Clinical trial NCT06597643: The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
Official title: The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis (tennis Elbow)
Keywords: Lateral Epicondylitis
Eccentric Training
Deep Friction Massage (DFM
Wrist Extensor Strength
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 18.5 and 29.9, 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 \&#34;no pain\&#34; to \&#34;worst pain.\&#34; 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.

Eligibility criteria: Inclusion Criteria:

* Both gender male and female
* Age from 16 to 30
* Unilateral elbow pain
* Body mass index ranges from 18.5 to 29.9
* Non athletic patient
* Chronic LE don't receive PT for 6 months

Exclusion Criteria:

* Any injury or disease around the shoulder, elbow and wrist on the affected side
* Any b local intervention such as injection of steroids 6 month prior to the intervention
* Cervical radiculopathy
* History of fracture of radius, ulna and humerus with resultant deformity of the affected extremity
* Neurological impairments

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: -Disability of the Arm, Shoulder and Hand questionnaire Arabic version
timeFrame: 4 weeks
measure: Hand-held Dynamometer
timeFrame: 4 weeks
measure: -Jamar grip dynamometer
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Enas Fawzy yousef, Phd
role: STUDY_CHAIR
affiliation: Pharos university in alexanderia
name: Mai Mohamed Abdelkader, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: sherif Hamdy Zawam, PhD
role: STUDY_DIRECTOR
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