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.: PACTR202402475812164 Date of Approval: 02/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized clinical trial on comparison of dry needling with or without saline solution injection for chronic lateral epicondylitis
Official scientific title The short and medium-term effectiveness of dry needling versus dry needling in addition to saline solution injection in the treatment of chronic lateral epicondylitis: randomized controlled trial
Brief summary describing the background and objectives of the trial Many randomized controlled trials (RCTs) have evaluated the therapeutic effect of injected treatments on lateral epicondylitis and most of them used saline injections as placebo. Two recent meta-analyses included these RCTs with the aim of evaluating the effect of saline injections on pain relief and improvement in function in patients with lateral epicondylitis. A statistically and clinically significant improvement in pain and function in patients with lateral epicondylitis was reported in the saline solution group. Given that the effectiveness of Dry Needling in this indication is well proven, the association of Dry Needling with saline solution gives rise to the hope of an additional clinical benefit, hence the interest of our study. Primary objective : Show the superiority of Dry Needling plus saline solution compared to Dry Needling on pain in ELC. Secondary objective: Compare the effects of the 2 approaches on: • Function through the function assessment questionnaire: PATIENT-RATED TENNIS ELBOW EVALUATION (PRTEE) • Quality of life using the EQ-5D-5L questionnaire (EuroQoL-5D). • Tolerance by evaluating the intensity and duration of pain per procedure and post procedure, respectively by visual analog pain scale from 0 to 10 and verbal pain scale from 0 to 5 for the duration of pain. • And the side effects of the different injections throughout the trial.
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: Drugs
Anticipated trial start date 04/03/2024
Actual trial start date
Anticipated date of last follow up 06/03/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Active, not 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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group dry needling 10 tendon fenestrations, using a 21 G needle 5 minutes Procedure: while respecting rigorous aseptic measures Each patient will receive an ultrasound-guided intervention only once during the procedure. The patient will be placed supine on the examination gurney, with hand supinated and elbow flexed 90°. From the center to the periphery, the skin will be disinfected with povidone-iodine. Palpation will locate the most painful site on the lateral epicondyle of the humerus. Patients randomized to the Dry Needling group will receive approximately 20 tendon fenestrations targeting the attachment of the common extensor tendons to the lateral epicondyle of the humerus, using a 21 G needle. This operation takes an estimated 5 min, from patient preparation to the end of administration. 35 Active-Treatment of Control Group
Experimental Group dry needling plus saline solution injections 10 tendon fenestrations targeting the attachment of the common extensor tendons to the lateral epicondyle of the humerus, using a 21 G needle, followed by the injection of 1.5 cc of Saline solution 0.9% This operation takes an estimated 5 min, from patient preparation to the end of administration. Procedure: while respecting rigorous aseptic measures Each patient will receive an ultrasound-guided intervention only once during the procedure. The patient will be placed supine on the examination gurney, with hand supinated and elbow flexed 90°. From the center to the periphery, the skin will be disinfected with povidone-iodine. Palpation will locate the most painful site on the lateral epicondyle of the humerus. Patients randomized to the DN plus saline solution group will receive approximately 20 tendon fenestrations targeting the attachment of the common extensor tendons to the lateral epicondyle of the humerus, using a 21 G needle, followed by the injection of 1.5 cc of Saline solution 0.9%. This operation takes an estimated 5 min, from patient preparation to the end of administration. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients with lateral epicondylitis symptoms for more than 3 months and who have failed conventional treatment which must be stopped at least 3 weeks before our intervention. Lateral epicondylitis is defined as lateral elbow pain and pain at the lateral epicondyle on direct palpation and during dorsiflexion against resistance of the wrist. Age less than 18 years history of injection for therapeutic purposes (glucocorticoids, platelet-rich plasma or Dry needling etc.) in the last 6 months Previous EL surgery History of arm or leg fracture forearm Thrombocytopenia Coagulopathy Pregnancy Breastfeeding Mental health problems Chronic inflammatory rheumatism Cervico-brachial neuralgia and other chronic generalized pain syndromes The participant's declaration that he or she will not be able to continue the research follow-up Fear of injection Presence of drug abuse Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 30/11/2023 Tangier University Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Pharmacy of Tangier, 365 Gzenaya, Km 15, Rabat road, Tangier, 30000 Tangier 90100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To demonstrate the superiority of Dry Needling plus saline solution injections versus Dry Needling alone on pain in chronic lateral epicondylitis pre-procedure, then at weeks 2, 12 and 24
Secondary Outcome Compare the effects of the 2 approaches on : - Function, using the PATIENT-RATED TENNIS ELBOW EVALUATION (PRTEE) questionnaire pre-procedure, then at weeks 2, 12 and 24
Secondary Outcome Compare the effects of the 2 approaches on : - Quality of life, using the EQ-5D-5L questionnaire (EuroQoL-5D) pre-procedure, then at weeks 2, 12 and 24
Secondary Outcome Compare the effects of the 2 approaches on : - Tolerance by assessing pain intensity and duration per procedure and post-procedure, respectively using the Visual Analogue Pain Scale from 0 to 10 and the Verbal Pain Scale from 0 to 5 for pain duration. per-procedure, then at weeks 2
Secondary Outcome The side effects of the various injections throughout the trial pre-procedure, then at weeks 2, 12 and 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CHU Mohammed VI RABAT ROAD KM 17 BP398 GZINAYA Tangier 90100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
ARUTA Rabat road Km 17 BP 398 Gzinaya Tangier Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohammed VI university hospital Road rabat Km 17 BP 398 Gzinaya Tangier 90050 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries rajaa bensaid raja.masensen@gmail.com +212642930447 75 complexe el noor, tanger
City Postal code Country Position/Affiliation
Tangier 90100 Morocco University Hospital Mohammed VI Tangier
Role Name Email Phone Street address
Principal Investigator Fatima Ezzahra Abourazzak f.abourazzak@yahoo.fr +212661601814 Al Atlassia Al ousta, bloc A Appt 116 Quartier Administratif
City Postal code Country Position/Affiliation
Tangier 90050 Morocco University Hospital Mohammed VI Tangier
Role Name Email Phone Street address
Scientific Enquiries Fatima Zahrae Taik taikfatimazhrae@gmail.com +212664466928 Tangier
City Postal code Country Position/Affiliation
Tangier 90050 Morocco University Hospital Mohammed VI Tangier
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form Beginning 3 months and ending 5 years following article publication Anyone who wishes to access the data Any types of data analysis permitted Process of requesting data/documents: contact the principal investigator Criteria for reviewing requests: reasonable request
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