Lateral Epicondylitis
Conditions
Keywords
Exercise Therapy, Rehabilitation, Orthotic Devices, Pain, Tendinopathy
Brief 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.
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: 1. Exercise-Only Group 2. Exercise + Counterforce Forearm Brace Group 3. 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).
Interventions
OTHERExercise-Only Group
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.
OTHERExercise + Forearm Counterforce Brace Group
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.
OTHERExercise + Wrist Orthosis Group
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.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study was an open-label randomized controlled trial. Participants and treating physiotherapists were not blinded to group allocation due to the nature of the interventions. The outcome assessor was blinded to group allocation and performed all baseline and follow-up measurements.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change (GRC) | Week 6, week 12 | 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. |
| Resting Pain Intensity (Numeric Pain Rating Scale [NPRS]) | Baseline, week 6, week 12 | 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. |
| Activity Pain Intensity (Numeric Pain Rating Scale [NPRS]) | Baseline, week 6, week 12 | 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. |
| Pain-Free Grip Strength | Baseline, week 6, week 12 | 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. |
| Maximum Grip Strength | Baseline, week 6, week 12 | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORBüşra Kültür, MSc
Istanbul University - Cerrahpasa
STUDY_DIRECTORDerya Çelik, Prof. Dr.
Istanbul University - Cerrahpasa
Outcome results
None listed