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.: PACTR202112724901548 Date of Approval: 07/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF CERVICAL STABILITY EXERCISES ON CHRONIC CERVICAL SPONDYLOSIS
Official scientific title EFFECT OF CERVICAL STABILITY EXERCISES IN TREATMENT OF PATIENTS WITH CHRONIC CERVICAL SPONDYLOSIS
Brief summary describing the background and objectives of the trial The principle of cervical stability exercises had gained a wide acceptance in training for the prevention of injury and as a treatment modality for rehabilitation of various cervical disorders, although there have been only few studies investigating the effects of cervical stability exercises in patients with chronic cervical spondylosis. So, this study will conduct to investigate the effect of cervical stability exercises on cervical ROM in treatment of patients with chronic cervical spondylosis. It will be held in outpatient clinic of the faculty of physical therapy, Badr University starting from fourth of December 2021. Forty patients of both genders with age range from 40 to 65 years old diagnose with chronic cervical spondylosis will be recruited and randomly assigned into two equal groups. Group (A) (control group): twenty subjects, will receive the traditional treatment of chronic cervical spondylosis, consisting of hot packs, ultrasound and suboccipital muscles stretch, for 12 sessions. Group (B) (experimental group): twenty subjects, will receive the traditional treatment plus cervical stability exercises for 12 sessions. Cervical stability exercises include strengthening exercises of deep cervical flexors muscles which include chin tucks, isometric holds, ball squeeze, as well as deep cervical extensor muscles which include craniocervical flexion from neutral, upper cervical rotation and extension of cervical spine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/12/2021
Actual trial start date
Anticipated date of last follow up 06/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional treatment Group A 1.hot packs 15 minutes. 2.ultrasound therapy, the head will be used 5 cm2 with parameters of 1MHz frequency, 1.5 W/cm2 Intensity and continuous mode with 100% of duty cycle. Treatment duration will be ten minutes . 3.suboccipital muscles stretch, this exercise will be repeated three times per session with thirty seconds hold then relax for thirty seconds 4 weeks (day after day for 12 sessions) 1.hot packs 15 minutes. 2.ultrasound therapy, the head will be used 5 cm2 with parameters of 1MHz frequency, 1.5 W/cm2 Intensity and continuous mode with 100% of duty cycle. Treatment duration will be ten minutes . 3.suboccipital muscles stretch, this exercise will be repeated three times per session with thirty seconds hold then relax for thirty seconds 20 Active-Treatment of Control Group
Experimental Group cervical stability exercises group Group B 1. the traditional treatment 2. cervical stability exercises 4 weeks (day after day for 12 sessions). the traditional treatment plus cervical stability exercises which include strengthening exercises of deep cervical flexor muscles which included chin tucks, isometric holds, ball squeeze, as well as deep cervical extensor muscles which included craniocervical flexion from neutral, upper cervical rotation and extension of cervical spine. 1. chin tucks is performed from sitting position for three sets of twelve repetitions with holding six seconds each 2. Isometric holds with chin tucks are performed from supine lying position and holding the chin retraction against mattress, with six seconds hold for six repetitions 3. Ball squeeze was performed from sitting position, with the participant holding a small ball between the chin and the chest. The participant was requested to perform isometric contraction for one set, for ten repetitions, ten seconds hold each. the deep cervical extensor muscles strengthening exercises, will be done in quadruped position with cervical, thoracic and lumbar curveswill be kept in their neutral position. 4. craniocervical flexion and return to neutral, the patient will do a head-nodding from neutral position into flexion then back, without rotation in upper cervical region. 5. In upper cervical rotation, the patient will rotate his/her head as if he/she said no. The movement is limited to less than 40°, so that it focuses on craniocervical region especially obliquus capitis superior and obliquus capitis inferior muscles. 6. Extension of lower cervical spine is performed by maintaining the craniocervical region in a neutral position and extending the rest of the cervical spine focusing on the semispinalis cervicis/multifidus muscles. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Both genders will be recruited. 2. Age from 40 to 65 years old . 3. patients will be referred by physician as symptomatic painful chronic cervical spondylosis. 1.Cervical disc prolapse . 2. Any previous cervical injuries or surgeries 3. Temporomandibular disorders that might be contraindication to ball squeeze exercises. 4. Patients performing any neck strengthening or stretching exercises other than the program included in the study 5. Cardiovascular problems that might interfere with performing the exercise program . 6. Any tumor or infection in head and cervical that might be contraindicated to the electrotherapy or exercises treatment. 7. Any peripheral circulatory abnormality e.g., peripheral arterial diseases or deep venous thrombosis that might be contraindicated to perform the exercise program. 8. Patient with life threatening disorders as myocardial infarction, and renal failure might interfere with performing the exercise program. 9. Bone diseases as bone tuberculosis 10. Osteoporosis. Middle Aged: 45 Year(s)-64 Year(s) 40 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 07/02/2021 Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7th Ahmed El-Zayat street in front of Ben El-Sarayat Trafficm Dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Group A cervical range of motion flexion , extension lateral flexions and rotations before and after treatment
Primary Outcome Group B cervical range of motion flexion , extension lateral flexions and rotations Before and after treatment assessment
Secondary Outcome comparison between Group A and Group B cervical Range of motion range of motion comparison
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic. Badr University Entertainment Area, Badr City, Cairo, Egypt. cairo 11829 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shaimaa Mohamed metawee Nasr city , caito , Egypt Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo University 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Amir Saleh amirsalehed@hotmail.com +201006158873 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Amr Shalaby amr.saad@pt.cu.edu.eg +201147718803 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Principal Investigator Shaimaa Metawee shaimaa.motaawa@su.edu.eg +201125648999 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes iam intending to share patient data within 6 months Informed Consent Form 6 months open or controlled
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