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.: PACTR201803003235246 Date of Approval: 21/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Instrument Assisted Soft Tissue Mobilization versus Stripping Massage on Upper Trapezius Myofascial Trigger Points
Official scientific title Intrument assisted soft tissue mobilization versus stripping massage on pain intensity, pressure pain threshold,neck disability index, and muscle amplitude
Brief summary describing the background and objectives of the trial Myofascial pain syndrome is one of the common musculoskeletal pain disorders which affects almost 95% of people with chronic pain disorders and is a common finding in specially pain management Centre (Skootsky,1989; Simons et al, 1999 and Shah et. al, 2008).Stripping massage is an excellent method for reducing hyper-tonicity and increase pliability in muscles. It is also considered the most effective way to inactivate myofascial trigger point when using a direct manual approach (Simons, et al., 1999). Graston Technique (GT) is a soft tissue mobilization treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. It thus creates an inflammatory response to accelerate the healing process and restore flexible, normal tissue. This technique seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis (Kim et al., 2014)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GT NDI ST
Disease(s) or condition(s) being studied Musculoskeletal Diseases,myofascial pain syndrome, trigger points
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/09/2018
Actual trial start date 03/12/2018
Anticipated date of last follow up 06/04/2019
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 the patients were assigned randomly by random generator and by using permuted block of different size which was done by third person into three equal group A, B, C the allocation will be determined by a third person( the holder of the situated off site) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group graston technique 2times/week four weeks Graston Instrument Assisted Soft Tissue Mobilization (GISTM) is a specialized technique whereby the clinician uses stainless steel instruments to contact the tissue instead of the hands. An emollient is placed on the skin prior to application of the technique. Rubber gloves are used by some clinicians to improve their grip on the instruments, but their use is not mandatory (Hyde, 2003). 20
Experimental Group stripping massage 2times/week four weeks Is a deep stroking massage which is applied with minimal lubrication on the finger tips. A firm pressure is used along the length of the taut band (Travell & Simons,1983).The pressure increases progressively with each successive pass along the muscle .A milking movement from the distal to proximal end of the muscle goes over the trigger point at the rate of about 1in.(2.5cm)every 3s. 20
Control Group stretching exercise 2times/week four weeks stretch upper trapezius by side bending head to the opposite side with slight flexion 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients have active MTrPs in upper trapezius muscle unilaterally. 1-The patients have pain at rest, local twitch response, jump sign, limited ROM and referred (Fryer and Hodgson, 2005). 2-The patients aged will be ranged from 19 to 38 years. 3- The patients will be chosen from both sexes 4- All patients medically stable and do not suffer from any other diseases which might affect the trial results. 5-All patients will be referred by orthopedist. 6-Body Mass Index from 18 to 25 kg/m² 1-History of whiplash injury. 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 scelerosis,thyroid dysfunction and chronic infection. 6- Rheumatologic condition as mild systemic lupus erythematosus, polyarticular osteoarthritis,rheumatoid arthritis and advanced cervical spine degenerative diseases 19 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 02/07/2019 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El zyad street, dooki, giza, egypt GIZA 1111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity before and after completion of study
Primary Outcome pressure pain threshold before and after completion of study
Primary Outcome range of motion before and after completion of study
Primary Outcome functional disability before and after completion of study
Secondary Outcome muscle amplitude before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of faculty of physical tharapy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical tharapy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
DR.Haytham el hafez 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
salah eldein bassit 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
marry nassif 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haytham el hafez elhafez@yahoo.com 01001909630 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Public Enquiries mary nassif marytakla@hotmail.com 01001909630 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries salah eldein utcsalah@gmail.com 01001909630 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
REPORTING
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