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.: PACTR20180840946173 Date of Approval: 21/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ICE MASSAGE ON MECHANICAL NECK PAIN
Official scientific title ICE MASSAGE WITH INTEGRATED NEUROMUSCULER INHIBITION TECHNIQUE ON MECHANICAL NECK PAIN
Brief summary describing the background and objectives of the trial Neck pain is ranked 4th major ep­idemic responsible for an individual’s year lived with disability costs millions of money in treatment.The effectiveness of integrated neuromuscular inhibition technique INIT was reported in many articles which showed rapid results in reducing pain and stickiness.It has been found that cryotherapy causes a significant increase in pain threshold, decrease in nerve conduction velocity and vasodilatation after hunting response, increases nutrition and also speeds blood circulation to deep tissues and muscles. In the past clinicians have found that for the relief of MTrP (myofacial trigger point) distress, many patients preferred application of heat to cold however some patients preferred application of cold to MTrPs, so there is debate in using cold with MTrP. So this study is intended to investigate and compare between the effect of ice massage with INIT versus INIT on pain, cervical lateral flexion and neck functional abilities during treatment of upper trapezius trigger points in subjects with mechanical neck pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT MTrp IC MET
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 06/05/2018
Actual trial start date 06/06/2018
Anticipated date of last follow up 06/08/2018
Actual Last follow-up date 15/07/2018
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL http://www.lib.pt.cu.edu.eg
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Integrated neuromusculer inhibition technique 6 sessions (3 sessions per week) 2 weeks  Integrated neuromuscular inhibition technique: To reduce tension at the upper fiber of trapezius the subject was positioned at supine. The site of trigger point identified by asking the subjects about the area of pain then by pincer palpation the investigator determines the trigger points. Once the trigger points identified intermittent ischemic compression started by the pincer grip of trigger point by using thumb and index. The pressure applied in an interrupted pathway five seconds on and five seconds off then continuously for 90 seconds depending on the tolerability of subjects then repeated three times per session. Strain counter strain started by applying pressure at trigger point and asked the subject about the level of pain. The subject head was passively side bending towards the affected side by one hand of the investigator. The other hand held the subject’s forearm and moved the affected side shoulder passively to 900 of abduction while monitoring the trigger point pain then asked the patient about the degree of pain. If pain decreased by 70% from the beginning the position maintained for 90 seconds and repeated three times/session. After finishing strain counter strain muscle energy technique started. The affected side shoulder was stabilized by one hand of the investigator and the other hand on the mastoid area at the side of the head. The subject was requested to move the stabilized shoulder and ear towards each other. The contraction was maintained for seven seconds with 20% of maximum voluntary contraction. Then the muscle stretched for 30 seconds. This technique repeated three times per session. 20 Active-Treatment of Control Group
Experimental Group Ice massage with integrteg neuromusculer inhibition technique 6 sessions (3 sessions per week) 2 weeks  Cryotherapy in the form of ice massage for 10 min followed by period of 10 min relaxation until hunting reflex and complete vasodilatation occur. Integrated neuromuscular inhibition technique: To reduce tension at the upper fiber of trapezius the subject was positioned at supine. The site of trigger point identified by asking the subjects about the area of pain then by pincer palpation the investigator determines the trigger points. Once the trigger points identified intermittent ischemic compression started by the pincer grip of trigger point by using thumb and index. The pressure applied in an interrupted pathway five seconds on and five seconds off then continuously for 90 seconds depending on the tolerability of subjects then repeated three times per session. Strain counter strain started by applying pressure at trigger point and asked the subject about the level of pain. The subject head was passively side bending towards the affected side by one hand of the investigator. The other hand held the subject’s forearm and moved the affected side shoulder passively to 90 degree of abduction while monitoring the trigger point pain then asked the patient about the degree of pain. If pain decreased by 70% from the beginning the position maintained for 90 seconds and repeated three times/session. After finishing strain counter strain muscle energy technique started. The affected side shoulder was stabilized by one hand of the investigator and the other hand on the mastoid area at the side of the head. The subject was requested to move the stabilized shoulder and ear towards each other. The contraction was maintained for seven seconds with 20% of maximum voluntary contraction. Then the muscle stretched for 30 seconds. This technique repeated three times per session. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with age 18-35 years. Both male and female with active myofascial trigger points of upper trapezius. Unilateral trigger point. Subjects had pain at rest, jump sign at pressure, limited ROM and referred pain History of cervical spine surgery, whiplash injury and any degenerative disease. Neck and back deformities like Torticollis, scoliosis etc. Trigger point injections with in past 6 months Skin diseases and lesions in the area of trapezius Participants taking analgesic or anti-coagulant medication Adult: 19 Year-44 Year 18 Year(s) 35 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 06/05/2018 Cairo University Fculty of Physicaltherapy
Ethics Committee Address
Street address City Postal code Country
Ben El-Sarayat Traffic Street Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intenisty and pain pressure threshold pretreatment and post treatment
Secondary Outcome cervical sidebending range of motion and neck functional abilities pretreatment and posttreatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy out clinic in Elshiekh Zayed Family Medicine Center Ministry of Health and Population. 1 st neighboring, 11district Elshiekh Zayed 12593 Egypt
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 Faculty of physical therapy cairo univesity Ben-elsarayat Giza 12613 Egypt University
Secondary Sponsor Sadek Ibrahim Elpostan Elshiekh zaied 12953 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amaal Hasan aebrahim123@hotmail.com 00201200861702 Makram Ebeed
City Postal code Country Position/Affiliation
New cairo 12613 Egypt prof.Dr.Basic sience department facultyof physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries omnia mohamed omnia.mohamed.elgendy@gmail.com 00201090271472 Elpostan
City Postal code Country Position/Affiliation
Elshiekh zaied 12593 Egypt physicaltherapist
Role Name Email Phone Street address
Scientific Enquiries Dalia Mosaad Drdaliamosaad@Gmail.com 00201001469096 New Cairo
City Postal code Country Position/Affiliation
New Cairo 12613 Egypt Assistant prof.faculty of physicaltherapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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