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.: PACTR202007880609645 Date of Approval: 21/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of pilates mat exercise on myoelectric activity of cervical muscles in patient with chronic mechanical neck pain
Official scientific title effect of pilates mat exercise.on myoelectric activity of cervical muscles,pain and function in patient with chronic mechanical neck pain
Brief summary describing the background and objectives of the trial Neck pain is a common condition, affecting about 70% of people at some time in their lives. (Cagnie et al., 2007; Falla et al., 2012), International epidemiological data shows that prevalence of neck pain is approximately 40%, varying from 17% to 75%. (Fejeret al., 2006), Individual with neck pain who lack an identifiable pathanatomical cause for their syptoms are usually classified as having mechanical neck pain. Direct pathoanatomical cause of mechanical neck pain is rarely identifiable.(Heintz et al., 2010).Pilate's method is a physical fitness system that was developed during the First World War in the early 20th century by Joseph Hubertus Pilates. Direction Control and Range Control exercises are two key types of specific exercises that should be used when specific uncontrolled movements are found. (Kuo et al., 2009) Pilates aims to attain balance between the stabilizing muscles anchoring one body region (Direction Control) while the muscles moving an adjacent joint or region, work efficiently to move from one extreme of range (sometimes hyper-mobile) to the other and back again (Range Control).Stability, Mobility and Agility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CMNP
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/09/2020
Actual trial start date 10/09/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pilates mat exercise and conventional therapy 3times/week 12 weeks Hip twist level 1: active starting position: supine one knee moves away from and then towards midline of the body while maintaining a neutral position of spine. This challenges the rotational control of the lumbar spine Double leg stretch level 1: Both the Arms are lowered overhead while maintaining ribcage and pelvic control Double leg stretch level 2: As for level 1 but simultaneously sliding one heel along the mat away from the body One leg stretch level 1: one heel slides along mat extending same leg without allowing the pelvis to anteriorly tilt. Clam level 1: starting position: side lying, knees flexed to 90 degrees open the top knee towards the ceiling maintain contact with the medial sides of the feet with hips stacked. Shoulder bridge level 1: starting position: crook lying, inhale and during exhalation role the spine up vertebra by vertebra, leading from coccyx and as far as shoulder blades. Scissors level 1: starting position: supine, one knee is lifted over the hip (90 degrees angle at the knee and hip) while keeping the pelvis in neutral. Arm opening level 1: The uppermost arm is lifted away from the body to open the upper chest and rotate the thoracic and lumbar spine. Breast stroke prep level 1: starting position: prone, Shoulder blade glide gently downwards away from the ears while lifting the arms 4-5 cm off the mat. Breast stroke prep level 2: As for level 1 with the upper body lengthened off the mat to hover the breastbone 3 cm from the floor while maintaining a neutral lumbo-pelvic position. Keep the back of the neck long. This exercise retrains co-activation of deep and serratus anterior, neck flexors and extensors with upper, lower trapezius [Mallin]. 20
Control Group traditional treatment 3times/week 12 weeks Subjects will receive exercises which included neck active ROM exercises, chin in, scapular retraction, neck isometric exercises, stretching of the neck extensors and pectorals, moist heat (hot pack) for 10 minutes.Precaution and ergonomic advice These exercises will give as home program to the subjects. ( Nandita et al., 2018) Dosage: exercises 5 sets × 10 repetitions with 2 min rest between each set for 12 weeks. ( Nandita et al., 2018) 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- The patients aged will be ranged from 18-38 2- from both genders 3-severity of pain is more than 3 in visual analogue scale 4- The patients suffered from chronic mechanical neck pain without neurological signs for more than 12 weeks Neck pain associated with whiplash injuries. 2- History of cervical spine surgery. 3- Cervical radiculopathy or myelopathy. 4- Having undergone physical therapy within the past 3 months before the study 5- Non-rheumatologic diseases as multiple sclerosis , thyroid dysfunction and chronic infection. 6- Medical red flag history (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 38 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
No 02/08/2020 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
7th elzayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome muscle activity as root mean square will be measured by EMG for1- upper trapezius 2- anterior scalene 3- splenius capetis 4-sternocleidomastoid before and after completion of study
Secondary Outcome pain and function will be measured by Arabic neck disability index before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy out patient 7th el zayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
shaimaa shaaban 7th el zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7th elzayat street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
maher kabalawy 7th el zayat street giza 12511 Egypt
mahmoud sayed mahmoud 7th el zayat street giza 12511 Egypt
al shaymaa shaaban 7th el zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud sayed mahmoudharidy88@gmail.com 01007383810 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt physical therapy at el wafaa hospital
Role Name Email Phone Street address
Scientific Enquiries maher el kabalawy elkabalawy@yahoo.com 01001419544 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries al shaymaa shaaban shimaashaaban30@yahoo.com 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of1- pain, 2-function 3- muscle activity Study Protocol one year the criteria will be accessed by publication at international journal
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