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.: PACTR202102626402431 Date of Approval: 15/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Integrated neuromuscular inhibition technique versus instrument assisted soft tissue mobilization on chronic mechanical neck pain
Official scientific title Effect of integrated neuromuscular inhibition technique versus instrument assisted soft tissue mobilization on chronic mechanical neck pain
Brief summary describing the background and objectives of the trial Mechanical neck pain (MNP) is considered a common musculoskeletal condition that has no identifiable (Fejer and Kyvik, 2006). It considered a chronic neck pain with duration of symptoms longer than three months (O'Riordan et al., 2014). The prevalence of MNP is 70% of individuals complaining of neck pain a minimum of once in their lives. Neck pain incorporates a great effect on economic productivity in modern society. So it becomes a major health problem. The integrated neuromuscular inhibition technique (INIT) is widely used in clinical practice. INIT has significant evidence in reducing pain, improving range of motion, and decreasing disability in individuals with MNP (Jyothirmai et al., 2015). Instrument Assisted Soft Tissue Mobilization (IASTM) springs from the Cyriax1 cross friction massage. IASTM could be a process during which the therapist uses a set of hand held instruments to break down the scar tissue and fascial restrictions in soft tissues to decrease pain and improve range of motion and function (Baker et al., 2013). In the literature, there is a debate about which treatment was most effective than other in reducing pain, increasing range of motion (ROM) of the neck, and improving function in the patient with chronic mechanical neck pain. The purpose of the study is to compare the effect of INIT with IASTM on pain intensity level, cervical range of motion, and neck functional level in patients with chronic MNP.
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 08/09/2020
Actual trial start date 08/09/2020
Anticipated date of last follow up 08/04/2021
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy program three sessions per week 4 weeks 1. Isometric training exercises for neck flexors, extensors, lateral flexors, and rotators. The exercises will be performed in the sitting position with the back supported in sets of 15 repetitions for each exercise. 2. Passive stretching exercises for neck extensor muscles, neck side bending muscles, and scalene muscle. 3. Chin in exercise. 4. Hot packs from sitting position for 15 minutes on the cervical region with head resting on table with a pillow. 20 Active-Treatment of Control Group
Experimental Group Integrated neuromuscular inhibition technique three sessions per week 4 weeks The first technique: Ischemic Compression The second technique: Positional Release Technique The third technique: Muscle Energy Technique 20
Experimental Group Instrument assissted sot tissue mobilization three sessions per week 4 weeks The tool will be cleaned with an alcohol pad. The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment to prevent skin irritation. The tool will be used to find areas of restriction in the upper trapezius muscle. Each participant will seat in a chair with his/her forearms resting on a treatment table. The tool will be used with an angle of 45° to apply 3 min of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to an effleurage stroke along the muscle without causing any discomfort or pain starting from the origin till the insertion). The subjects were instructed to put an ice pack if they felt any burning sensation after the session. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The subjects will be selected according to the following criteria: 1- The subjects’ age ranged from 18-38 years (Nagrale et al., 2010). 2- All subjects diagnosed as chronic mechanical neck pain 3- Patients from both genders. 4- The severity of pain on a numerical pain rating scale should be higher than two out of ten (Hussain et al., 2016). 5- Pain and stiffness last for at least 3 months (Reid et al., 2013). 6- Patients will be selected from the Physical Therapy Department in Omrania Medicine Center, Giza, Ministry Of Health, Egypt 7- Consent to participate in the study and follow the treatment schedule. The subjects will be excluded according to the following criteria (Gulick, 2018): 1. Sensory problems in the upper or mid-back regions. 2. Heart or circulation problems. 3. Cancer, diabetes mellitus, or tuberculosis. 4. Any shoulder, neck, or upper/mid back surgeries. 5. The upper or mid-back region was inspected for wounds, lesions, or infections. 6. It was confirmed that each participant was free of current upper quarter injury and was not being treated for any injury in this area (including medication). 7. Exhibiting inadequate cooperation. 8. Infections 9. Inflammatory disorders. 10. Cervical degenerative joint disease. 11. Autoimmune conditions (rheumatoid arthritis, fibromyalgia). 12. If they had receive trigger point injections in the upper trapezius muscle within the past 6 months. 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
Yes 22/04/2020 Ethics committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7th Ahmed Elzayat St., BienEl-sarayat, Dokky,Giza Giza 12618 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical range of motion immediate before starting treatment, and immediate after finishing treatment.
Secondary Outcome Pain intensity level immediate before starting treatment, and immediate after finishing treatment.
Secondary Outcome Pressure pain threshold immediate before starting treatment, and immediate after finishing treatment.
Secondary Outcome Neck functional level immediate before starting treatment, and immediate after finishing treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7th Ahmed El-zayat street, BeinElsarayat, Dokky Giza 12618 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hajar Mohammed Edris 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky Giza 12168 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky Giza 12618 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wadida ElSayed 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky Giza 12618 Egypt
Rania Reda Mohammed 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky Giza 12618 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hajar Mohammed hagermohamed249@gmail.com +201122243826 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky
City Postal code Country Position/Affiliation
Giza 12618 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries Rania Reda raniareda22@hotmail.com +201001097571 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky
City Postal code Country Position/Affiliation
Giza 12618 Egypt Lecturer of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Wadida ElSayed dr.wadida.hassan@gmail.com +201001097571 7 Ahmed El-Zayat st., Bein El-Sarayat, Dokky
City Postal code Country Position/Affiliation
Giza 12618 Egypt Professor of Physical Therapy
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 deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol 6 months following publication Anyone who wishes to access the data
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