Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201706002316214 Date of Approval: 23/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Upper cervical manual traction in the management of cervicogenic headache
Official scientific title Effect of Mulligan upper cervical manual traction in the treatment of cervicogenic headache: A pilot randomized controlled trial
Brief summary describing the background and objectives of the trial In the treatment of cervicogenic headache; neither medications have been documented to be effective nor facet joint injections. The significant effects of using Mulligan manual cervical traction in the treatment of cervical pain and radiculopathy were documented. It reduces the impingement of the cervical facet joints which relieves sensitized cervical tissues. This study is designed to address the significance of Mulligan upper cervical manual traction to decrease headache pain intensity and improve functional level in patients with cervicogenic headache. Up to our knowledge, this is the first RCT that investigates the effect of Mulligan upper cervical manual traction in the management of cervicogenic headache
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cervicogenic headache,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/001561 Research Ethical Committee- Faculty of Physical Therapy- Cairo University
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(variable block size 4, 6) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization(variable block size 4, 6) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization(variable block size 4, 6) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multi-modal program and Mulligan upper cervical manual traction. Repeated 3 time per week for 3 weeks 3 weeks Hot packs, TENS, and deep cervical flexors strengthening exercises, Upper cervical manual traction is applied. The traction force is maintained for 10 second and repeated for 10 times every session 15
Control Group Multi-modal program Repeated 3 times per week for 3 weeks 3 weeks Hot packs, TENS, and deep cervical flexors strengthening exercises are applied every session. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Headache frequency of at least once per week over a period of 3 months. FRT reveals 10-degree loss to the painful side will be considered positive finding and indication for cervicogenic headache. Tenderness of neck muscles. A unilateral headache without side shift. Pain aggravated by neck motions or pressure over the upper cervical facet joints. Patients who had surgical intervention in the cervical spine or spinal tumors. Patient with pain or dysfunctions in the temporo-mandibular joint. Headaches associated with high fever, stiff neck, or rash. Patients with psychological problems, Patients with vision problems or profound dizziness. 30 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 12/02/2017 Research Ethical Committee-Faculty of Physical Therapy- Cairo University
Ethics Committee Address
Street address City Postal code Country
7-Ahmed Elziat st. Ben Elsaryat-el Dokki-Giza-Egypt Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Headache intenisty as measured by Numeric Pain Rating Scale(NPRS) All outcome measures are and will be obtained at three intervals: pre-treatment, after three weeks, and three months after the intervention period.
Secondary Outcome Headache frequency, headache duration, disability as measured by the Neck Disability Index(Arabic version), and medication intake. All outcome measures are and will be obtained at three intervals: pre-treatment, after three weeks, and three months after the intervention period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Ahrar teaching hospital Al-Ahrar street Al-Zagazig Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al-Ahrar teaching hospital Al-Ahrar street Al-Zagazig Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al-Ahrar teaching hospital Al-Ahrar street Al-Zagazig Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Salwa Fadl Abdelmajeed 7-Ahmed El zaiat st, Ben Elsaryat- El Dokki-Giza Giza 12612 Egypt
Hamed Mohamed Elkhozamy 7-Ahmed El zaiat st, Ben Elsaryat- El Dokki-Giza Giza 12612 Egypt
Mohamed Abdelmonem Abdelgayed Khalil Twafiq Abaza st. Al-Zagazig Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Khalil makhalil@utica.edu 00201116778442 Tawfiq Abaza st.
City Postal code Country Position/Affiliation
Al-Zagazig Egypt Consultant orthopedic physical therapist- Alahrar teaching hospital.
Role Name Email Phone Street address
Public Enquiries Hamed Elkhozamy h_khozamy@yahoo.com 00201151159422 7-Ahmed El zaiat st. Ben Elsaryat- El Dokki- Faculty of physical therapy
City Postal code Country Position/Affiliation
Giza 12612 Egypt Lecturer of physical therapy- Orthopedic physical therapy department
Role Name Email Phone Street address
Scientific Enquiries Salwa Abdelmajeed dr_salwa_fadl@live.com 00201008565476 7-Ahmed El zaiat st. Ben Elsaryat- El Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Professor of orthopedic physical therapy. Faculty of physical therapy. Cairo university
REPORTING
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