Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Instrument Assisted soft tissue mobilization
Other interventionThe 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 release
Other interventionThe 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 program
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: conventional programActive comparator 1 intervention
Group B: suboccipital releaseExperimental treatment 2 interventions
Group C: instrumental assisted soft tissue mobilizationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
at baseline and after 4 weeksSecondary outcomes
1
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.
Time frame
at baseline and after 4 weeks2
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).
Time frame
at baseline and after 4 weeks3
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
Time frame
at baseline and after 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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