorax, and sacrum. Record this measurement. Instruct the subject to extend the suboccipital area as much as possible without allowing the skull, thorax, and sacrum to leave the contact surface.
Measured: up to eight weeks
headache disability
headache-specific disability questionnaire will be used to assess headache disability. the questionnaire has 9 items. the score for each one from 0 to 10. a score of 10-28% is considered to constitute mild disability; 30-48% is moderate; 50-68% is severe; 72% or more is complete.
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- instrument-assisted soft tissue mobilization and traditional therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545423
- Sponsor's protocol ID
- P.T.REC/012/002832
- Acronym
- IASTM
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache: A Parallel Group, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05545423
- Acronym / sponsor ID
- IASTM / P.T.REC/012/002832
- Conditions
- Cervicogenic Headache
- Keywords
- instrumented assisted soft tissue mobilization, cervicogenic headache, proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 19 Sep 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.
This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.
Detailed description
The International Headache Society has classified the cervicogenic headache as a secondary headache type that is hypothesized to originate due to nociception in the cervical area. The main difference between these patients with and without cervicogenic headache is the lateralization of pressure hyperalgesia to the painful side of the head and neck, there is a unilateral pattern of pressure hyperalgesia in the head and neck that typifies the altered sensory processing in patients with cervicogenic headache. Cervicogenic headache pain has been mostly related to joint, disc and ligament disease of the upper cervical spine. However, the upper cervical nerves also receive afferent inputs from the muscle tissues.
Several physical therapy techniques are proposed for this type of headache. Strength and endurance exercises, when accompanied by stretching exercises, were shown to be an effective treatment for cervicogenic headache patients. The lack of solid evidence of positive effects and risks of serious complications for spinal manipulation should be considered in favor of other physical therapy options associated with less risk. Graston Technique is an instrument assisted soft tissue mobilization (IASTM) treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. It thus creates an inflammatory response to accelerate the healing process and restore flexible, normal tissue. This technique seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis. eighty patients with carcinogenic headache will be allocated randomly to two equal group. one group will receive IASTM and traditional therapy and other will receive traditional only for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- instrument-assisted soft tissue mobilization and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| instrumented assisted soft tissue mobilization | Experimental | Other: instrumented assisted soft tissue mobilization, Other: traditional therapypatients will receive IASTM three times a week for eight weeks |
| traditional therapy | Active comparator | Other: traditional therapypatients will receive traditional therapy three times a week for eight weeks |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 35 to 50 years old
- unilaterality 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, reduced neck ROM
- headache intensity pain score of at least 20mm on the Visual Analogue Scale,
Key exclusion criteria (16 listed)
- migraine
- tension-type headache
- tumor
- osteoporosis
- fracture
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 |
|---|---|---|
| instrumented assisted soft tissue mobilizationthe appropriate Graston 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 invested the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sternocleidomastoids and upper fibers of trapezius muscles. The IASTM technique was applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, following 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. | Other | instrumented assisted soft tissue mobilization |
| traditional therapyThe exercise program will be in the form of stretching exercises for the sternocleidomastoids (SCM), the scalenes, and upper fibers of trapezius; strengthening isometric exercises for the neck flexors, extensors, lateral flexors, and neck rotators; and postural correction and scapular stabilization exercises | Other | instrumented assisted soft tissue mobilization, traditional therapy |
Primary outcome
joint position error
Time frame: up to eight weeks
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).
9 secondary outcomes
disability
Time frame: up to eight weeks
headache frequency
Time frame: up to eight weeks
headache duration
Time frame: up to eight weeks
medication intake
Time frame: up to eight weeks
pain intensity
Time frame: up to eight weeks
forward head posture
Time frame: up to eight weeks
rounded shoulder assessment
Time frame: up to eight weeks
suboccipital flexion and extension of cervical vertebra
Time frame: up to eight weeks
headache disability
Time frame: up to eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing instrumented assisted soft tissue mobilization and traditional therapy in people with Cervicogenic Headache, run by Cairo University.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
joint position error (time frame: up to eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2022.