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.: PACTR201701001972227 Date of Approval: 15/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cognitive Behavioral Therapy in Mangement of Chronic Cervical Radiculopathy
Official scientific title Effect of Cognitive Behavioral Therapy in Management of Chronic Cervical Radiculopathy
Brief summary describing the background and objectives of the trial Patients with CR suffer from prolonged functional impairments due to chronic pain, associated activity limitations, long periods of sick leave, and difficulties in returning to work. Chronic pain usually accompanied by pain anxiety that influence treatment outcomes. Pain anxiety is a complex response comprised of fear (emotional), cognition (verbal behavior), physiological anxiety (sensations), and escape/avoidance behavior, which results in physical and psychological stresses. Although a definitive progression for treating CR has not been developed, a consensus exists within the literature that there is no high quality evidence for stand-alone treatment; however using manual therapy techniques in conjunction with therapeutic exercises is the most effective treatment in improving function, quality of life, while decreasing levels of pain and disability. Cognitive-behavioral therapy (CBT) is a technique that include a wide set of interventions conducted by health professionals such as psychologists, physiotherapists, and rehabilitative teams. It includes modifications of specific activities to reduce the impact of psychological stress and to overcome dangerous barriers to physical and psychosocial recovery. CR must be managed with caution regarding history, physical examination and management strategies. Cognitive behavioral management along with manual therapy and a structured exercise program appear to be the hallmark treatments for radicular pain, which will be beneficial over a lifetime. As a result, highly effective management of chronic pain is still not available. The results of the currently best possible chronic pain treatments, such as pharmacological treatment, multimodal rehabilitation, physical exercise, and psychological treatment primarily cognitive behavioural therapy have in general been weak to moderate Consequently, it will be of importance to investigate the effect of adding CBT to conventional treatment on chronic CR.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cervical radiculopathy,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/02/2017
Actual trial start date 05/02/2017
Anticipated date of last follow up 05/02/2018
Actual Last follow-up date 05/02/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group cervical mobilization and core strengthening exercises mobilization with a progressive increase of force to grade IV for 30 seconds or 15¿20 repetitions at each desired level and exercises for three sets per session, each set consist of 10 repetitions 3 sessions/week for 6 consecutive weeks for total of 18 sessions a) Cervical Postero-Anterior Central Vertebral Mobilization, b) Cervical Retraction Mobilization, c) Cervical Rotation Mobilization, d) Cervical lateral glides e) Deep neck flexor strengthening f) Scapulothoracic exercises: Lower and middle trapezius and serratus anterior strengthening 30 Active-Treatment of Control Group
Experimental Group cervical mobilization, core strengthening exercises, and cognitive behavioral therapy mobilization with a progressive increase of force to grade IV for 30 seconds or 15¿20 repetitions, exercises for 3 sets per session of 10 repetitions, and 20 minutes of CBT 3 sessions/week for 6 consecutive weeks for total of 18 sessions the same as control plus CBT: a) cognitive: Education on the basic physiology of chronic pain, anatomy of the cervical region, and Physiologic and biomechanical bases of motor behavior b) operant Gradual progression of cervical movements and low-intensity aerobic exercise c) respondent part: Auto traction techniques,muscle relaxation techniques, self stretching, and Diaphragmatic breathing 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
CR due to spondylotic changes or bony spur formation. Patients have a unilateral C5-6 or C6-7, cervical spondylosis confirmed by imaging (computed tomography and/or magnetic resonance imaging). C6 or C7 dermatomal numbness, current continuous or intermittent pain or discomfort which has persisted for more than 3 months, diminished deep tendon reflexes in the affected arm, and no spinal deformity according to cervical spine derangement classifications. At least 3 positive tests of the clinical prediction rules which included the presence of four positive examination findings (Spurling test, upper limb tension test, cervical distraction test, and less than 60° cervical rotation towards the symptomatic side). Previous fracture or subluxation of the cervical spine, malignity, spinal tumour, spinal infection, previous surgery in the cervical spine. Drug abuse and diagnosed psychiatric disease. cognitive impairment (deficits in higher reasoning, forgetfulness, learning disabilities, concentration difficulties, decreased intelligence and other reductions in mental functions). Any signs or symptoms of medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use). A history of previous cervical or thoracic spine surgery, signs or symptoms of upper motor neuron disease, vestibulobasilar insufficiency, amyotrophic lateral sclerosis, and myelopathy. Bilateral upper extremity radicular symptoms. The complete loss of sensation along the involved nerve root. 45 Year(s) 65 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 01/02/2017 faculty of physical therapy research ethical committe
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayad, Dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Pain anxiety symptom scale (PASS) Arabic version Before the treatment After the treatment 12 months after the treatment
Secondary Outcome Pain level and Functional status: Neck Disability Index (NDI) Arabic version Before the treatment After the treatment 12 months after the treatment
Secondary Outcome Cervical Active Range of Motion: measurements of flexion, extension, lateral flexion, and rotation will be taken with the subject in sitting position using a universal inclinometer placed on top of the subject¿s head Before the treatment After the treatment 12 months after the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Faculty of Physical Therapy 7 Ahmed Elzayad, Dokki Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
own financial resources 135 L Hadayek Alahram Giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 ahmed elzayat st eldokki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed marzouk mohamed 7 Ahmed Elzayat, Dokki Giza 12613 Egypt
neveen abd ellatif abd elraoof 7 Ahmed Elzayat, Dokki Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Marzouk Mohamed Ragab Mohamed.ragab@cu.edu.eg +20 01016111412 Magd Tewfik St. - 135L ¿ 4th Gate- Hadayek Al-Ahram
City Postal code Country Position/Affiliation
Giza 12522 Egypt Assistant Lecturer at Basic Science Department, Faculty of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Salah Eldin Basst Ahmed utcsalah@cu.edu.eg +20 01020233023 22 Amr St. - Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Lecturer at Basic Science Department, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Neveen Abdel-Latif Abdel Raoof dr_neveen_69@cu.edu.eg +20 01064615553 10 Morad St. ¿ Faisl
City Postal code Country Position/Affiliation
Giza 12511 Egypt Professor at Basic Science Department, Faculty of Physical Therapy, Cairo University
REPORTING
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