Hamstring Active Release Technique in Cervicogenic Headache

April 7, 2023 updated by: Samar Ahmed El Sayed Mohammed, Cairo University

Effect of Hamstring Active Release Technique in Cervicogenic Headache

It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.

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

Cervicogenic Headache (CGH) is a secondary and often unilateral headache that is known by referring pain from soft or hard cervical structures to occipital, temporal and frontal regions. There are some fascial connections between suboccipital muscles with dura mater and C2 vertebra. Presumably, fascial restriction in one part of the body causes unusual stress in other parts of the body due to fascial continuity. It has demonstrated that increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. This occurs because the superficial fascial back line of the myofascial chain connects from the neck to the lower extremity, and the soft tissue in the cervical spine links the dura and suboccipital muscle fascia. Therefore, it is probable that if the tone of the hamstring muscles is decreased (passively, with a fascial treatment or with active movements), the tone of the knee flexors (hamstring muscles) is reduced and the amplitude of hip flexion is increased, thereby increasing the straight leg raise (SLR) test score. Active release technique (ART) is a type of manual therapy used for treating soft tissue injuries. Problems with muscles, tendons, ligaments, fascia and nerves are successfully treated with it and is found to have an effect on hamstring flexibility.

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 (Anticipated)

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 Contact Backup

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months.
  • Pain and tenderness at the upper cervical segment's palpation.
  • Movement restriction in cervical region, especially in the upper cervical rotation.
  • Positive SLR test for hamstring muscle less than 80◦.

Exclusion Criteria:

  • Malignancy.
  • Other types of headaches, including migraine, tension type, other serious headaches.
  • History of head and neck trauma or surgery.
  • Pregnancy.
  • Physiotherapy for headache in the last 3 months.

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: 1- control group
conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise)
Other: conventional therapy
ultrasound therapy - stretching Exercise - Strengthening Exercise -
Experimental: 2- Experimental group
Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise)
Other: conventional therapy
ultrasound therapy - stretching Exercise - Strengthening Exercise -
Other: active release technique
Hamstring active release technique-

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
Assess the change in pain intensity level
Time Frame: Before treatment and after 4 weeks treatment
The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in rehabilitation.VAS is typically composed of a 100 mm horizontal line attached with two opposed labels, the left end marked "no pain" and the right end "severe intolerable pain".Patients will mark a score on the scale by a vertical line.
Before treatment and after 4 weeks treatment
Assess the change in headache severity
Time Frame: Before treatment and after 4 weeks treatment
The headache impact test (HIT-6) : is a tool that subjectively evaluates the frequency of a patient's headache. The lowest score is 36, and the highest score is 78 for six items.Usually, if the score is over 59, it means the patient's daily life is severely affected by the headache.
Before treatment and after 4 weeks treatment
Assess the change in pressure pain threshold
Time Frame: Before treatment and after 4 weeks treatment
Pressure algometry will be used to evaluate the (PPT) for suboccipital and hamstring muscles.In the prone position, the physician will apply 1 kg/s of pressure directly to suboccipital and hamstring muscles, the participant will speak up at the point where the pressure evoke a painful sensation, and the instantaneous value will be recorded as the PPT.
Before treatment and after 4 weeks treatment

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
Assess the change in Cervical flexion rotation test
Time Frame: Before treatment and after 4 weeks treatment
By the cervical range of motion (CROM) instrument placed on the head.The evaluator will perform maximum flexion of the cervical spine followed by a rotation to each side.Each measurement will be repeated 3 times at 30 s intervals. The mean value obtained from the 3 trials will be used for data analysis. The reported normal range of rotation during the CFRT is 44° to each side. A test will be reported as positive when individuals demonstrate a reduction of movement of 10◦ compared to the normal range of motion (<34◦).
Before treatment and after 4 weeks treatment
Assess the change in Hamstrings flexibility
Time Frame: Before treatment and after 4 weeks treatment
By Straight leg raising test (SLR) to assess Hamstrings flexibility.The participant will be placed in a supine position, his calcaneus will be held with one hand and the leg will be lifted, and the other hand will be fixed so that the patient's knee is not flexed.
Before treatment and after 4 weeks treatment

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wadida H Elsayed, Professor, Cairo University
  • Study Director: Ghada A Mousa, Ass.prof, Cairo University
  • Study Director: Hanaa K Atta, Lecturer, Cairo University
  • Study Director: Nabil H El Agooz, Professor, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

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.
April 1, 2023

Primary Completion (Anticipated)

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.
June 1, 2023

Study Completion (Anticipated)

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.
July 1, 2023

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).
December 12, 2022

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.
December 20, 2022

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.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

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.
April 10, 2023

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.
April 7, 2023

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.
April 1, 2023

More Information

Terms related to this study

Keywords

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.
  • P.T.REC/012/003916

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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