Suboccipital ReleaseNCT06703385
Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
A study testing Instrument Assisted soft tissue mobilization, Suboccipital release and conventional physical therapy program in people with Suboccipital Release and Instrumental Assisted Soft Tissue Mobilization, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suboccipital Release, Instrumental Assisted Soft Tissue Mobilization, Tension-Type Headache
- What is being tested?
- Instrument Assisted soft tissue mobilization, Suboccipital release and conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants of both gender will be between the ages of 18 and 60.
- Episodic tension type headache criteria, according to the International Headache Society's Headache Classification Committee., have at least two of the following characteristics.
- Recurrent episodes of headache on less than 15 days per month for at least 3 months
- Headache that last for from around 30 min till seven days.
- At least 2 of the following features are found in a headache:
- A location that is on two sides.
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- Tightening/pressing quality (non-pulsating).
- Intensity is mild to moderate.
- Both of the following: Not worsened by routine physical activity, there is no nausea or vomiting.
- Only have one photophobia/ phonophobia
- Patients have active trigger points in suboccipital muscle and upper trapezius muscle
- The presence of myofascial trigger points was determined by therapist using the diagnostic criteria described by Simons .,(1999) ,The major criteria of active myofascial trigger points were: Regional neck pain, Pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point, Taut band palpable in an accessible muscle.
Who cannot join
- Patients who have had a history of cancer
- Patients who have had cervical and cranial surgery
- Patients with severe psychological disorders (major Depression)
- Patients with uncontrolled hypertension
- Dysfunctions in the tempo-mandibular joint
- Headaches associated with high fever, stiff neck, or rash, problems of vision or profound dizziness
- Female who are pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
out-patient clinic, national institute of neuromotor system, Egypt
Cairo
Nada Gamal Saad, physical therapist, 01090415655, nadagamal004@gmail.com
About this study
Official title: Effect of Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
The study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. The research will also examine the effects of these methods on headache impact tests and frequency.
Read the detailed description
Headache prevalence ranges from 38.2 to 59.4%, with a lifetime prevalence of 26.1-45%. Tension Type Headache can be episodic or chronic, with 78% occurring less than 15 times/month and 6% occurring more than 15 times/month. Tension Type Headache has a greater socioeconomic burden, leading to lower productivity and workday loss. Tension Type Headache is linked to myofascial pain and trigger points, which can cause sensory changes and reduced pain threshold. Studies show that referred pain from myofascial trigger points reproduces headache in patients with , leading to increased symptom severity. Frequent Episodic tension type headache increases the risk of developing chronic tension type headache due to analgesic overuse. instrumental assisted soft tissue mobilization, a physical therapy technique, promotes fascia realignment and reduces strain on the clinician's hands.
- Conditions
- Suboccipital Release, Instrumental Assisted Soft Tissue Mobilization, Tension-Type Headache
- Being tested
- Instrument Assisted soft tissue mobilization, Suboccipital release, conventional physical therapy program
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted soft tissue mobilizationOther
The blade is a surgical instrument for soft tissue mobilization, made of 100% surgical stainless steel with 8 treatment planes and 2 treatment edges. It is used to locate muscle limitations and apply gentle strokes along the affected muscle, detecting changes in soft tissue consistency. The procedure is repeated three times a week for four weeks.
Suboccipital releaseOther
The patient will lie in a relaxed supine position, with a therapist sitting on a chair. The therapist will apply pressure to the C2 area, holding it until a melting sensation is felt. The intervention time is 4 minutes. The patient will close both eyes during the Suboccipital release procedure to prevent eye movements affecting muscle tone. Interventions will be three times a week for four weeks.
conventional physical therapy programOther
The patient is placed in a sitting position and a hot pack is applied to the back of the neck for 15 minutes. The therapist then performs active range of motion exercises for neck flexion, extension, rotation, and lateral flexion without resistance. They also perform stretching exercises for upper Trapezius muscle and suboccipital muscle. Strengthening exercises for neck muscles are performed through isometric exercises, such as side pending to right, side pending to left, extension, and flexion. The interventions are conducted three times, peer-wise, for four weeks. The treatment aims to improve neck flexibility and overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| conventional program | Active comparator | Twenty patients will receive conventional physical therapy including Hot pack and exercise therapy program (ROM exercise, stretching exercise, isometric strengthening exercise for cervical muscles Receives: Other: conventional physical therapy program |
| suboccipital release | Experimental | Twenty patients will receive suboccipital release plus the Same conventional physical therapy program. Receives: Other: Suboccipital release; Other: conventional physical therapy program |
| instrumental assisted soft tissue mobilization | Experimental | Twenty patients will receive instrumental assisted soft tissue mobilization plus the Sam conventional physical therapy program. Receives: Other: Instrument Assisted soft tissue mobilization; Other: conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pain intensity using numeric pain rating scale
Assessment of pain intensity using Numerical pain Rating Scale An 1l-point numeric scale with 0 representing one pain extreme(e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable)
Measured: at baseline and after 4 weeks
Secondary outcomes (3)
Assessment of pressure pain threshold using pressure algometer
The Pain Pressure Threshold is measured using a pressure algometer on trapezius and suboccipital trigger points. The patient's maximum pain tolerance is recorded, and the procedure is repeated three times to calculate the average.
Measured: at baseline and after 4 weeks
Assessment of the impact of headache using the Headache Impact Test questionnaire
The Headache Impact Test (HIT-6) is a questionnaire measuring the impact of headaches on daily activities. It consists of six questions, each scoring 6-13, with a final score ranging from 36 to 78. A higher score indicates more headache-related disability. The test categorizes headache impact severity into four categories: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
Measured: at baseline and after 4 weeks
Assessment of Frequency of headache
The number of headache days per week will be used to identify it. The participant keep count of how many days they have a headache in the week previous treatment and after four weeks of treatment
Measured: at baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suboccipital ReleaseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Gamal Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703385
- Sponsor's protocol ID
- Nada-005491
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
- ClinicalTrials.gov ID
- NCT06703385
- Acronym / sponsor ID
- Nada-005491
- Conditions
- Suboccipital Release, Instrumental Assisted Soft Tissue Mobilization, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 25 Nov 2024 (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 study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. The research will also examine the effects of these methods on headache impact tests and frequency.
Detailed description
Headache prevalence ranges from 38.2 to 59.4%, with a lifetime prevalence of 26.1-45%. Tension Type Headache can be episodic or chronic, with 78% occurring less than 15 times/month and 6% occurring more than 15 times/month. Tension Type Headache has a greater socioeconomic burden, leading to lower productivity and workday loss. Tension Type Headache is linked to myofascial pain and trigger points, which can cause sensory changes and reduced pain threshold. Studies show that referred pain from myofascial trigger points reproduces headache in patients with , leading to increased symptom severity. Frequent Episodic tension type headache increases the risk of developing chronic tension type headache due to analgesic overuse. instrumental assisted soft tissue mobilization, a physical therapy technique, promotes fascia realignment and reduces strain on the clinician's hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional program | Active comparator | Other: conventional physical therapy programTwenty patients will receive conventional physical therapy including Hot pack and exercise therapy program (ROM exercise, stretching exercise, isometric strengthening exercise for cervical muscles |
| suboccipital release | Experimental | Other: Suboccipital release, Other: conventional physical therapy programTwenty patients will receive suboccipital release plus the Same conventional physical therapy program. |
| instrumental assisted soft tissue mobilization | Experimental | Other: Instrument Assisted soft tissue mobilization, Other: conventional physical therapy programTwenty patients will receive instrumental assisted soft tissue mobilization plus the Sam conventional physical therapy program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants of both gender will be between the ages of 18 and 60.
- Episodic tension type headache criteria, according to the International Headache Society's Headache Classification Committee., have at least two of the following characteristics.
- Patients have active trigger points in suboccipital muscle and upper trapezius muscle
- The presence of myofascial trigger points was determined by therapist using the diagnostic criteria described by Simons .,(1999) ,The major criteria of active myofascial trigger points were: Regional neck pain, Pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point, Taut band palpable in an accessible muscle.
Key exclusion criteria (7 listed)
- Patients who have had a history of cancer
- Patients who have had cervical and cranial surgery
- Patients with severe psychological disorders (major Depression)
- Patients with uncontrolled hypertension
- Dysfunctions in the tempo-mandibular joint
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 Assisted soft tissue mobilizationThe blade is a surgical instrument for soft tissue mobilization, made of 100% surgical stainless steel with 8 treatment planes and 2 treatment edges. It is used to locate muscle limitations and apply gentle strokes along the affected muscle, detecting changes in soft tissue consistency. The procedure is repeated three times a week for four weeks. | Other | instrumental assisted soft tissue mobilization |
| Suboccipital releaseThe patient will lie in a relaxed supine position, with a therapist sitting on a chair. The therapist will apply pressure to the C2 area, holding it until a melting sensation is felt. The intervention time is 4 minutes. The patient will close both eyes during the Suboccipital release procedure to prevent eye movements affecting muscle tone. Interventions will be three times a week for four weeks. | Other | suboccipital release |
| conventional physical therapy programThe patient is placed in a sitting position and a hot pack is applied to the back of the neck for 15 minutes. The therapist then performs active range of motion exercises for neck flexion, extension, rotation, and lateral flexion without resistance. They also perform stretching exercises for upper Trapezius muscle and suboccipital muscle. Strengthening exercises for neck muscles are performed through isometric exercises, such as side pending to right, side pending to left, extension, and flexion. The interventions are conducted three times, peer-wise, for four weeks. The treatment aims to improve neck flexibility and overall well-being. | Other | conventional program, instrumental assisted soft tissue mobilization, suboccipital release |
Primary outcome
assessment of pain intensity using numeric pain rating scale
Time frame: at baseline and after 4 weeks
Assessment of pain intensity using Numerical pain Rating Scale An 1l-point numeric scale with 0 representing one pain extreme(e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable)
3 secondary outcomes
Assessment of pressure pain threshold using pressure algometer
Time frame: at baseline and after 4 weeks
Assessment of the impact of headache using the Headache Impact Test questionnaire
Time frame: at baseline and after 4 weeks
Assessment of Frequency of headache
Time frame: at baseline and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
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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.
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 Assisted soft tissue mobilization, Suboccipital release and conventional physical therapy program in people with Suboccipital Release and Instrumental Assisted Soft Tissue Mobilization, 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 12 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada Gamal Saad, physical therapist (01090415655, nadagamal004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain intensity using numeric pain rating scale (time frame: at baseline and after 4 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 27 Nov 2024.