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

NCT06703385 | Not Yet Recruiting

• 1 other identifier: Nada-005491
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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)

  at baseline and after 4 weeks

Secondary Outcomes (3)

• Assessment of pressure pain threshold using pressure algometer

  at baseline and after 4 weeks

• Assessment of the impact of headache using the Headache Impact Test questionnaire

  at baseline and after 4 weeks

• Assessment of Frequency of headache

  at baseline and after 4 weeks

Study Arms (3)

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

Other: conventional physical therapy program

suboccipital release

EXPERIMENTAL

Twenty patients will receive suboccipital release plus the Same conventional physical therapy program.

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.

Other: Instrument Assisted soft tissue mobilization; Other: conventional physical therapy program

Interventions

Instrument Assisted soft tissue mobilization OTHER

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.

instrumental assisted soft tissue mobilization

Suboccipital release OTHER

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.

suboccipital release

conventional physical therapy program OTHER

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.

conventional program; instrumental assisted soft tissue mobilization; suboccipital release

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

out-patient clinic, national institute of neuromotor system, Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Nada Gamal Saad, physical therapist

CONTACT

01090415655; nadagamal004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)