Lateral EpicondylitisNCT05696327
Eccentric Tyler Twist Wrist Extensor Strengthening in Lateral Epicondylitis
A study testing Tyler Twist Exercises and conventional physical therapy in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effects of Tyler twist wrist extensor strengthening exercises in patients with lateral epicondylitis. A randomized control trial was conducted at Cina medical center Rawalpindi and Midland Doctors Medical institute. The sample size was 52 calculated through open-epi tool. 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?
- Tyler Twist Exercises and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 20 Jan 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 genders (male and female)
- Age between 20yrs-40yrs
- Tenderness on palpation over the lateral epicondyle of humerus.
- Pain with gripping.
- Pain with resisted wrist extension.
- clinically diagnosed patients of lateral epicondylitis
- did not take any kind of physiotherapy treatment.
Who cannot join
- cervical spine disorder.
- Peripheral neuropathy.
- Previous Fracture/ trauma or surgery to the elbow region.
- Steroid injections in last 6 months.
- Tumor or wound.
- Any other systemic/autoimmune disorders or congenital Participants who received any therapy for lumbar region past 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Eccentric Tyler Twist Extensor Strengthening Exercises in Lateral Epicondylitis
The purpose of the study is to compare the effects of Tyler twist wrist extensor strengthening exercises in patients with lateral epicondylitis. A randomized control trial was conducted at Cina medical center Rawalpindi and Midland Doctors Medical institute. The sample size was 52 calculated through open-epi tool. The participants were divided into two groups: the treatment group and the control group. The study duration was 1 year. Sampling technique applied was non-probability purposive sampling. Only 20 to 40 years participants with diagnosed condition were included in the study. Tools used in this study are Jamar dynamometer for grip strength and PRTEE Questionnaire for pain and disability. Data was collected at baseline, mid and immediately after the application of interventions. Data analyzed through SPSS version 25
Read the detailed description
Lateral epicondylitis is the most common cause of pain in elbow, due to repetitive wrist extension or gripping activities. This condition is also described as a chronic symptomatic degeneration of the extensor tendon of forearm commonly extensor carpi radialis brevis at the attachment area of humeral epicondyle. (1) Tennis elbow is common in individuals who undergo repetitive wrist extension, radial deviation, and forearm supination. The histological findings of lateral epicondylitis consist of granulation tissue, micro-rupture, fibroblasts abundance, UN structured collagen, vascular hyperplasia, and lack of inflammatory cells within the tissue (lymphocytes, macrophages, neutrophils). (2) Lateral epicondylitis can occur in any age group but is more common between 30-50 years of age. (3) Many previous reports conducted in different countries described that there is 2-14% prevalence of lateral epicondylitis in working population and only 5% of people suffering from tennis elbow relate this injury to the tennis. (4) Evidence from a systematic review published in 2019 described the prevalence rate of 1-3% in the general population and 7% in the handy workers group with equal gender distribution. (5) There are many treatment options for lateral epicondylitis. Initially it is treated by conservative treatment (1) Recently in 2021, R Manandhar et al conducted an RCT reported positive results using combination of Movement with mobilization and Eccentric exercises regarding pain and functional disability.(8) BL Woodley et al in 2018 published his systematic review which concluded that limited level of evidence exists on the effectiveness of eccentric strengthening exercises to standard physiotherapy protocols. Twenty relevant studies were sourced, 11 of which met the inclusion criteria. These included studies of tendinopathy of the common wrist extensor tendon of the lateral elbow (LET. (9) If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.(6) In an RCT of Ju-hyun Lee et all in 2018 ,the effects of eccentric control exercise for tennis elbow showed useful effects for pain and functional activity was improved with a p value of 0.05.(7) Timothy Tyler et al recently conducted a cross sectional study in 2021 to compare standard physiotherapy treatment to Tyler twist exercises which are a new treatment protocol for wrist extensor strengthening using 2-3 colored twistable rubber bands This study suggested that Tyler twist exercise could be effective strength training protocol and once learnt can be performed by the patient at home without any supervision.(9)
To treat lateral epicondylitis platelet rich plasma has gained popularity. To enhance wound healing, bone healing and tendon healing, platelets release high concentration of platelet-derived growth factors. It is difficult to draw clear conclusions on PRP for lateral epicondylitis because some available studies have reported conflicting results. Manipulative techniques fall into two basic varieties in the treatment of lateral epicondylitis; those that will produce a thrust and those that seek full extension. To effect the contractile element the manipulations performed in extension with pronation have the greatest chance. Forced extension of elbow with the wrist and fingers fixed and the forearm promoted is the most common procedure known as mill's manipulation. Manipulations are painful procedures and require 2 weeks of rest after application.(11) With a high success rate, injections are one of the most popular methods utilized .Physical therapy is initiated when the condition becomes chronic or not responding to initial treatment. Ultrasound, phonophoresis, electrical stimulation,, manipulation, soft tissue mobilization , neural tension, friction massage , augmented soft tissue mobilization and stretching and strengthening techniques are the common rehabilitation modalities utilized for the treatment. (12) Proper evidence behind Tyler twist wrist extensor exercises in the management of lateral epicondylitis is sparse and there are less number of studies with limited methodological designs. There are no previous randomized control trials conducted to see the effects of Tyler twist exercises in contrast to standard physiotherapy treatment using combined tools for pain , grip strength and functional activity According to the literature review, there had been lack of reporting of compliance and adherence to the exercise programs, with only four studies documenting exercise adherence, So, the additional benefit of this protocol is that it can be performed as part of a home program and does not involve continued medical supervision when learned properly. So, this study will focus on effects of Tyler twist exercise to standard physiotherapy protocol.
- Conditions
- Lateral Epicondylitis
- Being tested
- Tyler Twist Exercises, conventional physical therapy
- Keywords
- Lateral Epicondylitis, Tyler Twist Exercises, Elbow
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyler Twist ExercisesOther
Tyler twist exercises are the group of exercises which are used to strengthen wrist ex tensors.The protocol consists of several steps using colored twist-able bands and patients are guided to actively perform the steps for their grip strength development.
conventional physical therapyOther
Also called control group
Conventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | tyler twist wrist extensor strengthening exercises Treatment protocol will be followed for thrice a week for 4 weeks. The session will be of approximately 20 minutes. The initial Conventional therapy program will be the same as discussed in the control group except strengthening exercise which is excluded in experimental group because of Tyler twist exercise which is being used as a strengthening protocol. Receives: Other: Tyler Twist Exercises |
| Control Group | Active comparator | Conventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.) The treatment will continue for 4 weeks and 3 sessions/ week i.e. thrice a week. The session will be of approximately 20 minutes. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand held dynamo-meter(Grip strength)
To measure grip strength, Hand held dyanamo-meter is used as a tool to record readings in Kg.The device is hand held and displays grip force with a maximum range of 90kg.Maximum 3 readings are recorded and then a mean is calculated which is an actual value to be noted.Male to female ratio varies for the grip strengths and ranges from 35kg max in females and 60kg in male population.Strength also varies in old population as well.
Measured: upto 24 weeks
Secondary outcomes (1)
Patient rated tennis elbow evaluation questionnaire(PRTEE)
Pain and disability are the two variables which are measured using PRTEE(Patient rated tennis elbow evaluation questionnaire). The questionnaire consists of 3 portions :(Pain , Functional disability usual activities and functional disability specific activities ,Total score ). To measure forearm pain and disability , this 15 item assessment tool is used to record the readings(Baseline , mid and post interventional assessments) .
Measured: upto 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Feb 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696327
- Sponsor's protocol ID
- Riphah/RCRS/01222 Rimsha Jalil
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Tyler Twist Extensor Strengthening Exercises in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05696327
- Acronym / sponsor ID
- Riphah/RCRS/01222 Rimsha Jalil
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Tyler Twist Exercises, Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 25 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 purpose of the study is to compare the effects of Tyler twist wrist extensor strengthening exercises in patients with lateral epicondylitis. A randomized control trial was conducted at Cina medical center Rawalpindi and Midland Doctors Medical institute. The sample size was 52 calculated through open-epi tool. The participants were divided into two groups: the treatment group and the control group. The study duration was 1 year. Sampling technique applied was non-probability purposive sampling. Only 20 to 40 years participants with diagnosed condition were included in the study. Tools used in this study are Jamar dynamometer for grip strength and PRTEE Questionnaire for pain and disability. Data was collected at baseline, mid and immediately after the application of interventions. Data analyzed through SPSS version 25
Detailed description
Lateral epicondylitis is the most common cause of pain in elbow, due to repetitive wrist extension or gripping activities. This condition is also described as a chronic symptomatic degeneration of the extensor tendon of forearm commonly extensor carpi radialis brevis at the attachment area of humeral epicondyle. (1) Tennis elbow is common in individuals who undergo repetitive wrist extension, radial deviation, and forearm supination. The histological findings of lateral epicondylitis consist of granulation tissue, micro-rupture, fibroblasts abundance, UN structured collagen, vascular hyperplasia, and lack of inflammatory cells within the tissue (lymphocytes, macrophages, neutrophils). (2) Lateral epicondylitis can occur in any age group but is more common between 30-50 years of age. (3) Many previous reports conducted in different countries described that there is 2-14% prevalence of lateral epicondylitis in working population and only 5% of people suffering from tennis elbow relate this injury to the tennis. (4) Evidence from a systematic review published in 2019 described the prevalence rate of 1-3% in the general population and 7% in the handy workers group with equal gender distribution. (5) There are many treatment options for lateral epicondylitis. Initially it is treated by conservative treatment (1) Recently in 2021, R Manandhar et al conducted an RCT reported positive results using combination of Movement with mobilization and Eccentric exercises regarding pain and functional disability.(8) BL Woodley et al in 2018 published his systematic review which concluded that limited level of evidence exists on the effectiveness of eccentric strengthening exercises to standard physiotherapy protocols. Twenty relevant studies were sourced, 11 of which met the inclusion criteria. These included studies of tendinopathy of the common wrist extensor tendon of the lateral elbow (LET. (9) If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.(6) In an RCT of Ju-hyun Lee et all in 2018 ,the effects of eccentric control exercise for tennis elbow showed useful effects for pain and functional activity was improved with a p value of 0.05.(7) Timothy Tyler et al recently conducted a cross sectional study in 2021 to compare standard physiotherapy treatment to Tyler twist exercises which are a new treatment protocol for wrist extensor strengthening using 2-3 colored twistable rubber bands This study suggested that Tyler twist exercise could be effective strength training protocol and once learnt can be performed by the patient at home without any supervision.(9)
To treat lateral epicondylitis platelet rich plasma has gained popularity. To enhance wound healing, bone healing and tendon healing, platelets release high concentration of platelet-derived growth factors. It is difficult to draw clear conclusions on PRP for lateral epicondylitis because some available studies have reported conflicting results. Manipulative techniques fall into two basic varieties in the treatment of lateral epicondylitis; those that will produce a thrust and those that seek full extension. To effect the contractile element the manipulations performed in extension with pronation have the greatest chance. Forced extension of elbow with the wrist and fingers fixed and the forearm promoted is the most common procedure known as mill's manipulation. Manipulations are painful procedures and require 2 weeks of rest after application.(11) With a high success rate, injections are one of the most popular methods utilized .Physical therapy is initiated when the condition becomes chronic or not responding to initial treatment. Ultrasound, phonophoresis, electrical stimulation,, manipulation, soft tissue mobilization , neural tension, friction massage , augmented soft tissue mobilization and stretching and strengthening techniques are the common rehabilitation modalities utilized for the treatment. (12) Proper evidence behind Tyler twist wrist extensor exercises in the management of lateral epicondylitis is sparse and there are less number of studies with limited methodological designs. There are no previous randomized control trials conducted to see the effects of Tyler twist exercises in contrast to standard physiotherapy treatment using combined tools for pain , grip strength and functional activity According to the literature review, there had been lack of reporting of compliance and adherence to the exercise programs, with only four studies documenting exercise adherence, So, the additional benefit of this protocol is that it can be performed as part of a home program and does not involve continued medical supervision when learned properly. So, this study will focus on effects of Tyler twist exercise to standard physiotherapy protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Tyler Twist Exercisestyler twist wrist extensor strengthening exercises Treatment protocol will be followed for thrice a week for 4 weeks. The session will be of approximately 20 minutes. The initial Conventional therapy program will be the same as discussed in the control group except strengthening exercise which is excluded in experimental group because of Tyler twist exercise which is being used as a strengthening protocol. |
| Control Group | Active comparator | Other: conventional physical therapyConventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.) The treatment will continue for 4 weeks and 3 sessions/ week i.e. thrice a week. The session will be of approximately 20 minutes. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- both genders (male and female)
- Age between 20yrs-40yrs
- Tenderness on palpation over the lateral epicondyle of humerus.
- Pain with gripping.
- Pain with resisted wrist extension.
Key exclusion criteria (6 listed)
- cervical spine disorder.
- Peripheral neuropathy.
- Previous Fracture/ trauma or surgery to the elbow region.
- Steroid injections in last 6 months.
- Tumor or wound.
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 |
|---|---|---|
| Tyler Twist ExercisesTyler twist exercises are the group of exercises which are used to strengthen wrist ex tensors.The protocol consists of several steps using colored twist-able bands and patients are guided to actively perform the steps for their grip strength development. | Other | Experimental Group |
| conventional physical therapyAlso: control groupConventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.) | Other | Control Group |
Primary outcome
Hand held dynamo-meter(Grip strength)
Time frame: upto 24 weeks
To measure grip strength, Hand held dyanamo-meter is used as a tool to record readings in Kg.The device is hand held and displays grip force with a maximum range of 90kg.Maximum 3 readings are recorded and then a mean is calculated which is an actual value to be noted.Male to female ratio varies for the grip strengths and ranges from 35kg max in females and 60kg in male population.Strength also varies in old population as well.
1 secondary outcome
Patient rated tennis elbow evaluation questionnaire(PRTEE)
Time frame: upto 24 weeks
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 10 Jul 2023.
- 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.
Lal Gul Khan, MScPT 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 Tyler Twist Exercises and conventional physical therapy 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 7 inclusion and 6 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 10 Jul 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?
Hand held dynamo-meter(Grip strength) (time frame: upto 24 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 10 Jul 2023.