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.: PACTR202206524864970 Date of Approval: 10/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Augmented effect of dry needling and instrument assisted soft tissue mobilization on pain and function in patellofemoral pain syndrome: A randomized Controlled trial
Official scientific title Augmented effect of dry needling and instrument assisted soft tissue mobilization on pain and function in patellofemoral pain syndrome: A randomized Controlled trial
Brief summary describing the background and objectives of the trial PURPOSE: The aim of this study is to investigate the augmented effect of instrument assisted soft tissue mobilization (IASTM) and dynamic deep dry needling (DDDN) on pain and function in lateral elbow tendinopathy BACKGROUND: Myofascial trigger points (MTrPs) may account for the development of muscle cramps, accelerated fatigability and the development of chronic myofascial pain syndrome (MPS) and tendinopathy. Patellofemoral pain syndrome (PFPS) is claimed to be one of the most significant clinical knee problems in young active individuals and may affect up to 40% of the population. The condition is usually defined as a syndrome of pain in the area of anterior or medial aspect of the knee, aggravated by patellofemoral compressive forces and active overloading activities, such as prolonged sitting, squatting and stair climbing, which can limit several aspects of daily life. There is also evidence that MTrPs in the quadriceps femoris muscle group, particularly in the vastus medialis obliquus (VMO) can provoke a combination of PFPS signs and symptoms. Instrument assisted soft tissue mobilization (PPR) and dynamic deep dry needling (DDDN) are two recognized techniques used in the management of MPS and soft tissue lesions.
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 06/08/2022
Actual trial start date 17/10/2023
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Instrument assisted soft tissue mobilization with passive stretch 5 Minutes 3 times per week for 4 consecutive weeks For IASTM, treatment will commence with the participant positioned in a relaxed sitting position and a lubricant will be applied to the skin around the whole length of the thigh across the quadriceps femoris prior to treatment. Then using a M2T blade the exact areas of restriction in the quadriceps femoris will be located at an angle of 45 then slow strokes will be applied along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 5 min. Passive stretch will be applied for the quadriceps femoris held for 30sec and repeated 4-5 times 25
Experimental Group Dynamic dry needling 5 minutes 3 times per week for 4 consecutive weeks Trigger point dynamic deep dry needling; Treatment will commence with the participant positioned in a relaxed supine position and the thigh rested on the treatment table. The skin will be disinfected and prepared with 70% isopropyl alcohol before needling. A pincer grip technique will used to gently lift the skin. DDDN will be performed with a sterile, disposable, solid filament, stainless-steel needle (0.25 diameter×30mm length; Suzhou Tianxie Acupuncture instruments, Suzhou, China) over the marked MTrPs found in the quadriceps femoris. The needle will be inserted in a 45° oblique angle, in an anterior–posterior direction, perpendicular to muscle fibers, to engage the whole MTrP, using a guide tube that will be then removed. The depth of needle penetration will be ∼10–15 mm, engaging into the MTrP so as to obtain a local twitch response. Once the first local witch response will be obtained, the needle will be moved in a slow, steady, lancing, and pistoning motion, up and down in the muscle (5–7mm vertical and oblique motions with no rotations) at ∼1Hz for 30–60 s. Subsequently, the needle will be withdrawn, and the tissue will be compressed for 10–30 s using a cotton swab to ensure adequate hemostasis. Passive stretch will be applied for the quadriceps femoris held for 30sec and repeated 4-5 times 25
Experimental Group dynamic deep dry needling and Instrument assisted soft tissue mobilization 5 minutes each; with a total of 10 minutes 3 times per week for 4 consecutive weeks Trigger point dynamic deep dry needling; Treatment will commence with the participant positioned in a relaxed supine position and the thigh rested on the treatment table. The skin will be disinfected and prepared with 70% isopropyl alcohol before needling. A pincer grip technique will used to gently lift the skin. DDDN will be performed with a sterile, disposable, solid filament, stainless-steel needle (0.25 diameter×30mm length; Suzhou Tianxie Acupuncture instruments, Suzhou, China) over the marked MTrPs found in the quadriceps femoris. The needle will be inserted in a 45° oblique angle, in an anterior–posterior direction, perpendicular to muscle fibers, to engage the whole MTrP, using a guide tube that will be then removed. The depth of needle penetration will be ∼10–15 mm, engaging into the MTrP so as to obtain a local twitch response. Once the first local witch response will be obtained, the needle will be moved in a slow, steady, lancing, and pistoning motion, up and down in the muscle (5–7mm vertical and oblique motions with no rotations) at ∼1Hz for 30–60 s. Subsequently, the needle will be withdrawn, and the tissue will be compressed for 10–30 s using a cotton swab to ensure adequate hemostasis. For IASTM, treatment will commence with the participant positioned in a relaxed supine position and lubricant will be applied to the skin around the whole length of the thigh across the quadriceps femoris prior to treatment. Then using a M2T blade the exact areas of restriction in the quadriceps femoris will be located at an angle of 45 then slow strokes will be applied along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 5 min. Passive stretch will be applied for the quadriceps femoris held for 30sec and repeated 4-5 times. 25
Control Group Passive stretch total of 2 minutes; 30 sec hold and repeated 4-5 times 3 times per week for 4 consecutive weeks Passive stretch will be applied for the quadriceps femoris held for 30sec and repeated 4-5 times. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
One hundred participants with LET with age ranging from 15 to 25 years of age and at least one active‐MTrPs in the quadriceps femoris will be simply and randomly allocated into four groups—the DDDN; the IASTM; the DDDN and IASTM and the control group. Participants who will meet the following criteria will be selected for this study: (1) pain during eccentric step test, patellar apprehension test or VM coordination test (2) pain for more than 6 weeks during at least two of the following activities of walking, squatting, prolonged sitting, stair climbing, isometric quadriceps contraction and patellar compression (3) the presence of at least one active MTrP in the VMO of the symptomatic knee (4) Kujala questionnaire score between 40 and 70. 1- history of ligamentous insufficiency of the knee, meniscal damage, patellar subluxation or dislocation 2- spinal or lower extremity surgery 3- any systemic, orthopaedic or neurological disorder 4- recent physiotherapy programme; were excluded Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 25 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 01/06/2022 faculty of physical therapy higher education ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be pressure pain threshold (PPT) over the MTrPs. The transducer probe will be placed perpendicular over the MTrP, and pressure will be exerted by pressing the transducer firmly downward. Participants will instructed to say ‘STOP’ when the sensation first change from pressure to pain. The digital display will give the actual pressure applied at the site in kilogram-force representing the PPT value. The examiner will record three consecutive measurements of PPT levels at intervals. of 20 s, and the mean will be considered in the analysis. Prior to the beginning of the study as a pre-test measure and at the end of the 4 week treatment period a post test measure
Secondary Outcome Secondary outcome measure will include the anterior knee pain (Kujala) questionnaire. The Kujala questionnaire is a self-administered scale designed to evaluate functionality in patients with PFPS. The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating less pain and disability. Prior to the beginning of the study as a pre-test measure and at the end of the 4 week treatment period a post test measure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physio4life clinic 29 ahmad wasfy street almaza, heliopolis cairo 11341 Egypt
out patient clinic of faculty of physical therapy Cairo university El-Tahrir street in front of Ben El- Sarayat Traffic, Ad Doqi, Giza Giza 12613. Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mary Kamal Nassif Takla 29 ahmad wasfy almaza, heliopolis Cairo 11341 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mary Kamal Nassif Takla 29 ahmad wasfy almaza, heliopolis Cairo 11341 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rania Galal 29 ahmad wasfy almaza, heliopolis Cairo 11341 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Nassif marynassif@pt.cu.edu.eg 00201222817512 29 ahmad wasfy almaza, heliopolis
City Postal code Country Position/Affiliation
Cairo 11341 Egypt Assistant Professor of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mary Nassif marynassif@pt.cu.edu.eg 00201222817512 29 ahmad wasfy almaza, heliopolis
City Postal code Country Position/Affiliation
Cairo 11341 Egypt Assistant professor of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries Rania Galal raniagalal2011@yahoo.com 00201027466207 29 ahmad wasfy almaza, heliopolis
City Postal code Country Position/Affiliation
Cairo 11341 Egypt Lecturer of Physical therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in dynamic dry needling and instrument assisted soft tissue mobilization. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: marynassif@pt.cu.edu.eg Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Open to qualified researchers with academic interest in dynamic dry needling and instrument assisted soft tissue mobilization. Data or samples shared will be coded, with no PHI included. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: marynassif@pt.cu.edu.eg
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