Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911525390567 Date of Approval: 11/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Graston Technique on Cervicogenic Headache
Official scientific title Effect of Graston Technique on Cervicogenic Headache: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The International Headache Society has classified the cervicogenic headache as a secondary headache type that is hypothesized to originate due to nociception in the cervical area. It has been mostly related to joint, disc and ligament disease of the upper cervical spine. It was found that manual therapies targeted to either muscle or joints of the upper cervical spine might be an effective treatment for Cervicogenic headache ,Also treatment of sternocleidomastoid muscle trigger points have a positive effect on headache intensity in cervicogenic cases Graston Technique is an instrument assisted soft tissue mobilization (IASTM) that seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis and efficiently mobilize and stimulate the resorption of soft-tissue fibrosis thought to be the underlying cause in many joint and connective-tissue dysfunctions. This study will be conducted to investigate the effect of using Graston technique as instrument assisted soft tissue mobilization technique on pain intensity, headache and neck disability and cervical range of motion in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/05/2019
Actual trial start date 05/06/2019
Anticipated date of last follow up 05/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy exercise program 3 sessions per week for 4 weeks Four weeks -Stretching exercises for the sternocleidomastoids (SCM), the scalenes and upper fibers of trapezius. Static stretching is done for 15 to 30 seconds and 2 to 4 repetitions -Strengthening isometric exercises for the neck flexors ,extensors, lateral flexors ,neck rotators. Hold for 10 seconds. Relax. Repeat 5 times. -Postural correction exercises. The postural correction exercises consisted of cervical retraction exercises, upper cervical nodding exercises, and scapular retraction exercises. Hold for 5 second repeat 20 to 30 times. 30 Active-Treatment of Control Group
Experimental Group Graston technique and conventional physical therapy exercise program 3 sessions per week for 4 weeks 4 weeks Graston technique will be applied in combination with the same exercise program of control group. The appropriate Graston Technique instruments will be selected to scan, then treat, the affected area. • Treatment time is usually 30 to 60 seconds per area treated • It is common for patients to experience some discomfort during the procedure. • The procedure will be applied on Superficial Cervical Fascia and investing layer of deep cervical fascia that surrounds all the structures in the neck. Where it meets the trapezius and sternocleidomastoid muscles, it splits into two, surrounding them beginning from upper attachment in the external occipital protuberance and the superior nuchal line of the skull. In addition, posteriorly along the nuchal ligament of the vertebral column. • Strokes will be also applied on sternocleidomastoids (SCM), the scalenes and upper fibers of trapezius muscles. • Treatment will be applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle, followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for an additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. • Patients will be advised that they may be sore, bruised or exhibit small red dots over the area treated, called petechiae. • If any soreness is felt after the procedure, ice application for 15 to 20 minutes following the treatment may ease the discomfort 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 35-50 years of both genders – Patients will be selected according to international headache society classification of cervicogenic headache and Patients had to exhibit to the following criteria :  Unilaterality of the head pain without side shift, starting in the upper posterior neck or occipital region, eventually spreading to the oculofrontotemporal area on the symptomatic side.  Pain triggered by neck movement and/or sustained awkward positions.  Reduced range of motion in the cervical spine.  Pain elicited by external pressure over at least one of the upper cervical joints.  Moderate to severe, non-throbbing and non-lancinating pain.  Participants had to have a headache frequency of at least 1 per week for a minimum of 3 months, a minimum disability score of 20 % or greater (i.e., 10 points or greater on the 0–50 NDI scale). Patients will be excluded if  They exhibited other primary headaches (i.e., migraine, Tension type headache)  Suffered from bilateral headaches.  Exhibited any red flags (i.e., tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use.  Diagnosed of cervical spinal stenosis  Diminished sensation  Have an evidence of central nervous system involvement.  Have a history of whiplash injury within the previous 6 weeks, had prior surgery to the head or neck, had received treatment for head or neck pain from any practitioner within the previous month  Have received physical therapy approache for head or neck pain within the previous 3 months.  Open wounds.  Psychiatric or cognitive disorders.  Patients contraindicated to carotid artery massage (CSM) as history of (Myocardial infarct, transient ischaemic attack, or stroke in the 3 months prior to attendance are absolute contraindications. Others include a history of ventricular fibrillation or ventricular tachycardia and a history of previous adverse reaction to CSM) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/05/2019 Ethics committee of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Cervical range of motion before treatment program , after 6 sessions and at the end of program
Secondary Outcome Neck disability index before treatment program , after 6 sessions and at the end of program
Primary Outcome visual analogue scale before treatment program , after 6 sessions and at the end of program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tala General Hospital Tala-Babel road Tala 32611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Abd Elgawad Megahed 10 shahid gouda st tala 32611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr.Nabil Mahmoud Abdel Aal 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza, Faculty of physical Therapy Giza 12613 Egypt
Prof.Dr.Mohsen Mohamed ElSayyad 7 Ahmed Elzayat st. BienElsarayat, Dokky, Giza, Faculty of physical therapy Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohsen El Sayyad Dr_sayyad1@hotmail.com +201019661445 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza ,Faculty of Physical therapy
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Physical therapy
Role Name Email Phone Street address
Principal Investigator Nabil Abdel Aal Nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza, Faculty of physical Therapy
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries Nabil Abdel Aal Nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza, Faculty of Physical Therapy
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Nabil Abdel Aal Nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza, Faculty of physical therapy
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in the article after identification including text,tables,figures and appendices Statistical Analysis Plan,Study Protocol 6 months following publication anyone wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information