Effects of Tendon Neuroplastic Training (TNT) in Lateral Epicondylitis.

Lateral Epicondylitis Clinical Trial

Official title:

Effects of Tendon Neuroplastic Training (TNT) on Pain and Strength in Lateral Epicondylitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707117
• Other study ID #: Riphah IU Muhammad Hamza khan
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 25, 2023

Study information

• Verified date: May 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research is to determine effects tendon neuroplastic training on strength, pain, and function in lateral epicondylitis. Randomized controlled trials will be conduct in National Institute of Rehabilitation Medicine Islamabad and Lady Reading Hospital Peshawar. The sample size is 34. The subjects will be divided in two groups, 17 subjects in tendon neuroplastic training group and 17 subjects will be assigned to conventional exercises group. Study duration is of one year. Sampling technique applied will be non-probability convenient sampling technique. Only 20-45 years old patients diagnosed with lateral epicondylitis will be included. Tools used in the study are Numeric pain scale, Dynamometer for grip strength and Patient rated tennis elbow evaluation for functional status.

Description:

Lateral epicondylitis or tennis elbow is the common musculoskeletal degenerative disorder of the extensor origin at the lateral humeral epicondyle. It is the most common overuse syndrome seen in the primary care with the annual incidence of 1% to 3% in general population. This condition is most prevalent in age group of 45-54 years. The condition effect men and women equally. It mostly effects individuals with the history of repetitive wrist extension activities. Lateral epicondylitis is the chronic symptomatic degeneration (tendinosis) of the tendon of extensor muscles of forearm. According to cyriax most common effected muscle in lateral epicondylitis is extensor carpi radialis brevis (ECRB). Patients with lateral epicondylitis present to clinic with chief complaints of decrease grip strength and increase pain which may have a significant effect on their daily life activities. Conventional treatment primarily focuses on pain management by anti-inflammatory medicine, Ultrasound, phonophoresis, ionophoresis and corticosteroid injection. In literature other physiotherapy approaches documented which includes manual therapy, stretching and strengthening exercises, electrotherapy, taping, shock-wave therapy, and acupuncture. There is greater evidence in favor of strengthening exercises in patients who have symptoms for more than 6 months. Other approaches also focus on eccentric exercises combined with static stretching exercises in treatment of tendinopathies. Isometric exercises are used to manage and reduce tendon pain. But all these interventions merely focus on the peripheral tissue and not address neuromuscular and complex corticospinal adaptation associated with the persistent pain and therefore lead to chronicity and less desirable outcomes. Tendon neuroplastic training (TNT) is proposed to address the central nervous system component and motor deficit of tendinopathies. It combines isometric or isotonic strengthening training with externally paced audio or visual cue provided by metronome rather than self-paced exercise and strongly focus on neuromuscular control with the aim to induce neuroplasticity. Corticospinal excitability and short interval cortical inhibition are factors through which we can measure motor control and is found altered in tendinopathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 25, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Both male and female
• Age between 20-45 years
• Pain and Tenderness over the lateral epicondyle
• At least 2 of cozen's test, Maudsley's test and Mill's test will cause pain at lateral epicondylitis.

Exclusion Criteria:

• Open wounds
• Fracture of elbow Humerus, radius, ulna
• Surgical procedure done around the elbow joint.
• Elbow instability.
• Extensor tendon rupture.
• Symptoms of cervical radiculopathy.
• Radial nerve entrapment.
• Major upper limb surgery.
• Tumor or wound
• Compartment syndrome of anconeus muscle.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Other:
• Tendon neuroplastic training (TNT)
Subjects will attend physical therapy for three non-consecutive days per week for a total 4 consecutive weeks. Exercise would involve isolated flexion, extension with a dumbbell. This exercise would be paced with external audio/visual cue on smart phone using proMetronome app. Patients will listen to the sound and track the movement of metronome with the eyes. Pace of metronome will be set at 20 beats per minute such that each beat will be 3 sec apart. This will allow a 3sec concentric and 3 sec eccentric phases.4 sets of 8 repetitions would be completed with a 2-minute rest between each set. Exercise will begin with 3 pounds weight, but it would be made sure that this wouldn't cause pain during exercise (more than 5/10), gradual progression in weight to 5 pounds after 2nd weeks.
• group B Conventional treatment
Subjects assigned to this group will undergo static stretching of Extensor carpi radialis brevis and myofascial release for 4 weeks, 3 sessions a week. Myofascial release technique will be applied for 5 minutes and 2 reptations per session

Locations

Country	Name	City	State
Pakistan	National Institute of Rehabilitation Medicine (NIRM)	Islamabad	Capital

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric pain Rating scale (NPRS)	The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line	4th week
Secondary	Patient rated tennis elbow evaluation (functional status).	The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a specific questionnaire designed for lateral epicondylitis to assess pain and function/ disability. The PRTEE is composed of pain and function subscales, determining pain at rest and during certain activities and assessing difficulty when performing specific and usual activities over the past week on a scale of 10 options, respectively. Scores can be calculated separately for subscales and as a total PRTEE score, with 0 indicating no pain and disability, 100 indicating the worst pain and functional disability score	4th week
Secondary	Dynamometer	The protocol consists of three maximal isometric contractions without pain for 5 s with a rest period of at least 60 s. The patient performs three trials of grip strength using their involved hand while maintaining 90° elbow flexion and neutral forearm position. The patient is asked to squeeze the dynamometer as hard as possible without the sensation of pain. According to a study the mean strength of three measurements was recorded in kilograms	4th week