Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538194
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis A Prospective Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A total of 84 patients with lateral epicondylitis were included in the study The patients were randomly assigned to 3 treatment groups mesotherapy n 28 prolotherapy n 28 and control n 28 Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale VAS during resting activity and at night and for functional status with a short version of the upper limb-specific disabilities of the arms shoulder and hand Quick-Dash and Oxford Elbow Score
Detailed Description:
This randomised-controlled single-blind prospective study was carried out at a Physical Medicine and Rehabilitation out-patient clinic After approval by the Ethics Committee all participants signed a written informed consent form The research was conducted in accordance with the Helsinki Declaration
Participants
The study will include individuals with lateral epicondylitis who are between the ages of 20 and 60 and have had elbow pain for at least three months Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis Patients with the following exclusion criteria were not accepted into the study
Recent upper-extremity surgery
Recent upper extremity trauma fracture or dislocation
Upper-extremity peripheral neuropathy
Infectious processes of joint or soft tissues of the upper extremity
Decompensated heart or respiratory failure
Rheumatologic Diseases
Psychiatric Disorders
History of allergy to ingredients of injection solution
Demographic informations were recorded Severity of elbow pain in resting activity and if present night pain were recorded according to Visual analogue Scale VAS Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms Shoulder and Hand Quick-Dash and Oxford Elbow Score
Following clinical assessment patients were divided into three treatment groups randomly Mesotherapy Prolotherapy and Control groups Exercise and resting wrist splints were recommended for all groups
The first group received mesotherapy For this group a solution containing 1 cc each of lidocaine pentoxifylline vitamin B complex diluted 110 with saline thiocolchicoside and meloxicam diluted 15 with saline will be made A 30 gauge 4 mm mesotherapy injector will be used for the application The lateral epicondyle will be the site of an intradermal injection Of that amount 25 cc will be applied point-by-point at intervals of 1-2 cm and the remaining 25 cc will be applied using the napage method 01 cc of solution were given with each injection
Group 2 received dextrose prolotherapy A 22 gauge syringe was used to apply a total of 5 cc of 15 dextrose solution a combination of 375 ml 20 dextrose and 125 mg 2 lidocaine to at least 5 most sensitive points of the lateral epicondyle It was injected 3 times with 3 weeks intervals
Only exercise and resting wrist splints will be administered to the third group which is the control group
All measures were conducted at baseline after treatment at 3th and 8th weeks follow-ups
Participants
The study will include individuals with lateral epicondylitis who are between the ages of 20 and 60 and have had elbow pain for at least three months Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis Patients with the following exclusion criteria were not accepted into the study
Recent upper-extremity surgery
Recent upper extremity trauma fracture or dislocation
Upper-extremity peripheral neuropathy
Infectious processes of joint or soft tissues of the upper extremity
Decompensated heart or respiratory failure
Rheumatologic Diseases
Psychiatric Disorders
History of allergy to ingredients of injection solution
Demographic informations were recorded Severity of elbow pain in resting activity and if present night pain were recorded according to Visual analogue Scale VAS Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms Shoulder and Hand Quick-Dash and Oxford Elbow Score
Following clinical assessment patients were divided into three treatment groups randomly Mesotherapy Prolotherapy and Control groups Exercise and resting wrist splints were recommended for all groups
The first group received mesotherapy For this group a solution containing 1 cc each of lidocaine pentoxifylline vitamin B complex diluted 110 with saline thiocolchicoside and meloxicam diluted 15 with saline will be made A 30 gauge 4 mm mesotherapy injector will be used for the application The lateral epicondyle will be the site of an intradermal injection Of that amount 25 cc will be applied point-by-point at intervals of 1-2 cm and the remaining 25 cc will be applied using the napage method 01 cc of solution were given with each injection
Group 2 received dextrose prolotherapy A 22 gauge syringe was used to apply a total of 5 cc of 15 dextrose solution a combination of 375 ml 20 dextrose and 125 mg 2 lidocaine to at least 5 most sensitive points of the lateral epicondyle It was injected 3 times with 3 weeks intervals
Only exercise and resting wrist splints will be administered to the third group which is the control group
All measures were conducted at baseline after treatment at 3th and 8th weeks follow-ups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None