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.: PACTR201605001650300 Date of Approval: 24/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Normalizing the Cervical Configuration for the Management of Cervicogenic Headaches
Official scientific title The Effect of Normalizing the Sagittal Cervical Configuration for the Management of Cervicogenic Headaches: A 2-Year Pilot Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Although cervical dysfunction from abnormal posture is one factor that has been proposed to aggravate or cause cervicogenic headache, little attention has been afforded to the sagittal cervical posture. Problematically, no experimental studies addressing the role of a normal sagittal cervical configuration in the treatment of cervicogenic headache could be located. Because of limited evidence from good quality randomized controlled trials to support the impact of normalizing the Sagittal Cervical Configuration for the long-term management of cervicogenic headache, the present randomized controlled trial was undertaken to investigate the hypothesis that the addition of the cervical orthotic device, aimed at increasing the cervical lordosis and reducing forward head posture, to a multimodal program consisting of myofascial release, cervical moblization, and therapeutic exercises will have short and long-term improvement effects on cervicogenic headache management outcomes. Up to our knowledge, it is the first study to look at 2-year follow-up.
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 Rehabilitation
Anticipated trial start date 24/05/2008
Actual trial start date 24/05/2008
Anticipated date of last follow up 24/05/2011
Actual Last follow-up date 19/05/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Permuted block randomization (with variable block size 4,6,8) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (with variable block size 4,6,8) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group multimodal program This exercise program was repeated three times per week for 10 weeks. 10 weeks The patients in both groups completed a 10-week multimodal program consisting of myofascial release, cervical mobilization, and therapeutic exercises. 30 Active-Treatment of Control Group
Experimental Group Denneroll extension traction + multimodal program three times per week for 10 weeks 10 weeks In addition to the multimodal programs, the participants in the experimental group also received the denneroll cervical orthotic. The patients were instructed to lie flat on their back and the examiner positioned the apex of the denneroll in one of two regions (mid cervical placement and lower cervical placement) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects were included if the AHT distance was more than 15 mm. their ARA was less than 25°. if they had pain localized to the neck and occipital region and projecting to forehead, orbital region, temples, vertex or ears. limitation of cervical movements. abnormal tenderness on palpation of neck muscles. unilateral headache with no side shift. pain precipitating or aggravating by neck movements or sustained pressure. patients between age group 40-55 years a headache frequency of at least one per week over a period of 2 months to 10 years. Patients with other type of headache like tension headache, migraine. patients who underwent any recent surgery in the neck region. patients with vertebrobasilar insufficiency. patients with side shifting of pain. patients with continuous, unrelieving pain, nocturnal pain. patients with musculoskeletal injuries in the neck. patients with psychological problem and patients with hypo or hyper sensitivity. 40 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 14/04/2008 Research Ethics Committee-Faculty of Physical Therapy-Cairo University
Ethics Committee Address
Street address City Postal code Country
7-Ahmed El zaiat St-ben Elsaryat-El Dokki-Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Modified Von Korff (MVK) pain scale for CGH. All outcome measures were obtained at four intervals: pre-treatment. after 10 weeks of treatment. at one after the intervention period. at two-year after the intervention period.
Secondary Outcome headache frequency, Headache Disability Inventory (HDI), Headache Impact Test-6 (HIT-6), Daily defined dose (DDD) , and cervical sagittal alignment All outcome measures were obtained at four intervals: pre-treatment. after 10 weeks of treatment. at one after the intervention period. at two-year after the intervention period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy-Cairo university 7-ahmed Elziat st.Ben Elsaryat-el Dokki-Giza-Egypt Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CBP Nonprofit (a spine research foundation) 950 E Riverside Eagle, ID 83616 ID United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Moustafa Moustafa 7-Mohamed hassan El gamel st-Nacer City Cairo 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Moustafa Moustafa 7-Mohamed hassan El gamel st-Nacer City Cairo 12612 Egypt
Aliaa A Diab 7-Mohamed hassan El gamel st-Nacer City Cairo 12612 Egypt
Deed E Harrison Eagle,ID,USA Eagle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Moustafa ibrahiem.mostafa@pt.cu.edu.eg 00201227022334 7-Mohamed Hassan El gamel st-Nacer City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor- Basic science departmen,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Deed Harrison drdeed@idealspine.com 1-775-777-3033 123 Second St. Elko, NV 89801
City Postal code Country Position/Affiliation
Eagle 83616ID United States of America doctor of chiropractic 2CBP Nonprofit (a spine research foundation), Eagle, ID, USA
Role Name Email Phone Street address
Scientific Enquiries Aliaa Diab aliaa.atya@pt.cu.edu.eg 0020234596474 7-Mohamed Hassan El gamel st-Nacer City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor- Basic science departmen,Faculty of Physical therapy, Cairo University
REPORTING
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