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.: PACTR201712002882400 Date of Approval: 16/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Different Intensities of Ultrasound on Pain and Myoelectric Activities of Upper Trapezius Myofascial Trigger Points
Official scientific title Effect of Different Intensities of Ultrasound on Pain and Myoelectrical Activity of Upper Trapezius Myofascial Trigger Points
Brief summary describing the background and objectives of the trial Musculoskeletal pain is one among the leading reasons for visits to physicians and manual therapists, and around one-third of these patients meet the diagnostic criteria for myofascial pain syndrome (Daniels et al., 2003). Myofascial pain syndrome is a common muscular pain syndrome resulting from trigger points, which is defined as hyperirritable location with a taut band of skeletal muscle, that is painful when compressed and can give rise to characteristic referred pain, tenderness and muscle tightness (Esenyel et al., 2000).Ultrasound is an electrical modality often used for treatment of trigger points, it generates high frequency acoustic energy using the piezoelectric effect to produce thermal & non thermal effect in tissue. Ultrasound therapy has achieved recognition as an essential technique in the treatment of acute and chronic musculoskeletal disorders (Hemmings et al., 2000).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) US HPPT
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: Other
Anticipated trial start date 20/12/2017
Actual trial start date 05/02/2018
Anticipated date of last follow up 15/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 Ultrasound 6 3week The Patient will be in relaxed sitting position with a good supported back and the therapist will stand behind the patient. The area will be cleaned and the parameters according to each group will be selected. gel will be applied first over the skin to facilitate transmission of ultrasound energy, and then the treatment head of ultrasound will be moved,, continuous mode, F=1MHZ and 1.5 w-cm2 20 Placebo
Experimental Group High power pain threshold ultrasound 3 2 week Using the same US device, the probe was held ¿ xed over a trigger point and the US dose was increased until the patient felt pain. The probe was held steady for 3 s at the dose at which pain was felt then the dose was reduced by half. At this dose, the probe was moved in a circular motion over the trigger point and surrounding area then the dose was increased again in the same way. 20
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. -The patients aged will be ranged from 18 to 38 years. -The patients will be chosen from both sexes -All patients medically stable and do not suffer from any other diseases which might affect the trial results. History of whiplash injury. -History of cervical spine surgery. -Cervical radiculopathy or myelopathy. -Having undergone physical therapy within the past 3 months before the study. -Non- rheumatologic diseases as multiple scelerosis, thyroid dysfunction and chronic infection. 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 12/02/2017 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 before and after completion of study
Primary Outcome electrical activity of the upper fibres of the trapezius before and after completion of study
Secondary Outcome neck disability index 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 Cairo university Ahmed El Zayad Street Giza Egypt University
Secondary 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
Dr Eman Embaby 7 Ahmed El Zayad street Dooki Giza Egypt Giza Egypt
dr. rania nagy 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 el zayat street
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Public Enquiries rania nagy ibtsammohmed83@yahoo.com 01094502939 el zayat street
City Postal code Country Position/Affiliation
giza Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries Eman Embaby eman_ahmed@cu.edu.eg 01094502939 el zayat street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
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