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.: PACTR202401838955948 Date of Approval: 16/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of cervical traction on cervicogenic headache in patients with cervical radiculopathy: a randomized controlled trial
Official scientific title Effect of cervical traction on cervicogenic headache in patients with cervical radiculopathy: a randomized controlled trial
Brief summary describing the background and objectives of the trial Cervicogenic headache (CGH) is considered as a secondary headache related to a musculoskeletal neck disorder. It may stem from any cervical spine components (bony, disc and/or soft tissue elements). CGH is frequently encountered in patients with neck pain or cervical radiculopathy (CR). Mechanical cervical traction (CT) is effective on pain and function in patients with CR. We hypothesize that CT might be a effective on CGH. The objective of our study is to evaluate the effect of mechanical intermittent CT on CGH in patients with CR.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CTonCGHinCR
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 01/01/2022
Actual trial start date 13/07/2022
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
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 Group A Mechanical intermittent cervical traction with 2 kilograms The duration of treatment program is four weeks Control group (group A) is treated with conventional rehabilitation program and mechanical intermittent cervical traction (CT). The conventional rehabilitation program comprises cervical spine mobilization, stretching of neck muscles and isometric strengthening exercises. Passive stretching of neck muscles groups is performed in a seated position with 3 repetition of 30 seconds each. Isometric strengthening exercises of neck extensors are performed in a seated position, against the resistance of the physiotherapist hand 3 repetitions of 5 seconds each. Mechanical intermittent CT is performed with 2 kilograms load. The procedure is performed using Saunders device. The Patient is installed in supine position with 20 degrees of cervical flexion and the physiotherapists gradually increases (5 minutes) the load to a maximum of 2 kilograms which is is maintained for 10 minutes then progressively decreases (5 minutes) the load to zero kilograms. The procedure is performed twice with a rest interval of 5 minutes. 12 Placebo
Experimental Group group B Mechanical intermittent cervical traction with 8 kilogram load The duration of the treatment program is four weeks Experimental group (group B) is treated with conventional rehabilitation program and mechanical intermittent cervical traction (CT). The conventional rehabilitation program is the same as described for the control group (group A). The mechanical intermittent CT is performed respecting the same procedure as for the control group (group A) with 8 kilograms load. 12
Experimental Group group C Mechanical intermittent cervical traction with 12 kilogram load The duration of the treatment program is four weeks Experimental group (group C) is treated with conventional rehabilitation program and mechanical intermittent cervical traction (CT). The conventional rehabilitation program is the same as described for the control group (group A). The mechanical intermittent CT is performed respecting the same procedure as for the control group (group A) with 12 kilograms load. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria are: Age between 18 and 65 years, CR diagnosed at least 3 months before enrollment Cervicogenic headache diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria. Exclusion criteria are: Other type of headache (according to ICHD-3 criteria), History of neck or head injury or surgery, peripheral or central neurological diseases, Contraindications for cervical traction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 12/07/2022 The ethical committee of faculty of Medicine of Monastir
Ethics Committee Address
Street address City Postal code Country
Avenue Avicenne, Monastir Monastir 5000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Headache frequency: number of days with headache during the past week. Baseline, 4 weeks, 3 months ,and 6 months
Primary Outcome Headache intensity measured using the visual analogue scale (VAS) graduated from 0 mm (no pain) to 100 mm (worst pain). Baseline, 4 weeks, 3 months, and 6 months
Primary Outcome Medication intake expressed as the quantity in grams of analgesic medication consumed during the past week. baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Cervical radiculopathy pain intensity using the visual analogue scale (VAS) graduated from 0 mm (no pain) to 100 mm (worst pain). baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Patients’ activities of daily living evaluated using the Neck disability index (NDI). It includes 10 items each scored from 0 (no disability) to 5 (total disability). The NDI will be expressed in percentage. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Cervical range of motion (ROM) measured by the Cervical Range-of-Motion Instrument (CROM; Performance Attainment Associates, St Paul, MN). The CROM device is a valid clinical tool with three inclinometers allowing the measurement of active mobility of the cervical spine in flexion, extension, rotation, and lateral flexion. ROMs are expressed in degrees. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Handgrip strength (HGS) measured using the Jamar hydraulic hand dynamometer (Lafayette Instrument Company, USA) and is reported in kilogram. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Cervical muscles strength measured using handheld isometric dynamometer (MicroFET2; Hoggan Health Industries). Measurements will be specified in newton. To assess the strength of the flexor muscles, the dynamometer is placed on the forehead, while for the extensor muscles, it is placed at the back of the head. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome Cervical proprioception testing will be assessed using the CROM device. In sitting position, patients with CROM device in place are asked to keep the head in neutral position (reference position). The examiner asks patients to close their eyes and passively mobilize the head, then the patient return his head to reference position. The examiner records the angle error in degrees. The test is performed for the flexion and the extension. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome The anxiety and depression profile is assessed using the Hospital Anxiety and Depression scale (HAD). It includes 14 items (7 for anxiety and 7 for depression) rated from 0 to 3 each. The maximum score is 21 for both symptoms. Baseline, 4 weeks, 3 months, and 6 months
Secondary Outcome The participants’ quality of life is assessed using the World Health Organization quality of life (WHOQOL-bref) questionnaire with 4 domains: physical health, psychological, social relationships, and environment. Each domain is reported in percentages. Baseline, 4 weeks, 3months, and 6 months
Secondary Outcome To evaluate the fear of movement the Tampa Scale for kinesiophobia (TSK) is used. It includes 17 items rated from 1 to 4 each, with a total score range from 17 to 68. Higher scores reflect greater levels of movement-related fear. Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fattouma Bourguiba university hospital Departments of Physical Medicine and Rehabilitation and Rheumatology Avenue Farhat HACHED Monastir 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding sourses not applicable not applicable Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anis Jellad Monastir Monastir 5000 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Chaabeni amrch97@gmail.com 21626729316 avenue Avicienne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia physical medicine and rehabilitation department
Role Name Email Phone Street address
Principal Investigator Anis Jellad anisjellad@gmail.com 21698210626 avenue Avicienne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia physical medicine and rehabilitation department
Role Name Email Phone Street address
Public Enquiries Amine Kalai amine.kalai.1@gmail.com +21697978780 avenue Avicienne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia University of Monastir
Role Name Email Phone Street address
Scientific Enquiries Cyrine Ben Nasrallah Cyrine.bennasrallah@gmail.com +21621240245 rue 3 aout
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia University of Monastir
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. In addition, the protocol and the statistical analysis plan will be shared from 6 months following the publication without end date. individuals and organizations who are engaged in scientific or scholarly research can request this details from Professor Anis Jellad (anisjellad@gmail.com) to achieve aims in the approved proposal. Statistical Analysis Plan,Study Protocol As part of our IPD sharing plan, we will make the data collected in the study available in the protocol. Once the data collection phase is complete, interested researchers will have access to the raw, unprocessed data through the provided protocol. Additionally, we will share the statistical details related to the data analysis. However, to ensure the timely publication and dissemination of our research findings, the statistical details will be shared six months after the research has been published. Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to professor Anis Jellad (anisjellad@gmail.com). The request should include the purpose of the data usage, a detailed description of the proposed analyses, and any specific requirements. the request will be evaluated to assess the qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. The documents, including study protocols, statistical details, and other relevant materials, will be made available as agreed upon.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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