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

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tendon neuroplastic training (TNT)
group B Conventional treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, Tendon neuroplastic training, strength training

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Rehabilitation Medicine (NIRM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Tendon neuroplastic training (TNT)

Group B: Conventional treatment

Arm Description

the strength training of the wrist extensors are being done with the help of an externally pace device

static stretching and myofascial release on wrist extensors

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
January 22, 2023
Last Updated
May 3, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05707117
Brief Title
Effects of Tendon Neuroplastic Training (TNT) in Lateral Epicondylitis.
Official Title
Effects of Tendon Neuroplastic Training (TNT) on Pain and Strength in Lateral Epicondylitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Lateral Epicondylitis, Tendon neuroplastic training, strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Tendon neuroplastic training (TNT)
Arm Type
Experimental
Arm Description
the strength training of the wrist extensors are being done with the help of an externally pace device
Arm Title
Group B: Conventional treatment
Arm Type
Active Comparator
Arm Description
static stretching and myofascial release on wrist extensors
Intervention Type
Other
Intervention Name(s)
Tendon neuroplastic training (TNT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
group B Conventional treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric pain Rating scale (NPRS)
Description
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
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Patient rated tennis elbow evaluation (functional status).
Description
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
Time Frame
4th week
Title
Dynamometer
Description
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
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine (NIRM)
City
Islamabad
State/Province
Capital
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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