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Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache

Effect of Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06703385
Enrollment
60
Registered
2024-11-25
Start date
2024-12-01
Completion date
2025-04-01
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suboccipital Release, Instrumental Assisted Soft Tissue Mobilization, Tension-Type Headache

Brief 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. 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.

Interventions

OTHERInstrument Assisted soft tissue mobilization

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.

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.

OTHERconventional physical therapy program

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Participants of both gender will be between the ages of 18 and 60. 2. 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. * 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 3. Patients have active trigger points in suboccipital muscle and upper trapezius muscle 4. 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.

Exclusion criteria

1. Patients who have had a history of cancer 2. Patients who have had cervical and cranial surgery 3. Patients with severe psychological disorders (major Depression) 4. Patients with uncontrolled hypertension 5. Dysfunctions in the tempo-mandibular joint 6. Headaches associated with high fever, stiff neck, or rash, problems of vision or profound dizziness 7. Female who are pregnant or lactating

Design outcomes

Primary

MeasureTime frameDescription
assessment of pain intensity using numeric pain rating scaleat baseline and after 4 weeksAssessment 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)

Secondary

MeasureTime frameDescription
Assessment of pressure pain threshold using pressure algometerat baseline and after 4 weeksThe 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.
Assessment of the impact of headache using the Headache Impact Test questionnaireat baseline and after 4 weeksThe 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).
Assessment of Frequency of headacheat baseline and after 4 weeksThe 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

Countries

Egypt

Contacts

Primary ContactNada Gamal Saad, physical therapist
nadagamal004@gmail.com01090415655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026