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.: PACTR201807573146508 Date of Approval: 30/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Efficacy of Neck Stabilization and Pilates Exercises on Pain, Sleep disorder and Kinesiophobia in Patients with Non-Specific Chronic Neck Pain
Official scientific title Comparative Efficacy of Neck Stabilization and Pilates Exercises on Pain, Sleep disorder and Kinesiophobia in Patients with Non-Specific Chronic Neck Pain
Brief summary describing the background and objectives of the trial A decline in deep cervical flexor function has been reported to occur in patients with non-specific chronic neck pain (NSCNP) consequently leading to a compensatory increase in superficial muscle activity around the neck and shoulder girdle and this can lead to fatigue of the superficial muscles when sustained. Neck stabilization exercises and Pilates exercises has been reported to be effective in correcting imbalances of activity between deep stabilizing muscles and the superficial muscles of the neck in patients with NSCNP but it is not clear which of the exercise regimen is more effective in reducing the associated outcomes such as pain, functional disability, reduced cervical range of motion and kinesiophobia. Hence, the purpose of this study is to compare the efficacy of Neck stabilization exercises and Pilates exercises on pain, cervical range of motion (CROM), sleep disorder, kinesiophobia and functional disability in individuals with Non-specific chronic neck pain.
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 Treatment: Other
Anticipated trial start date 09/07/2018
Actual trial start date
Anticipated date of last follow up 29/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neck Stabilization Exercises 12 counts of 5 repetitions for 3 sets 30 minutes for each seesion (two sessions per week for 8 weeks -16 sessions) Chin Tuck-in: Participant lies supine on the plinth with the neck supported. Participant will be instructed to tuck their chin in or look down without bending their head -12 counts, 5 repetitions for 3 sets (Anuja et al, 2012). Shoulder Shrugs: In a standing position, the patient will be asked to shrug his or her shoulders, bringing them up towards the ears. This will be done for 12 counts of 5 repetitions, 3 sets (Kaka et al, 2016). Cervical Extension: In a standing position, the participant will grasp the base of the neck, with both hands, while extending the neck as far as possible. This will be done for 12 counts of 5 repetitions, 3 sets (Kaka et al, 2016). Craniocervical flexion with cervical flexion: Patient will lie supine and be instructed to tuck the chin and lift the head off so that the chin touches the chest. This will be done for 5 repetitions, 3 sets (Anuja et al, 2012). Shoulder blade stabilization: Participants will be instructed to stand with arms by the sides and the head and neck kept in neutral position, with chest lifted patients will gently but firmly move both shoulders backward while squeezing both shoulder blades backward and downwards. Patient will hold for 12 counts and perform 2 sets of 5 repetitions. Patients will progress to the next phase of these exercises at 4th week, if they can carry out the first phase exercises with good control and can withstand the number of holds and repetitions (Anuja et al, 2012). Chin Tuck-in: Patient will assume a quadruped position and will be instructed to tuck in their chin without bending the neck – 3 sets of 15 repetitions (Anuja et al, 2012). Craniocervical flexion with cervical flexion: Patients will progress by manually applying resistance and will be instructed to perform 3 sets of 12 repetitions of craniocervical and cervical flexion for 2weeks and by the 6th week, they will progress to 3 sets of 15 repetitions (Anuja et al, 2012). Shoulder blade stabilization: 20seconds hold, 10 reps for 2set 20
Experimental Group Pilates Exercises 20-50 repititions 30 minutes for each session (twice per week for 8 weeks - A total of 16 sessions) Hip Twist Level 1: Right knee moves away from and then towards midline while maintaining a neutral spine position. This challenges rotational control of the lumbar spine (APPI, 2012). One leg stretch Level 1: The left heel slides along mat extending left leg without allowing the pelvis to anteriorly tilt (APPI, 2012). Rolling like a ball: Participant is asked to lie supine while inhaling to engage the abdominals. The hands are placed on the knees and drawn towards the chest. The head is curled off the mat looking towards the abdominals. The hands will be slide to the back of the thighs as the participant tries to rock through the lumbosacral position for 20 counts (APPI, 2012). Shoulder Bridge Level 1: The Pelvis is tilted posteriorly as the lumbar and thoracic spines are mobilised into flexion (APPI, 2012). The Hundred Level 1: Participant is asked to lie supine and bend the knees while inhaling to engage the abdominals. The head, neck and upper shoulders are lifted off the plinth with eyes focusing on the abdominals. The head is kept above the level of spine – 20 counts (APPI, 2012). Windmill Arm Level 1: The uppermost arm is lifted away from the body to open the upper chest and rotate the thoracic and lumbar spine (figure 9). This is done for 50 counts (APPI, 2012). Breast stroke prep Level: Shoulder blades glide gently downwards away from the ears while lifting the arms 4-5 cm off the mat (figure 10) (APPI, 2012). Breast stroke prep Level 2: In addition to level, the upper body is 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 the deep neck flexors and extensors with upper, lower trapezius and serratus anterior (APPI, 2012). 20
Control Group Dynamic Isometric exercises 12 counts of 5 repetitions for 3 sets 2 sessions per week for eight weeks - A total of 16 sessions Cervical extension- dynamic isometric: The participant sits in an upright position and at the one end, the loop of the thera-band will be attached to the participant’s head and at the other, to a sturdy stand. The participant will bend neck backwards, then hold the position for 30 seconds and slowly return to the starting position, keeping the spine posture erect throughout the exercise. This will be done for 12 counts of 5 repetitions for 3 sets (Salo et al, 2010; Kaka et al, 2016). Cervical flexion-dynamic isometric: With patient in sitting, the participant will sit in an upright position and back a sturdy stand. One end of the thera-band loop will be securely attached to a sturdy stand and the other to the participant’s head. He or she will bend neck forward and hold the position for 30 seconds, before slowly returning to the starting point, while keeping the spine posture erect throughout the exercise. This will be done for 12 counts of 5 repititions for 3 sets (Salo et al, 2010; Kaka et al, 2016). Chest flies exercises: With the participant in a standing position, the middle of the thera-band will be fastened securely to a sturdy stand, set at shoulder level. The participant backed the stand, with one leg slightly in front of the other. He or she grasps the bands at shoulder height, with the elbows straight and pull the bands inward, with the palms facing each other, and then slowly return to the starting position. This exercise will be done 15 repetitions (Salo et al, 2010; Kaka et al, 2016). 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with recurrent history of non-specific neck pain of not less than 3 months. - Patients with history of non-specific chronic neck pain (NSNP) with or without pain radiating to one or both upper limbs. - Non-specific chronic neck pain patients with previous spinal surgeries. - Non-specific chronic neck pain patients with history of trauma to the neck. - Non-specific chronic neck pain patients with spinal deformity. - Patients with specific neck pain e.g. referred neck pain as a result of malignancy. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Female
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 19/07/2018 Human Research Ethics Committee of College of Medicine University Lagos
Ethics Committee Address
Street address City Postal code Country
Room 7, Ishaga Road Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Seep Disorder and Kinesiophobia Baseline, End of 4th week and End of 8th week
Secondary Outcome Cervical range of motion and Functional disability Baseline, end of 4th week and end of 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital 3 Ishaga Road, Idi-oro Idi Araba Nigeria
National Orthopaedic Hospital 120/124 Ikorodu road Igbobi Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nwanne Chiamaka 322 Road, B Close, Block 3, Flat 6 FESTAC Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chiamaka Nwanne chiamakanwanne@yahoo.com +2348036364221 322 Road, B close, Block 3, Flat 6
City Postal code Country Position/Affiliation
FESTAC Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Idi Araba Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Oluseun Fapojuwo ofapojuwo@unilag.edu.ng +2348060081382 Physiotherapy department, Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Idi Araba Lagos Nigeria Lecturer II
REPORTING
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Undecided
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Result URL Hyperlinks Link To Protocol
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