Cervicogenic HeadacheNCT05249647
Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients
A study testing Instrument based Fascial abrasion technique and Myofascial release technique in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Instrument based Fascial abrasion technique and Myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2022to 13 Jul 2022
- 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 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having headaches with neck stiffness and pain.
- Headache for the past 3 months at least once per week.
- Positive flexion rotation test and restriction greater than 10°
- Patient aged 18-66 years old.
Who cannot join
- Headache not of cervical origin.
- Physiotherapy or chiropractic treatment in the past 3 months.
- Headache with autonomic involvement, dizziness and visual disturbance.
- Congenital conditions of Cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache
Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.
Read the detailed description
Cervicogenic headache is a symptomatic headache characterized by chronic, hemi cranial pain syndrome in which pain sensations originates in cervical spine and soft tissues of the neck and basically referred to head. Cervicogenic headache originates in the upper cervical region, and the headache mechanism involves nociceptive structures such as the upper cervical spinal nerves, ganglia, disks, facet joints, muscles, and ligaments. Consequently, the anatomical structures innervated by cervical roots C1-C3 are potential sources of Cervicogenic headache.
Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) with the intention of restoring decrease pain, optimizing length and facilitating the release of fascial restrictions caused by injury, stress, repetitive use, etc. There are some studies about MFR and its effects which include: increase extensibilities of soft tissues, increase ROM, improves joint biomechanics, increases temperature of fascia, increases blood circulation to the muscles and decreases pain and muscles tone significantly.
Although; a lot of remedies such as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache, but sub-occipital MFR for Cervicogenic headache has not been studied specifically. Another technique used for cervicogenic headache includes Fascial Abrasion Technique tool that is a revolutionary tool that can quickly and effectively loosen muscle tissue/fascia. It improves range and quality of movement.
- Conditions
- Cervicogenic Headache
- Being tested
- Instrument based Fascial abrasion technique, Myofascial release technique
- Keywords
- Neck and head pain
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument based Fascial abrasion techniqueOther
Also called Instrument based soft tissue release technique
Participants were in a comfortable position during treatment. Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application. Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place \& the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping. Fascial Abrasion tool was washed in alcohol-based sanitizer before and after every treatment session and all norms of COVID-19 precautions were maintained. Myofascial trigger points were marked with a 1×1 cm piece of tape/under wrap to confirm consistency of subsequent treatments.
Myofascial release techniqueOther
Also called Soft tissue release technique
All participants will get Conventional therapy i.e heating pad for 10 minutes. For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull. This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Instrument based fascial abrasion technique | Experimental | IASTM using tools over Myofascial trigger points of the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Participants were in a comfortable position during treatment. Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application. Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place \& the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping. Receives: Other: Instrument based Fascial abrasion technique |
| Myofascial release technique | Active comparator | All participants will get Conventional therapy i.e heating pad for 10 minutes. For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull. This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks. Receives: Other: Myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale for pain
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
Measured: 6 weeks
Neck disability index to measure functional status of neck
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform.
Measured: 6 weeks
Medical outcome study( MOS-36) to measure functions of daily living
Questionnaire consists of 11 questions regarding functions of daily living
Measured: 6 weeks
Secondary outcomes (1)
Measuring tape for measuring ranges at cervical region
It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start25 Jan 2022
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
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 Riphah International 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249647
- Sponsor's protocol ID
- REC/RCR&AH/21/0128/Warda Zafar
- Status last verified
- Dec 2022
- First submitted
- 1 Feb 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05249647
- Acronym / sponsor ID
- REC/RCR&AH/21/0128/Warda Zafar
- Conditions
- Cervicogenic Headache
- Keywords
- Neck and head pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 22 Feb 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.
Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.
Detailed description
Cervicogenic headache is a symptomatic headache characterized by chronic, hemi cranial pain syndrome in which pain sensations originates in cervical spine and soft tissues of the neck and basically referred to head. Cervicogenic headache originates in the upper cervical region, and the headache mechanism involves nociceptive structures such as the upper cervical spinal nerves, ganglia, disks, facet joints, muscles, and ligaments. Consequently, the anatomical structures innervated by cervical roots C1-C3 are potential sources of Cervicogenic headache.
Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) with the intention of restoring decrease pain, optimizing length and facilitating the release of fascial restrictions caused by injury, stress, repetitive use, etc. There are some studies about MFR and its effects which include: increase extensibilities of soft tissues, increase ROM, improves joint biomechanics, increases temperature of fascia, increases blood circulation to the muscles and decreases pain and muscles tone significantly.
Although; a lot of remedies such as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache, but sub-occipital MFR for Cervicogenic headache has not been studied specifically. Another technique used for cervicogenic headache includes Fascial Abrasion Technique tool that is a revolutionary tool that can quickly and effectively loosen muscle tissue/fascia. It improves range and quality of movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument based fascial abrasion technique | Experimental | Other: Instrument based Fascial abrasion techniqueIASTM using tools over Myofascial trigger points of the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Participants were in a comfortable position during treatment. Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application. Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place \& the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping. |
| Myofascial release technique | Active comparator | Other: Myofascial release techniqueAll participants will get Conventional therapy i.e heating pad for 10 minutes. For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull. This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having headaches with neck stiffness and pain.
- Headache for the past 3 months at least once per week.
- Positive flexion rotation test and restriction greater than 10°
- Patient aged 18-66 years old.
Key exclusion criteria (4 listed)
- Headache not of cervical origin.
- Physiotherapy or chiropractic treatment in the past 3 months.
- Headache with autonomic involvement, dizziness and visual disturbance.
- Congenital conditions of Cervical spine
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 |
|---|---|---|
| Instrument based Fascial abrasion techniqueAlso: Instrument based soft tissue release techniqueParticipants were in a comfortable position during treatment. Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application. Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place \& the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping. Fascial Abrasion tool was washed in alcohol-based sanitizer before and after every treatment session and all norms of COVID-19 precautions were maintained. Myofascial trigger points were marked with a 1×1 cm piece of tape/under wrap to confirm consistency of subsequent treatments. | Other | Instrument based fascial abrasion technique |
| Myofascial release techniqueAlso: Soft tissue release techniqueAll participants will get Conventional therapy i.e heating pad for 10 minutes. For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull. This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks. | Other | Myofascial release technique |
Primary outcome
Numeric pain rating scale for pain
Time frame: 6 weeks
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
Neck disability index to measure functional status of neck
Time frame: 6 weeks
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform.
Medical outcome study( MOS-36) to measure functions of daily living
Time frame: 6 weeks
Questionnaire consists of 11 questions regarding functions of daily living
1 secondary outcome
Measuring tape for measuring ranges at cervical region
Time frame: 6 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 12 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Cervicogenic Headache
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Recruiting
Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
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.
Muhammad Sanaullah, MS principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument based Fascial abrasion technique and Myofascial release technique in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 4 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 12 Dec 2022. 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 Pakistan. 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?
Numeric pain rating scale for pain (time frame: 6 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?
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 12 Dec 2022.