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.: PACTR202203614479239 Date of Approval: 15/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Myofascial Release versus Proprioceptive Neuromuscular Facilitation in Chronic Mechanical Neck Pain: A Randomized Controlled Trial
Official scientific title Myofascial Release versus Proprioceptive Neuromuscular Facilitation on pain and range of motion in patient with Chronic Mechanical Neck Pain.
Brief summary describing the background and objectives of the trial Manual therapies are commonly used in the treatment of chronic neck pain. Myofascial Release is one of the effective manual therapy techniques in reducing pain, disability, improving the isometric extension strength of neck in patients with nonspecific chronic neck pain (Hasan N.,et al,2016). PNF involves stretching, resisted movement, traction and approximation to ameliorate muscle decline, disharmony, atrophy and joint movement limitation. It is very effective in improving flexibility, strength and range of motion (Chandani K.,et al, 2016). Several studies reported that manual therapy (MT) is more effective than a placebo treatment or no treatment at all for mechanical neck pain, but there is lack of studies that investigate which type of manual therapy approach is most effective. Although myofascial release and PNF are considered from the most beneficial techniques that decrease pain and improve range of motion and function in mechanical neck pain there is a gap in the literature concerning the comparison between myofascial versus PNF release on cervical pain in mechanical neck pain patient so this study will be conducted to investigate the effect of myofascial release versus PNF on patient with chronic mechanical neck pain regarding pain and ROM to determine the most beneficial approach and the most appropriate treatment period to decrease patient and therapist time and effort consumption.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MNP
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 31/10/2021
Actual trial start date 31/10/2021
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 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
Control Group conventional treatment 3 dayes per week 4 weeks stretching and isometric contraction for neck muscles 20 Active-Treatment of Control Group
Experimental Group conventional treatment in addition to myofascial release technique 3 dayes per week 4 weeks stretching and isometric contraction for neck muscles in addition to myofascial release technique. The treatment include four basic maneuvers. (1) First, assisted induction of the cervical fascia will perform in the supine position. The therapist suspend the patient's head with one hand under the neck and the other on the parietal region until the perception of spontaneous movement, which will follow to its maximum amplitude. (2) Second, the therapist proceed to release the myofascial restrictions of the suboccipital region from the level of the skull by flexing the metacarpophalangeal joints of the index, middle, and ring fingers to raise the atlas toward the ceiling. (3) To stretch the sternocleidomastoid muscle, the therapist made a smooth rotation of the head of the patient with one hand placed over the occipital region. The other hand will place on the belly of the sternocleidomastoid muscle with the thumb at the point of insertion in the mastoid process. One hand then apply a rotational movement and a slight extension of the head while the other performed a transverse sliding movement on the restriction zone in the muscle. (4) Finally, to lengthen the myofascial structures of the posterior cervical region, the therapist hold the patient's head at the occipital area and slowly bent the cervical spine. The other hand hold contact with the mass of the paraspinal muscles, putting the thumb on one side of the spine and just across the proximal interphalangeal joint of the index finger. While one hand hold the head, the other perform a vertical sliding downward (Manuel R., et al, 2018). 20
Experimental Group conventional treatment in addition to proprioceptive neuromuscular facilitation 3 dayes per week 4 weeks stretching and isometric exercises for neck muscle in addition to proprioceptive neuromuscular facilitation a) Head and neck flexion with rotation to right Patient’s position - Supine lying and head and neck out of plinth. Starting position- extension of the head and neck with rotation to left. Therapist’s position – Standing, one hand on the occiput and other hand on the mandible. Commands- „pull your chin up towards the sternum‟. Movement- flexion of the head and neck with rotation to the right with normal timing. Facilitation through appropriate verbal commands and manual contact (Chandani K.,et al, 2016). b) Head and neck extension with rotation to left Patient’s position- same as above The starting position- head and neck flexion with rotation to right. Therapist’s position – Standing, one hand on the occiput and other hand on the mandible. Commands-„push and look to the left‟. Movement- Extension of the head and neck with rotation to the left with normal timing. Facilitation through appropriate verbal commands and manual contact -movement will be repeated in the other direction.(Chandani K.,et al, 2016). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Both genders will participate in the study. 2. Age ranged from 20 and 50 years of both genders (Sweta V. et al, 2018). 3. Body mass index ranged from 20 to 25. 4. Subjects clinically diagnosed with mechanical neck pain referred from physician. 5. Patient complain for more than 3 months (Chandani K.,et al, 2016). 6. Patient with latent myofascial trigger points. 1. Subjects spinal infection. 2. History of neck surgery in the past 12 months. 3. Central cervical canal stenosis, torticollis, and scoliosis. 4. Neck pain with radiation to the arm and upper extremity. 5. Trauma of the neck. 6. Nerve root involvement. 7. Serious pathology like malignancy, infection and inflammatory disorders. 8. Patient with forward head posture. 9. Patient with active trigger points. 10. Patient treated by analgesics. 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 09/09/2020 faculty of physical therapy researsh ethical commitee
Ethics Committee Address
Street address City Postal code Country
7th el zayat street guiza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cervical range of motion flexion, extension, right and left side bend and right and left rotation before, after six sessions, after twelve sessions, after three months from the end of the treatment
Secondary Outcome cervical pain before , after six sessions , after twelve sessions and after three months from the end of the treatment
Primary Outcome the disability level in chronic neck pain patients before, after six sessions, after twelve sessions and after three months from the end of the treatment.
Primary Outcome pressure pain threshold of mechanical trigger points of trapezius before, after six sessions, after twelve sessions and after three months from the end of the treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th el zayat street guiza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nehal mohammed farouk 7th el zayat street guiza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university 7th el zayat street cairo 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Hassan 7th el zayat street guiza 12511 Egypt
Mohamed Abd ElHalim 7th el zayat street guiza 12511 Egypt
Rania Nagy 7th el zayat street guiza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nehal mohammed dr_nehal.mohammed@yahoo.com 021156673936 7th el zayat street
City Postal code Country Position/Affiliation
guiza 12511 Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries Amal Hassan aebrahim123@hotmail.com 01200861702 7th el zayat street
City Postal code Country Position/Affiliation
guiza 12511 Egypt Professor of Physical Therapy for Basic Sciences
Role Name Email Phone Street address
Public Enquiries Rania Nagy rania.nagy@pt.cu.edu.eg 01227244630 7th el zayat street
City Postal code Country Position/Affiliation
guiza 12511 Egypt Assistant Professor of Physical Therapy for Basic Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the individual participant data will be shared online in the form of pain ,cervical range of motion, the disability level in chronic neck pain patients, pressure pain threshold of mechanical trigger points of trapezius Study Protocol the data will be online after 1 month the criteria will be accessed by the publication of trials in the 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