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.
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
- 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
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.
- Conditions
- Lateral Epicondylitis
- 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 group | Role | What they receive |
|---|---|---|
| Multimodal group | Experimental | Experimental 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 physiotherapy | Active comparator | Control 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.
Grip Strength
Changes from Baseline grip strength were taken with the help of dynamomter that measures grip strength.
Measured: Three Weeks
Secondary outcomes (2)
Visual Analogue Scale
Changes from the baseline pain levelesthe basis were measured through visual analogue scale.
Measured: Three Weeks
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.
- First posted13 Nov 2024
- Study start3 May 2024
- Primary completion3 Dec 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, MS*, Principal investigator, Riphah International University, Islamabad
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Multimodal Approach On Rehabilitation Of The Patient With Lateral Epicondylitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06686732
- Acronym / sponsor ID
- Riphah/RCRAHS/REC/MS-PT/01939
- Conditions
- Lateral Epicondylitis
- Keywords
- tennis elbow, manual therapy, multimodal treatment, hand strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 13 Nov 2024 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal group | Experimental | Other: Multimodal physiotherapyExperimental 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. |
| Conventional physiotherapy | Active comparator | Other: Conventional physiotherapyControl 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Multimodal physiotherapyExperimental 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. | Other | Multimodal group |
| Conventional physiotherapyControl 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. | Other | Conventional physiotherapy |
Primary outcome
Grip Strength
Time frame: Three Weeks
Changes from Baseline grip strength were taken with the help of dynamomter that measures grip strength.
2 secondary outcomes
Visual Analogue Scale
Time frame: Three Weeks
Patient Rated Tennis Elbow Questionnaire
Time frame: Three Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- 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.
Ramsha Tariq, MS* principal investigator
Riphah International University, Islamabad
3 sites in 1 country: see every site and its status.
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.