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Lateral EpicondylitisNCT06686732

Multimodal Rehabilitation Approach in Patients of Lateral Epicondylitis

A study testing Multimodal physiotherapy and Conventional physiotherapy in people with Lateral Epicondylitis, run by Riphah International University at 3 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Literature is scarce for high quality evidence regarding multimodal rehabilitation in lateral epicondylitis. By making comparisons with the conventional treatment of patients with lateral epicondylitis, the current study aims to further establish the efficacy of the multimodal rehabilitation protocol through a RCT in… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Multimodal physiotherapy and Conventional physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesPakistan
Study dates
3 May 2024to 13 Dec 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Point tenderness at the lateral epicondyle
  • Positive Cozen test, Mill\'s test and Maudsely's test
  • Symptoms duration of minimum 2 months
  • Consenting to participate in the study

Who cannot join

  • History of fracture in elbow, wrist or hand
  • History of surgery in elbow, wrist or hand region
  • Elbow conditions other than lateral epicondylitis
  • Cognitive deficits and not giving consent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan3 sites, 3 recruiting
  • Riphah International Hospital, Sihala

    Islamabad

    Sehrish Noor, +923068989743, noor.sehrish14@gmail.com

    Recruiting
  • DSK Physio & Rehab Center

    Rawalpindi

    Muhammad Waleed Tariq, +923052087520, waleedtariq633@gmail.com

    Recruiting
  • Muzaffar Khan Medical & Children Hospital

    Wāh, Punjab Province, 44000

    Sehrish Noor, MS*, +923068989743, noor.sehrish14@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: Effect Of Multimodal Approach On Rehabilitation Of The Patient With Lateral Epicondylitis: A Randomized Controlled Trial

Literature is scarce for high quality evidence regarding multimodal rehabilitation in lateral epicondylitis. By making comparisons with the conventional treatment of patients with lateral epicondylitis, the current study aims to further establish the efficacy of the multimodal rehabilitation protocol through a RCT in order to generalize the results, using dynamometer as an additional tool for pre and post assessments against the outcome measures. Remarks A randomized control trial was conducted at Physical therapy departments of twin cities. The sample size was 40 calculated through G- power tool. The participants were divided into two interventional groups each having 20 participants. The study duration was eight months. Sampling technique applied was non- probability convience sampling. People of age 18-45 years, with localized point tenderness at lateral epicondyle with Mills, Cozen and Maudselys test positive were included in this research. Tools used in this study are Visual Analogue Scale, Dynamometer, Patient Rated Tennis Elbow Questionnaire. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 23.

Read the detailed description

Lateral epicondylitis is the most common lesion of the elbow complex. Despite also being referred to as "tennis elbow", lateral epicondylitis is present in less than 5-10 % of players and can appear in various tasks of excessive and repetitive effort involving movements gripping or pronation-supination.These specific patterned movements put manual laborers at the highest risk of developing lateral epicondylitis. Magnetic Resonance Imaging studies done to evaluate the prevalence of lateral epicondylitis suggest signal changes in the Extensor Carpi Radialis Brevis tendon consistent with lateral epicondylitis increase with age, with the incidence starting after 18 years of age and the peak prevalence in the subsequent decades of life. The cadaveric studies have established the direct contact of Extensor Carpi Radialis Brevis tendon with the elbow joint capsule, making it the epicondylar tendon bearing the greatest load in executing a backhand while playing tennis. Another study observed friction between the ECRB tendon and capitellum during flexion extension at the elbow joint. The Extensor Carpi Radialis Longus is the next most affected muscle in lateral epicondylitis since it has a tendon footprint 13 times greater than the Extensor Carpi Radialis Brevis on the epicondyle. As per the natural history of the lateral epicondylitis, it resolves spontaneously in 1-2 years without treatment. However, very few studies have compared outcomes with and without treatment. In a meta-analysis, no difference between nonoperative versus no treatment group was found for patients with lateral epicondylitis. One study reported no difference for the physiotherapy and corticosteroid groups compared to the wait-and-see group at 1 year against outcomes, while in another study the outcomes in the physiotherapy group were only slightly better. There are a number of different physiotherapy treatment options are available for lateral epicondylitis. However, literature is scarce for established efficacy of these treatments, largely due to lack of homogeneity as well as varied protocols of dosage and frequency. Nevertheless, these treatment options include but are not limited to stretching exercises, mobilization, electrotherapeutic modalities, deep transverse massage, orthoses, acupuncture, eccentric exercises and neuromuscular rehabilitation excercises etc. Neuromuscular rehabilitation can enhance grip strength by targeting both the muscles and the nervous system. It involves exercises that improve muscle coordination, motor control, and strength, which are crucial for a strong grip. Additionally, neuromuscular training can help re-establish proper firing patterns between the brain and muscles, leading to more efficient muscle recruitment and ultimately, improved grip strength. The treatment principle in most of these options is to reduce the force acting at the origin of the extensor muscles of the wrist allowing time for recovery to occur. The outcome reported as a result of the intervention is an improvement in pain, function and grip strength. As already stated, the available literature for the efficacy of conservative management of lateral epicondylitis cites lack of uniform results and therefore advocates for further research to establish the effect of these interventions. One such study by Marcolino et. al employed a multimodal rehabilitation protocol for lateral epicondylitis in a form of case series. This aim study aim at verifying "the efficiency of the multimodal treatment with mobilization with movement associated with eccentric strengthening, transverse massage and stretching in the treatment of eight volunteers with symptoms of lateral epicondylitis". According to this study, the results showed statistical differences in pain symptoms before and after treatment, in the analysis and functional assessment. However, lack of control group as well as the study design and the small sample size serve as confounding variables thereby limiting the ability of this study to generalize their findings. Furthermore, the study lacked objective evaluation for the assessment of grip strength. Therefore, the current study aims to work on the limitations of the study done by Marcolino et. al, by reducing the risk of biasness and eliminating the confounding variables. This will be done by conducting a randomized controlled trial in a larger sample size and comparing the suggested multimodal approach to the conventional protocol followed for lateral epicondylitis. Furthermore, in order to accurately measure the change in grip strength following the treatment protocol, dynamometer will be used.

Being tested
Multimodal physiotherapy, Conventional physiotherapy
Keywords
tennis elbow, manual therapy, multimodal treatment, hand strength
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal physiotherapyOther

    Experimental group included cold pack over lateral epicondyle. Passive stretching exercises in trapezius and levator scapulae and upper ECRB,ECRL,ECU,Extensor Digitorum, Extensor Digiti Minimi. Eccentric exercise of the extensor muscles associated with mobilization with movement. Neuromusclar Rehabilitation Excersise. In the region of origin of the tendons of the extensor muscles of the wrist and fingers for 2 min and inhibition of points of tension in the belly of the extensor region. Early mobilization with movement with the wrist in extension. Lateral sustained glide will be give at humeroradial joint during movement.

  • Conventional physiotherapyOther

    Control group included Cold pack for 10 mins on the lateral epicondylitis, Extensor carpi radialis brevis stretching (hold for 15 seconds x 4 reps) Active ROM of wrist flexion and extension (10 reps x 3 sets) Active ROM of elbow flexion, extension, supination and pronation (10 reps x 3 sets) . Manually resisting wrist extensors (10 second hold x 5 reps x 3 sets) 4 sets of Maitland elbow joint mobilization with 1 min of rest between sets. Baseline Dynamometer for grip strength and VAS for pain. These pre and post intervention values were mentioned in questionnaire. The participants were administered with the protocol and data was collected again immediately after the interventions without any delay.

Study groups in NCT06686732
Study groupRoleWhat they receive
Multimodal groupExperimentalExperimental group included cold pack over lateral epicondyle, Passive stretching exercises in cervical spine and upper limb. Eccentric exercise of the extensor muscles associated with mobilization with movement.Neuromusclar Rehabilitation Excersise. Inhibition of points of tension in the belly of the extensor region. Early mobilization with movement with the wrist in extension. Lateral sustained glide.
Receives: Other: Multimodal physiotherapy
Conventional physiotherapyActive comparatorControl group included Cold pack, Extensor carpi radialis brevis stretching. Active ROM of wrist flexion and extension. Active ROM of elbow flexion, extension, supination and pronation. Manually resisting wrist extensors. Maitland elbow joint mobilization with 1 min of rest between sets.
Receives: Other: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grip Strength

    Changes from Baseline grip strength were taken with the help of dynamomter that measures grip strength.

    Measured: Three Weeks

Secondary outcomes (2)
  1. Visual Analogue Scale

    Changes from the baseline pain levelesthe basis were measured through visual analogue scale.

    Measured: Three Weeks

  2. Patient Rated Tennis Elbow Questionnaire

    Changes in the functional Activities were noted through Patient Rated Tennis Elbow Questionnaire from the baseline and post treatment readings.

    Measured: Three Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start3 May 2024
  3. Primary completion3 Dec 2024 (estimated)
  4. Study completion13 Dec 2024 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686732
Sponsor's protocol ID
Riphah/RCRAHS/REC/MS-PT/01939
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal physiotherapy and Conventional physiotherapy in people with Lateral Epicondylitis, run by Riphah International University at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, PhD (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grip Strength (time frame: Three Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Nov 2024.

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