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.: PACTR202306534674849 Date of Approval: 20/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Physical Therapy Program On Cervical Radiculopathy In The Reversed Cervical Curve Patients: A Randomized Trial WIth 1-Year Follow-Up
Official scientific title Effect Of Physical Therapy Program On Cervical Radiculopathy In The Reversed Cervical Curve Patients: A Randomized Trial WIth 1-Year Follow-Up
Brief summary describing the background and objectives of the trial cervical radiculopathy due to reversed cervical curve is a widespread problem in the present time. this problem affect on patient in all ages due to the long time spent in the front of screens (computers and smart phones). Cervical radiculopathy is the neurogenic symptoms combined with cervical nerve root compression or inflammation. The reversed curve describes the position of deficient front-to-back spinal curvature in the neck resulting in nerve root impingement can result from foraminal narrowing leading to radiculopathy. so we apply this study to evalute the physical therapy as option for treatment of cervical radiculopathy associated with reversed cervical curve patients.
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 11/10/2022
Actual trial start date 15/12/2022
Anticipated date of last follow up 12/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not 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 randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group medical treatment - Non Steroidal Anti-inflammatory Druds (3times/day for one month) - Muscle relaxant tablets ( one tab at night for a month) - Vitamin B supplement (ampoule / 3 day for 3 month) - Semi-hard cervical collar (applied all time except sleeping time for 6-12 weeks) 3 MONTHS - Non Steroidal Anti-inflammatory Druds (3times/day for one month) - Muscle relaxant tablets ( one tab at night for a month) - Vitamin B supplement (ampoule / 3 day for 3 month) - Semi-hard cervical collar (applied all time except sleeping time for 6-12 weeks) 30 Active-Treatment of Control Group
Experimental Group PHYSICAL THERAPY PROGRAM and medical treatment 1- Medical treatment as follow: - - NSAIDs (3times/day for one month) - Muscle relaxant ( one tab at night for a month) - Vitamin B supplement (ampoule / 3 day for 2 month) - Semi-hard cervical collar (applied all time except sleeping time) 2- physical therapy : 3 sessions/week for 3 months 3 months 1- Medical treatment as follow: - - NSAIDs (3times/day for one month) - Muscle relaxant ( one tab at night for a month) - Vitamin B supplement (ampoule / 3 day for 2 month) - Semi-hard cervical collar (applied all time except sleeping time) 2- Physical therapy program: • Manual therapy: consists of deep relaxed massage for 10 minutes, suboccipital muscle friction massage for 5-10 minutes (patient lies pre-skin in a prone lying position, put anti-inflammatory cream, applies massage), and suboccipital myofascial release (patients lay down in supine with knee flexion, The therapist sat on a stool at the head of the table, his Elbows and supinated forearms were on the table, The subjects were asked to lift their head off the table, then the first three fingers tips of the therapist applied into the soft tissue immediately inferior to the arc of atlas, The subjects were asked to rest their head back down so that their fingertips are in the sub-occipital soft tissues and their finger pads rest firmly against the inferior aspect of the atlas then apply minimal soft tissue traction). Cervical mobilization (The patient sat on a stool and the therapist was standing behind him put his thumbs on the facet joint at an angle of 45 degrees upwards and moved the patient head down and up with a repetition of 5-10 times at the level of each vertebra. • Stretching exercises: Patients were asked to sit on the stool with relaxed shoulders, the therapist stood behind the patient, then apply the stretching exercises for the upper fibers of the trapezius, levator scapula, scalenus, sternocleidomastoid, pectoralis, and suboccipital muscles on both sides with holding stretch force 15-30 seconds and relax for 15 seconds and repeat the exercise 10 times for each muscle. - strenghthening exercises for scapular retractors, dpressors, serratus anterior and deep neck flexors (10 repeation/ set for 5 sets with 5 seconds rest in between) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
UNILATERAL RADICLUPATHY REVERSED CERVICAL CURVE CENTERAL SPINAL CANAL STENOSIS VESTIBULAR INSUFFICIENCY RHEUMATOID ARTHRITIS OSTEOPROSIS THORACIC OUTLET SYNDROM Adult: 19 Year-44 Year 19 Year(s) 44 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 15/12/2022 physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
south valley university Qena 83523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analog scale VAS before, 3months, 1 year
Primary Outcome X RAY absolute rotation angle ARA BEFORE, AFTER 3 MONTS, AFTER 1YEAR
Secondary Outcome cervical ROM for side bending and rotayion before, after 3 months, after 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy and rehabilitation center faculty of physical therapy south valley university Qena 83523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self south valley university Qena 83523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor south valley university south valley university Qena 83523 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elshazly mahmoud.elshazly311@svu.edu.eg 0021019732833 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt assistance professor of physical therapy foe surgery
Role Name Email Phone Street address
Public Enquiries abdelrzak ahmed dr_abdelrazak_pt@yahoo.com 0021063267068 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt lecturer of physical therapy for neurological disorders
Role Name Email Phone Street address
Scientific Enquiries Amany Ibrahim amanyabbaspt4@gmail.com 0021112986727 south valley university
City Postal code Country Position/Affiliation
Qena 83523 Egypt lecturer of physical therapy for musculoskeletal disorders
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately following publication anyone who 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