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.: PACTR202209582455927 Date of Approval: 19/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CERVICAL STABILITY EXERCISES ON CERVICAL RADICULOPATHY.
Official scientific title EFFECT OF CERVICAL STABILITY EXERCISES ON MYOELECTRIC ACTIVITIES IN PATIENTS WITH CERVICAL RADICULOPATHY. “A RANDOMIZED CONTROLLED TRIAL”
Brief summary describing the background and objectives of the trial Cervical stability training program will be conducted in order to improve cervical spine stability, decrease pain, increase strength and improve functionality. Cervical radiculopathy, as a result of disc herniation or cervical spondylosis causes pain, sensory and motor deficits, and though this study will be conducted to investigate the effect of cervical stability exercises on pain, neck functional abilities, electromyography for flexors and extensors, and nerve conduction velocity for median nerve in treatment of patients with cervical radiculopathy. It will be held in outpatient clinic of El Qsr Einy teaching hospital from 15 January 2022. Twenty patients of both gender with age ranged from 25 to 55 years old diagnosed as cervical radiculopathy will be randomly assigned into two equal groups. Group (A) (control group) ten patients will receive conventional treatment of cervical radiculopathy which consists of hot packs, ultrasound therapy Transcutaneous electrical nerve stimulation and sub-occipital muscles stretch for twelve sessions. Group (B) (Experimental group) ten patients will receive conventional treatment of cervical radiculopathy in addition to cervical stability exercises which consists of strengthening of deep cervical flexors muscles including ball squeeze, chin tuck and isometric holds , and strengthening of deep cervical extensor muscles including cervical spine extension, upper cervical rotations and cranio-cervical flexion from neutral. assessment will be done before and after comleting 12 sessions by numerical rating scale, neck disability index, electromyography and nerve conduction velocity.
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 11/09/2022
Actual trial start date
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
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 Group A 12 sessions day after day for 4 weeks 1- hot packs 15 minutes 2- ultrasound 10 minutes 1MHZ, 1.5Watt/cm2 continuous mode 3- Transcutaneous electrical nerve stimulation for 20 minutes 4- suboccpital stretch hold 30 seconds and repeat 3 times 4 weeks (12 sessions day after day) 1- hot packs 15 minutes 2- ultrasound 10 minutes 1MHZ, 1.5Watt/cm2 continuous mode 3- Transcutaneous electrical nerve stimulation for 20 minutes 4- suboccpital stretch hold 30 seconds and repeat 3 times 10 Active-Treatment of Control Group
Experimental Group Group B 12 sessions day after day 1- hot packs 15 minutes 2- ultrasound 10 minutes 1MHZ, 1.5Watt/cm2 continuous mode 3- Transcutaneous electrical nerve stimulation for 20 minutes 4- suboccpital stretch hold 30 seconds and repeat 3 times 5- cervical stability exercises 4 weeks (12 sessions day after day) the traditional treatment plus cervical stability exercises A- the traditional treatment or the same as group A B- 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, 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. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- 20 patients with cervical radiculopathy will be recruited from Al Qsr Einy teatching hospital 2- Age w25- 55 years 3- both gender 4- referring from the orthopedist as cervical radiculopathy. 1- any previous cervical injuries or surgeries traumas and infection . 2- Temporomandibular disorders that might be contraindication to ball squeeze exercises 3-Patients performing any neck strengthening or stretching exercises other than the program included in the study 4-Cardiovascular problems that might interfere with performing the exercise program 5- Any tumor or infection in head and cervical that might be contraindicated to the electrotherapy or exercises treatment 6- Any peripheral circulatory abnormality e.g., peripheral arterial diseases or deep venous thrombosis that might be contraindicated to perform the exercise program. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 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 04/01/2022 research ethical committee faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7th Ahmed El-Zayat street in front of Ben El-Sarayat Trafficm Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Group A 1- pain intensity 2- functional scale 3- electromyoghraphy 4- nerve conduction velocity Group A pre- post treatment assessment
Primary Outcome Group B 1- pain intensity 2- functional scale 3- electromyoghraphy 4- nerve conduction velocity pre and post treatment assessment
Secondary Outcome comparison between both groups in 1- pain intensity 2- functional scale 3- electromyoghraphy 4- nerve conduction velocity comparison between both groups
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Qasr Einy Hospital 71 El Kasr El Aini Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
shaimaa metawee 1 madfayaa , Nasr city Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sinai University El Qantara Branch El Qantara El Sharqiya, Ismailia Governorate Ismailia 41636 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Metawee shaimaa.motaawa@su.edu.eg +201125648999 1 madfayaa Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Haitham ElHafez haitham.elhafiz@pt.cu.edu.eg +201001909630 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate
City Postal code Country Position/Affiliation
Giza 11432 Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries shaimaa Metawee shaimaa.motaawa@su.edu.eg 00201125648999 makram ebead
City Postal code Country Position/Affiliation
nasr city cairo 11765 Egypt lecturer basic science department faculty of physical therapy sinai university egypt
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 identification Study Protocol Immediately after publication, no end date open or controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be added later 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