Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597643
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Background Lateral epicondylitis LE often benefits from eccentric training exercises but combining them with deep friction massage DFM might enhance outcomes
Objective To evaluate if adding DFM to eccentric training improves pain function wrist extensor strength and hand grip strength more than eccentric training alone
Design A triple-blinded randomized controlled trial involving 46 participants aged 16-30 with unilateral LE Participants will be randomly assigned to receive either eccentric training plus sham massage Control Group or eccentric training plus DFM Experimental Group over 4 weeks
Methods Outcomes will be measured using the Visual Analogue Scale VAS for pain the Disabilities of the Arm Shoulder and Hand DASH questionnaire for function a hand-held dynamometer for wrist extensor strength and a grip dynamometer for hand grip strength
Blinding The study is triple-blinded-assessors statisticians and participants are unaware of group allocations
Significance This study aims to determine if DFM enhances the effectiveness of eccentric training in LE rehabilitation potentially leading to improved treatment protocols
Objective To evaluate if adding DFM to eccentric training improves pain function wrist extensor strength and hand grip strength more than eccentric training alone
Design A triple-blinded randomized controlled trial involving 46 participants aged 16-30 with unilateral LE Participants will be randomly assigned to receive either eccentric training plus sham massage Control Group or eccentric training plus DFM Experimental Group over 4 weeks
Methods Outcomes will be measured using the Visual Analogue Scale VAS for pain the Disabilities of the Arm Shoulder and Hand DASH questionnaire for function a hand-held dynamometer for wrist extensor strength and a grip dynamometer for hand grip strength
Blinding The study is triple-blinded-assessors statisticians and participants are unaware of group allocations
Significance This study aims to determine if DFM enhances the effectiveness of eccentric training in LE rehabilitation potentially leading to improved treatment protocols
Detailed Description:
Background Lateral epicondylitis LE also known as tennis elbow is an overuse injury of the elbow characterized by pain and functional impairment in the lateral aspect of the elbow Traditional management strategies often include eccentric training exercises aimed at improving muscle strength and reducing pain However the addition of deep friction massage DFM to such a regimen might offer additional benefits
Objective This study aims to evaluate the impact of combining deep friction massage with eccentric training exercises on pain functional ability wrist extensor strength and hand grip strength in patients with unilateral lateral epicondylitis
Design A triple-blinded randomized controlled trial RCT will be carried out at the outpatient physical therapy clinic of Pharos University in Alexandria Egypt The trial is designed to assess whether the integration of DFM with eccentric training offers superior outcomes compared to eccentric training alone
Participants The study will involve 46 patients aged 16 to 30 years diagnosed with unilateral lateral epicondylitis Participants will be randomly assigned to one of two groups Group A Control and Group B Experimental Inclusion criteria include unilateral elbow pain a BMI between 185 and 299 and chronic LE not treated with physical therapy in the past six months Exclusion criteria include significant injuries or diseases affecting the shoulder elbow or wrist recent local steroid injections cervical radiculopathy and neurological impairments
Interventions
Control Group Group A Participants will receive eccentric training exercises and sham massage The eccentric training regimen includes three exercises eccentric wrist extension with dumbbells eccentric wrist extension with a twist-bar and eccentric supination with an elastic band Sham massage will be used to maintain blinding
Experimental Group Group B Participants will receive the same eccentric training exercises as Group A plus deep friction massage DFM DFM will be applied to the extensor carpi radialis brevis tendon at the site of the common extensor origin with firm pressure applied perpendicular to the tendon for 5 minutes before each exercise session
Outcome Measures
Pain Assessed using the Visual Analogue Scale VAS which allows patients to rate pain intensity on a 100 mm line ranging from 34no pain34 to 34worst pain34 Function Evaluated using the Disabilities of the Arm Shoulder and Hand DASH questionnaire which includes 30 items measuring both function and symptoms in upper limb activities Scores range from 0 no disability to 100 severe disability
Wrist Extensor Strength Measured with a hand-held dynamometer quantifying the maximum isometric strength of wrist extensors
Hand Grip Strength Assessed using a Jamar grip dynamometer recording the maximum grip strength in kilograms
Blinding and Randomization The study will use a triple-blinding approach Research assistants conducting assessments will be blinded to group allocations as will the statisticians analyzing the data Participants will also be unaware of their group assignment Randomization will be achieved using an online random number generator to ensure unbiased group assignment
Significance This study seeks to determine if combining deep friction massage with eccentric training provides additional benefits over eccentric training alone in terms of pain reduction functional improvement and strength enhancement in patients with lateral epicondylitis The results could inform more effective rehabilitation strategies for this common condition
Objective This study aims to evaluate the impact of combining deep friction massage with eccentric training exercises on pain functional ability wrist extensor strength and hand grip strength in patients with unilateral lateral epicondylitis
Design A triple-blinded randomized controlled trial RCT will be carried out at the outpatient physical therapy clinic of Pharos University in Alexandria Egypt The trial is designed to assess whether the integration of DFM with eccentric training offers superior outcomes compared to eccentric training alone
Participants The study will involve 46 patients aged 16 to 30 years diagnosed with unilateral lateral epicondylitis Participants will be randomly assigned to one of two groups Group A Control and Group B Experimental Inclusion criteria include unilateral elbow pain a BMI between 185 and 299 and chronic LE not treated with physical therapy in the past six months Exclusion criteria include significant injuries or diseases affecting the shoulder elbow or wrist recent local steroid injections cervical radiculopathy and neurological impairments
Interventions
Control Group Group A Participants will receive eccentric training exercises and sham massage The eccentric training regimen includes three exercises eccentric wrist extension with dumbbells eccentric wrist extension with a twist-bar and eccentric supination with an elastic band Sham massage will be used to maintain blinding
Experimental Group Group B Participants will receive the same eccentric training exercises as Group A plus deep friction massage DFM DFM will be applied to the extensor carpi radialis brevis tendon at the site of the common extensor origin with firm pressure applied perpendicular to the tendon for 5 minutes before each exercise session
Outcome Measures
Pain Assessed using the Visual Analogue Scale VAS which allows patients to rate pain intensity on a 100 mm line ranging from 34no pain34 to 34worst pain34 Function Evaluated using the Disabilities of the Arm Shoulder and Hand DASH questionnaire which includes 30 items measuring both function and symptoms in upper limb activities Scores range from 0 no disability to 100 severe disability
Wrist Extensor Strength Measured with a hand-held dynamometer quantifying the maximum isometric strength of wrist extensors
Hand Grip Strength Assessed using a Jamar grip dynamometer recording the maximum grip strength in kilograms
Blinding and Randomization The study will use a triple-blinding approach Research assistants conducting assessments will be blinded to group allocations as will the statisticians analyzing the data Participants will also be unaware of their group assignment Randomization will be achieved using an online random number generator to ensure unbiased group assignment
Significance This study seeks to determine if combining deep friction massage with eccentric training provides additional benefits over eccentric training alone in terms of pain reduction functional improvement and strength enhancement in patients with lateral epicondylitis The results could inform more effective rehabilitation strategies for this common condition
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