Lateral EpicondylitisNCT05707117
Effects of Tendon Neuroplastic Training (TNT) in Lateral Epicondylitis.
A study testing Tendon neuroplastic training (TNT) and group B Conventional treatment in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Tendon neuroplastic training (TNT) and group B Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 25 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Open wounds
- Fracture of elbow Humerus, radius, ulna
- Surgical procedure done around the elbow joint.
- Elbow instability.
- Extensor tendon rupture.
- Symptoms of cervical radiculopathy.
Show all 10Show fewer
- Radial nerve entrapment.
- Major upper limb surgery.
- Tumor or wound
- Compartment syndrome of anconeus muscle.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Rehabilitation Medicine (NIRM)
Islamabad, Capital, 46000
About this study
Official title: Effects of Tendon Neuroplastic Training (TNT) on Pain and Strength in Lateral Epicondylitis.
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Tendon neuroplastic training (TNT), group B Conventional treatment
- Keywords
- Lateral Epicondylitis, Tendon neuroplastic training, strength training
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon neuroplastic training (TNT)Other
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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: Tendon neuroplastic training (TNT) | Experimental | the strength training of the wrist extensors are being done with the help of an externally pace device Receives: Other: Tendon neuroplastic training (TNT) |
| Group B: Conventional treatment | Active comparator | static stretching and myofascial release on wrist extensors Receives: Other: group B Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4th week
Secondary outcomes (2)
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
Measured: 4th week
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
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion20 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707117
- Sponsor's protocol ID
- Riphah IU Muhammad Hamza khan
- Status last verified
- May 2023
- First submitted
- 22 Jan 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan H, Razzaq A, Afridi A, Sheraz S, Awan WA. Innovative neuroplastic healing: tendon Neuroplastic Training role in pain alleviation and boosting strength in lateral epicondylitis: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Oct 10;26(1):949. doi: 10.1186/s12891-025-08328-1.
PubMed 41073965
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tendon Neuroplastic Training (TNT) on Pain and Strength in Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT05707117
- Acronym / sponsor ID
- Riphah IU Muhammad Hamza khan
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Tendon neuroplastic training, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Tendon neuroplastic training (TNT) | Experimental | Other: Tendon neuroplastic training (TNT)the strength training of the wrist extensors are being done with the help of an externally pace device |
| Group B: Conventional treatment | Active comparator | Other: group B Conventional treatmentstatic stretching and myofascial release on wrist extensors |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Open wounds
- Fracture of elbow Humerus, radius, ulna
- Surgical procedure done around the elbow joint.
- Elbow instability.
- Extensor tendon rupture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group A: Tendon neuroplastic training (TNT) |
| group B Conventional treatmentSubjects 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 | Other | Group B: Conventional treatment |
Primary outcome
Numeric pain Rating scale (NPRS)
Time frame: 4th week
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
2 secondary outcomes
Patient rated tennis elbow evaluation (functional status).
Time frame: 4th week
Dynamometer
Time frame: 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 41073965Khan H, Razzaq A, Afridi A, Sheraz S, Awan WA. Innovative neuroplastic healing: tendon Neuroplastic Training role in pain alleviation and boosting strength in lateral epicondylitis: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Oct 10;26(1):949. doi: 10.1186/s12891-025-08328-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aisha Razzaq, MSPT-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon neuroplastic training (TNT) and group B Conventional treatment in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain Rating scale (NPRS) (time frame: 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.