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

November 25, 2024 updated by: Nada Gamal Saad, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • out-patient clinic, national institute of neuromotor system, Egypt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
at baseline and after 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of pressure pain threshold using pressure algometer
Time Frame: at baseline and after 4 weeks
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
Time Frame: at baseline and after 4 weeks
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
Time Frame: at baseline and after 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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