The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
1 other identifier
interventional
46
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
5 months
September 10, 2024
September 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale
is used to measure the pain which is represented from (0) grade to (10) grade, with zero means no pain and ten means intolerable pain, The subjects were asked to indicate the level of pain by placing a dash at the appropriate level on the 10 cm horizontal line
4 weeks
Secondary Outcomes (3)
-Disability of the Arm, Shoulder and Hand questionnaire Arabic version
4 weeks
Hand-held Dynamometer
4 weeks
-Jamar grip dynamometer
4 weeks
Study Arms (2)
Control Group
ACTIVE COMPARATORTwenty-one patients will be assigned to group A, who will receive eccentric exercise program in addition to sham massage in the form of skin rubbing for patient blinding. for a total of 12 treatment sessions (3 sessions per week) for 4 weeks 3 sets of 15 repetitions, it takes 5 seconds to complete each repetition and between each set there is 30 seconds of rest
Experimental Group
EXPERIMENTALTwenty-one patients will be assigned to group B who will receive the same exercises as in control group (eccentric training exercises) in addition to deep friction massage (DFM) for a total of 12 treatment sessions (3 sessions per week) for 4 weeks. Before starting the exercises DFM will be performed. The patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers,
Interventions
Exercise 1: Eccentric Wrist Extension with Dumbbell Position: Seated, elbow extended, wrist maximally extended. Action: Lower: Slowly flex the wrist for 30 seconds. Return: Use the opposite hand to bring wrist back to extension. Load: Increase weight based on 10 Repetition Maximum (10RM). Exercise 2: Eccentric Wrist Extension with Twist-Bar Position: Hold Flex Bar with involved hand in extension. Action: Twist: Rotate the bar with the non-involved hand while keeping the involved wrist extended. Untwist: Allow the wrist to flex slowly. Exercise 3: Eccentric Supination with Elastic Band Position: Anchor band, elbow flexed to 90°. Action: Supinate: Rotate forearm with palm up. Flex: Slowly rotate to palm down, then return
The patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers,
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (3)
Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.
PMID: 30529085BACKGROUNDLibby AM, Pace W, Bryan C, Anderson HO, Ellis SL, Allen RR, Brandt E, Huebschmann AG, West D, Valuck RJ. Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes. Med Care. 2010 Jun;48(6 Suppl):S39-44. doi: 10.1097/MLR.0b013e3181ddc7b0.
PMID: 20473193BACKGROUNDPietrini V, Pavesi G, Andreetta F. Miller Fisher syndrome with positivity of anti-GAD antibodies. Clin Neurol Neurosurg. 2013 Nov;115(11):2399-400. doi: 10.1016/j.clineuro.2013.09.002. Epub 2013 Sep 16. No abstract available.
PMID: 24094904BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Enas Fawzy yousef, Phd
Cairo University
- STUDY DIRECTOR
Mai Mohamed Abdelkader, PhD
Pharos university in alexanderia
- STUDY DIRECTOR
sherif Hamdy Zawam, PhD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- statistician will be blind to the details of allocation and intervention in each group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 10, 2024
First Posted
September 19, 2024
Study Start
October 1, 2024
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09