- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707117
Effects of Tendon Neuroplastic Training (TNT) in Lateral Epicondylitis.
Effects of Tendon Neuroplastic Training (TNT) on Pain and Strength in Lateral Epicondylitis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Capital
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Islamabad, Capital, Pakistan, 46000
- National Institute of Rehabilitation Medicine (NIRM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A: Tendon neuroplastic training (TNT)
the strength training of the wrist extensors are being done with the help of an externally pace device
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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.
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Active Comparator: Group B: Conventional treatment
static stretching and myofascial release on wrist extensors
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric pain Rating scale (NPRS)
Time Frame: 4th week
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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
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4th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient rated tennis elbow evaluation (functional status).
Time Frame: 4th week
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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
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4th week
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Dynamometer
Time Frame: 4th week
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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
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4th week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah IU Muhammad Hamza khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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