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.: PACTR201911702692851 Date of Approval: 19/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of high power pain threshold ultrasound on knee Osteoarthritis
Official scientific title Effect of high power pain threshold ultrasound on knee Osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is a common degeneration disease characterized with joint pain, tenderness and decrease function and range of motion. The aim of this study is to evaluate and compare the therapeutic effects of the high power pain threshold ultrasound technique to conventional ultrasound techniques on knee osteoarthritis.if the high power pain threshold ultrasound technique offer more effective in treatment .it will help in decreasing cost of treatment by decreasing the number of sessions to gain the same effect of traditional US but in shorter time.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2019
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 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
Experimental Group Group B high power pain threshold ultrasound continuous mode, 1 MHZ, intensity 1.5 W/ cm² 2 session per week for four weeks intervention group B received HPPTUS using the same device at the same mode and frequency, the probe was held fixed knee and the US dose was increased until the patient felt unbearable pain. The probe was held steady for 3 s at the dose at which unbearable 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 on knee joint for 15 s then the dose was increased again in the same way. The maximum dose which could be applied to this group of patients for 3 s was seen to vary between 1.5 and 2.5 W/ cm² (Unalan et al., 2011; Majlesi andUnalan, 2004) 20
Control Group group A continuous mode, 1 MHZ, intensity 1.5 W/ cm² 2 session per week for four weeks intervention group A received a standard dose of US therapy (conventional US), continuous mode, 1 MHZ, intensity 1.5 W/ cm² moving the head of US device in a circular motion over the trigger point for 5 min . 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 40- 50 years, knee OA fulfilling the ACR classification criteria, Kellgren& Lawrence class rating of II, and knee pain, and limitation on most days within the past 6 months rheumatoid arthritis, gouty arthritis, infectious arthritis, a history of knee joint replacement on the study knee, currepast (within 6 months) oral or intra-articular corticosteroid use, physiotherapy, acupuncture treatment, the use of exercises specifically for the knee within the past 6 months, a medical condition that precludes safe exercise (such as uncontrolled hypertension, a heart condition, hematological diseases coagulopathy, gastrointestinal ulcers, or a hemorrhage), a history of taking NSAIDs or symptomatic slow-acting drugs for OA (diacerein, hyaluronic acid) within the previous 30 days, the inability to complete the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 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
No 01/12/2019 faculty of physical therapy cairo university egypt
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the effectiveness of using high power pain threshold ultrasound in treating patient with knee osteoarthritis in reduce pain ,tendreness,and increase ROM in less time and less sessions. after 4 weeks at the end of treatment
Secondary Outcome to evaluate effectiveness of convention ultrasound in patient with knee osteoarthritis after 4 weeks at the end of tratments
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university egypt El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
yomna farag ahmed 6-10B-St Maddi , cairo, Egypt cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor yomna farag ahmed 6-10B-St Maadi , Cairo, Egypt cairo 11865 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
yomna farag ahmed 6-10B-St Maddi , cairo, Egypt cairo 11865 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yomna farag monekareem@gmail.com 01115162092 6-10B-St Maadi , Cairo, Egypt
City Postal code Country Position/Affiliation
cairo 11865 Egypt principle investigator
Role Name Email Phone Street address
Public Enquiries shaimaa taha dr.shymaelshazly@yahoo.com 01229823327 45 fesal street
City Postal code Country Position/Affiliation
giza 11865 Egypt public enquirers
Role Name Email Phone Street address
Scientific Enquiries yomna farag monekareem@gmail.com 0115162092 6-10B-St Maddi , cairo, Egypt
City Postal code Country Position/Affiliation
cairo 11865 Egypt scientific inquire
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data under lies the results reported in this article (text,tables ,figures ,appendices) beginning from 6-12 months after publication controlled access through authors mails
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