Lateral EpicondylitisNCT06735092
Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects
A study testing Exercise-Only Group, Exercise + Forearm Counterforce Brace Group and Exercise + Wrist Orthosis Group in people with Lateral Epicondylitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate whether adding a forearm counterforce brace or a wrist orthosis to exercise therapy provided additional benefits in pain, functional status, grip strength, and perceived recovery in individuals with lateral elbow tendinopathy, compared with exercise therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Exercise-Only Group, Exercise + Forearm Counterforce Brace Group and Exercise + Wrist Orthosis Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to 30 Aug 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 65,
- Having a diagnosis of unilateral lateral elbow tendinopathy,
- Having at least two of the Thomsen, Maudsley, Mill's, or Cozen's tests positive during clinical examination,
- Experiencing symptoms for at least 3 months,
- Not having a systemic or chronic illness that would prevent participation in the treatment program.
Who cannot join
- A history of trauma or surgery in the relevant elbow and/or wrist,
- The presence of orthopedic and/or neurological problems in the cervical spine, shoulder joint, or wrist,
- Participation in a physiotherapy and rehabilitation program for lateral elbow tendinopathy within the last 6 months,
- Receiving any injections within the last 6 months,
- Systemic inflammatory disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Istanbul University - Cerrahpasa
Istanbul, Buyukcekmece, 34500
About this study
Official title: Investigation of the Effects of Different Types of Orthoses Used in Addition to Exercise Therapy in Lateral Elbow Tendinopathy
The aim of this study was to investigate whether adding a forearm counterforce brace or a wrist orthosis to exercise therapy provided additional benefits in pain, functional status, grip strength, and perceived recovery in individuals with lateral elbow tendinopathy, compared with exercise therapy alone.
Read the detailed description
This study was conducted under the supervision of Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. It was designed as a single-centre, three-arm randomized controlled trial and included adults with unilateral lateral elbow tendinopathy who met the eligibility criteria and provided written informed consent. Participants were recruited from the Orthopedics and Traumatology Clinic of Basaksehir Cam and Sakura City Hospital. Participants were informed about the purpose, procedures, and potential risks of the study, and written informed consent was obtained from all participants. Following informed consent, 45 participants were randomly allocated in a 1:1:1 ratio to three groups:
- Exercise-Only Group
- Exercise + Counterforce Forearm Brace Group
- Exercise + Wrist Orthosis Group
All participants received education, activity modification, and the same physiotherapist-led progressive exercise program. Supervised exercise sessions were conducted twice weekly for 6 weeks, followed by a 6-week home exercise program. The exercise program consisted of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights according to individual tolerance, with progression achieved through 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next resistance level. Participants in Group 2 additionally used a counterforce forearm brace, whereas participants in Group 3 additionally used a wrist orthosis.
Participants were assessed at baseline, week 6, and week 12. The primary outcome was the Patient-Rated Tennis Elbow Evaluation (PRTEE). Secondary outcomes included resting and activity pain assessed using the Numeric Pain Rating Scale (NPRS), pain-free and maximum grip strength measured using a digital hand dynamometer, and perceived recovery assessed using the Global Rating of Change (GRC) scale. Sociodemographic and clinical characteristics were recorded using a case assessment form.
The collected data were analyzed using the Statistical Package for the Social Sciences (SPSS).
- Conditions
- Lateral Epicondylitis
- Being tested
- Exercise-Only Group, Exercise + Forearm Counterforce Brace Group, Exercise + Wrist Orthosis Group
- Keywords
- Exercise Therapy, Rehabilitation, Orthotic Devices, Pain, Tendinopathy
- Medical subject headings
- Tennis Elbow, Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Only GroupOther
Participants in this group received a standardized exercise protocol. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. Participants were assessed at baseline, week 6, and week 12.
Exercise + Forearm Counterforce Brace GroupOther
Participants in this group received a standardized exercise protocol and a counterforce forearm brace in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The counterforce forearm brace was positioned approximately 2.5 cm distal to the lateral epicondyle and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the brace during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.
Exercise + Wrist Orthosis GroupOther
Participants in this group received a standardized exercise protocol and a wrist orthosis in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The wrist orthosis maintained the wrist in slight extension and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the orthosis during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-Only Group | Active comparator | This was the exercise-only group, in which participants received an exercise program without any additional support or devices such as braces. This group was used to assess the effectiveness of exercise alone compared with other interventions involving braces. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. Receives: Other: Exercise-Only Group |
| Exercise + Forearm Counterforce Brace Group | Active comparator | This group received a combined treatment approach, including exercise therapy alongside the use of a forearm counterforce brace. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. Receives: Other: Exercise + Forearm Counterforce Brace Group |
| Exercise + Wrist Orthosis Group | Active comparator | This group received a treatment combining exercise therapy with the use of a wrist orthosis. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. Receives: Other: Exercise + Wrist Orthosis Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-reported questionnaire designed to measure pain and functional limitations in individuals with lateral epicondylitis (tennis elbow). It consists of 15 items divided into two subscales: pain (5 items) and functional disability (10 items). Each item is rated on a scale from 0 (no pain or difficulty) to 10 (severe pain or difficulty), with a total score range of 0 to 100. Higher scores indicate greater pain and disability, while lower scores reflect improvement. The PRTEE is commonly used to assess treatment outcomes and track patient progress over time.
Measured: Baseline, week 6, week 12; primary endpoint = week 12
Secondary outcomes (5)
Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])
The Numeric Pain Rating Scale (NPRS) is a subjective measure used to assess pain intensity. It is a 0-10 scale, where 0 indicates "no pain" and 10 represents "the worst pain imaginable." Patients are asked to rate their pain level at rest during the previous 24 hours based on this scale. A decrease in the NPRS score indicates an improvement or reduction in pain, while an increase suggests worsening pain. It is a simple and widely used tool for monitoring pain in clinical and research settings.
Measured: Baseline, week 6, week 12
Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])
The Numeric Pain Rating Scale (NPRS) is a subjective measure used to assess pain intensity. It is a 0-10 scale, where 0 indicates "no pain" and 10 represents "the worst pain imaginable." Patients are asked to rate their pain level during activity based on this scale. A decrease in the NPRS score indicates an improvement or reduction in pain, while an increase suggests worsening pain. It is a simple and widely used tool for monitoring pain in clinical and research settings.
Measured: Baseline, week 6, week 12
Pain-Free Grip Strength
Pain-free grip strength is a measure of grip force that can be exerted without provoking pain. It was assessed using a digital hand dynamometer. Participants were instructed to gradually increase their grip force until they first experienced pain, and the grip force at that point was recorded. An increase in pain-free grip strength indicates an improvement in grip performance and pain tolerance.
Measured: Baseline, week 6, week 12
Maximum Grip Strength
Maximum grip strength is a measure of the maximum force that can be generated during a grip. It was assessed using a digital hand dynamometer. Participants were instructed to squeeze the dynamometer as strongly as possible, and the maximum grip force was recorded. An increase in maximum grip strength indicates an improvement in grip performance.
Measured: Baseline, week 6, week 12
Global Rating of Change (GRC)
The Global Rating of Change (GRC) scale is a subjective measure used to assess patients' perceived change in their condition following treatment. Participants compare their current condition with their condition before treatment and rate their perceived change. In this study, the GRC was used to assess patients' perceived recovery at weeks 6 and 12. For analysis, responses were categorized as unchanged, better, or much better.
Measured: Week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start2 Dec 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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 Istanbul University - CerrahpasaThe 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
- Model description
- This study involves three groups with exercise therapy: one with exercise only, one with exercise in addition to a counterforce forearm brace, and one with exercise in addition to a wrist orthosis.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kültür, Istanbul University - Cerrahpasa
- Investigators
- Büşra Kültür, MSc, Principal investigator, Istanbul University - CerrahpasaDerya Çelik, Prof. Dr., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735092
- Sponsor's protocol ID
- IstanbulUC-FTR-B-01
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2024
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Types of Orthoses Used in Addition to Exercise Therapy in Lateral Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT06735092
- Acronym / sponsor ID
- IstanbulUC-FTR-B-01
- Conditions
- Lateral Epicondylitis
- Keywords
- Exercise Therapy, Rehabilitation, Orthotic Devices, Pain, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 16 Dec 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.
The aim of this study was to investigate whether adding a forearm counterforce brace or a wrist orthosis to exercise therapy provided additional benefits in pain, functional status, grip strength, and perceived recovery in individuals with lateral elbow tendinopathy, compared with exercise therapy alone.
Detailed description
This study was conducted under the supervision of Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. It was designed as a single-centre, three-arm randomized controlled trial and included adults with unilateral lateral elbow tendinopathy who met the eligibility criteria and provided written informed consent. Participants were recruited from the Orthopedics and Traumatology Clinic of Basaksehir Cam and Sakura City Hospital. Participants were informed about the purpose, procedures, and potential risks of the study, and written informed consent was obtained from all participants. Following informed consent, 45 participants were randomly allocated in a 1:1:1 ratio to three groups:
- Exercise-Only Group
- Exercise + Counterforce Forearm Brace Group
- Exercise + Wrist Orthosis Group
All participants received education, activity modification, and the same physiotherapist-led progressive exercise program. Supervised exercise sessions were conducted twice weekly for 6 weeks, followed by a 6-week home exercise program. The exercise program consisted of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights according to individual tolerance, with progression achieved through 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next resistance level. Participants in Group 2 additionally used a counterforce forearm brace, whereas participants in Group 3 additionally used a wrist orthosis.
Participants were assessed at baseline, week 6, and week 12. The primary outcome was the Patient-Rated Tennis Elbow Evaluation (PRTEE). Secondary outcomes included resting and activity pain assessed using the Numeric Pain Rating Scale (NPRS), pain-free and maximum grip strength measured using a digital hand dynamometer, and perceived recovery assessed using the Global Rating of Change (GRC) scale. Sociodemographic and clinical characteristics were recorded using a case assessment form.
The collected data were analyzed using the Statistical Package for the Social Sciences (SPSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study involves three groups with exercise therapy: one with exercise only, one with exercise in addition to a counterforce forearm brace, and one with exercise in addition to a wrist orthosis.
| Arm | Type | Receives |
|---|---|---|
| Exercise-Only Group | Active comparator | Other: Exercise-Only GroupThis was the exercise-only group, in which participants received an exercise program without any additional support or devices such as braces. This group was used to assess the effectiveness of exercise alone compared with other interventions involving braces. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. |
| Exercise + Forearm Counterforce Brace Group | Active comparator | Other: Exercise + Forearm Counterforce Brace GroupThis group received a combined treatment approach, including exercise therapy alongside the use of a forearm counterforce brace. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. |
| Exercise + Wrist Orthosis Group | Active comparator | Other: Exercise + Wrist Orthosis GroupThis group received a treatment combining exercise therapy with the use of a wrist orthosis. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18 and 65,
- Having a diagnosis of unilateral lateral elbow tendinopathy,
- Having at least two of the Thomsen, Maudsley, Mill's, or Cozen's tests positive during clinical examination,
- Experiencing symptoms for at least 3 months,
- Not having a systemic or chronic illness that would prevent participation in the treatment program.
Key exclusion criteria (5 listed)
- A history of trauma or surgery in the relevant elbow and/or wrist,
- The presence of orthopedic and/or neurological problems in the cervical spine, shoulder joint, or wrist,
- Participation in a physiotherapy and rehabilitation program for lateral elbow tendinopathy within the last 6 months,
- Receiving any injections within the last 6 months,
- Systemic inflammatory disease.
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 |
|---|---|---|
| Exercise-Only GroupParticipants in this group received a standardized exercise protocol. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. Participants were assessed at baseline, week 6, and week 12. | Other | Exercise-Only Group |
| Exercise + Forearm Counterforce Brace GroupParticipants in this group received a standardized exercise protocol and a counterforce forearm brace in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The counterforce forearm brace was positioned approximately 2.5 cm distal to the lateral epicondyle and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the brace during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12. | Other | Exercise + Forearm Counterforce Brace Group |
| Exercise + Wrist Orthosis GroupParticipants in this group received a standardized exercise protocol and a wrist orthosis in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The wrist orthosis maintained the wrist in slight extension and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the orthosis during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12. | Other | Exercise + Wrist Orthosis Group |
Primary outcome
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
Time frame: Baseline, week 6, week 12; primary endpoint = week 12
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-reported questionnaire designed to measure pain and functional limitations in individuals with lateral epicondylitis (tennis elbow). It consists of 15 items divided into two subscales: pain (5 items) and functional disability (10 items). Each item is rated on a scale from 0 (no pain or difficulty) to 10 (severe pain or difficulty), with a total score range of 0 to 100. Higher scores indicate greater pain and disability, while lower scores reflect improvement. The PRTEE is commonly used to assess treatment outcomes and track patient progress over time.
5 secondary outcomes
Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])
Time frame: Baseline, week 6, week 12
Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])
Time frame: Baseline, week 6, week 12
Pain-Free Grip Strength
Time frame: Baseline, week 6, week 12
Maximum Grip Strength
Time frame: Baseline, week 6, week 12
Global Rating of Change (GRC)
Time frame: Week 6, week 12
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 20 Aug 2026.
- 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.
Büşra Kültür, MSc principal investigator
Istanbul University - Cerrahpasa
Derya Çelik, Prof. Dr. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-Only Group, Exercise + Forearm Counterforce Brace Group and Exercise + Wrist Orthosis Group in people with Lateral Epicondylitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 20 Aug 2026. 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 Turkey (Türkiye). 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?
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE) (time frame: Baseline, week 6, week 12; primary endpoint = week 12). 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 20 Aug 2026.