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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tension-Type Headache; Suboccipital Release; Instrumental Assisted Soft Tissue Mobilization
• Intervention / Treatment: Other: conventional physical therapy program; Other: Suboccipital release; Other: Instrument Assisted soft tissue mobilization

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Gamal Saad, physical therapist; Phone Number: 01090415655; Email: nadagamal004@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • out-patient clinic, national institute of neuromotor system, Egypt
    • Contact: Nada Gamal Saad, physical therapist; Phone Number: 01090415655; Email: nadagamal004@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional program; Twenty patients will receive conventional physical therapy including Hot pack and exercise therapy program (ROM exercise, stretching exercise, isometric strengthening exercise for cervical muscles	Other: conventional 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.
Experimental: suboccipital release; Twenty patients will receive suboccipital release plus the Same conventional physical therapy program.	Other: conventional 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.; Other: Suboccipital release; 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.
Experimental: instrumental assisted soft tissue mobilization; Twenty patients will receive instrumental assisted soft tissue mobilization plus the Sam conventional physical therapy program.	Other: conventional 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.; Other: Instrument 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	at baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: Nada-005491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No