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.: PACTR201907842497075 Date of Approval: 05/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Graston technique versus active soft tissue therapies on latent trigger points of upper trapezius muscle
Official scientific title Influence of instrument assisted soft tissue techniques versus active soft tissue therapies on latent trigger points of upper trapezius muscle
Brief summary describing the background and objectives of the trial Musculoskeletal disorders are tissue dysfunctions in the musculoskeletal system that arise as a result of continuous exposure to abnormal, adverse physical conditions during rest or while performing job duties, as well as steady and repeated movements leading to pain and injury in the body, especially in the neck and shoulder. Repetitive tasks with long static loads lead to the development of clinical disorders such as myofascial pain syndrome (MPS) with trigger points (TPs). There are many therapeutic approaches available for the treatment of patients with TPs, among which is manual therapy. Some studies have been conducted to identify effective treatments for soft tissue–related problems. Active release technique includes applying pressure to nodules or bands in a muscle and then the abnormal tissue being taken from contracted position to elongated position, while the therapist maintains directed manual contact along the muscle fibers is considered one of the most used manual approach. Graston Technique is a massage system revolving around several hand-held stainless-steel instruments. Graston technique promoters claim that the metal surface of the instruments does not compress the tissues, as do the fat pads of the finger, so that deeper restrictions can be accessed and treated. Given the overall lack of scientific evidence it is apparent that further high quality trials are necessary to determine the efficacy of the soft tissue massage method known as Graston Technique. We propose a study to determine the efficacy of Graston Technique compared to active release technique in the treatment of latent trigger point of upper fiber of trapezius.
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 26/04/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 15/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://doi.org/10.1002/pri.1859
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Active Soft Tissue Therapy This technique will be repeated 3-5 times per session, and each repetition will be maintained for 40-60 seconds till release is felt, with a 15-second rest interval. 6 sessions in 2 weeks Patient will sit on a chair. The therapist stand behind the participant and held 1 hand over head as the support, with the thumb of the other hand scan to detect the painful area of the latent TP of the upper trapezius muscle along the fibers; then pressure will be applied by the thumb and, the participant will asked to simultaneously and actively change the muscle from shorted position to elongated state (ipsilateral side flexion of the cervical to the opposite side). 20
Experimental Group Graston technique This technique will be applied 3-5 times per session with 20 sec rest between each time. 6 sessions in two weeks Patient will lie prone. The treatment will be applied for approximately 20-seconds in a direction parallel to the muscle fibers with the instrument at a 45° angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for an additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. 20
Control Group stretching exercise stretching is held for 30 second and repeated 5 times in each session 6 sessions in 2 weeks stretching applied for upper fiber of trapizues from sitting position 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a minimum of 1 palpable nodule in the upper trapezius muscle hypersensitive tender spot in a taut band in response to 2.5 kg/cm2 of pressure 1-A contraindication to manual therapy (inclusive of osteoporosis, thoracic fracture, spinal infection, neoplastic disorders, spondyloarthropathy, clinical examination suggestive of frank disc herniation). 2-A contraindication to Graston technique (inclusive of neoplastic disorders, kidney infection, anticoagulant medication, rheumatoid arthritis, uncontrolled hypertension, thoracic fracture, osteomyelitis or generalized infection) 3-An active history of visceral conditions referring pain to the thoracic spine (inclusive of myocardial ischemia, dissecting thoracic aortic aneurysm, peptic ulcer, acute cholecystitis, pancreatitis, renal colic, acute pyelonephritis) 4-currently receiving care for thoracic pain from any other provider 5-Myofascial pain therapy within the month before the study, 6- Active TP or jump sign. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 50 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
Yes 09/10/2018 Ethical committee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
El Tahrir street- in front of Ben El Sarayat traffic Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain pressure threshold that will be determined by pressure algometer, cervical range of motion that will be assessed by inclinometer before starting treatment and after end of 6 sessions
Secondary Outcome functional level assessed by neck disability index before treatment and after end of 6 sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Sahel teaching hospital 17 youssef karam street Cairo 11672 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha elserty 57 elmaksy street Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor noha elserty 57 elmaksy street Cairo 11672 Egypt main author
COLLABORATORS
Name Street address City Postal code Country
Dina othman nasr city 6th district Cairo 11763 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Elserty noha_elserty@hotmail.com +201006709648 57 elmaksy street
City Postal code Country Position/Affiliation
Cairo 11672 Egypt lecturer at faculty of physical therapy Egyptian Chinese University
Role Name Email Phone Street address
Public Enquiries Noha Elserty noha_elserty@hotmail.com +201006709648 57 elmaksy street
City Postal code Country Position/Affiliation
Cairo 11672 Egypt lecturer at faculty of physical therapy at Egyptian Chinese University
Role Name Email Phone Street address
Scientific Enquiries Noha Elserty noha_elserty@hotmail.com +201006709648 57 elmaksy street
City Postal code Country Position/Affiliation
Cairo 11672 Egypt lecturer of physical therapy at faculty of physical therapy at Egyptian Chinese University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD collected in this study will be shared including the underlie results published Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be shared after 6 months form publication IPD will be shared to research who work in the same field of physiotherapy and work in a point similar to the published work through corresponding with the corresponding author
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