Lateral epicondylitis Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. Able to communicate in English 3. Self-reported diagnosis of LE accompanied by the following symptoms: 3.1. Pain on the lateral side of the elbow elicited by resisted wrist extension 3.2. Tenderness at the lateral epicondyle 3.3. Measurable loss in composite muscle flexibility (extensibility) 3.4. Symptoms persisting for at least 12 weeks
Exclusion criteria
Exclusion criteria: 1. Had a steroid injection for LE within the past three months: Steroid injections are a treatment for LE and could confound the study results. 2. Had undergone previous surgery for LE: Approximately 10% of post-surgical cases remain symptomatic, suggesting severe LE or underlying conditions unrelated to this study. 3. Had been diagnosed with elbow, wrist, or finger arthritis. 4. Sensory and/or motor changes distal to the elbow, such as carpal tunnel syndrome or elbow joint instability. 5. Pain associated with radiculopathy, cervical nerve compression or thoracic outlet syndrome. 6. Practice high-velocity racquet sports, such as tennis or badminton. 7. Exhibited a difference of less than 15 degrees in the range of motion (ROM) of wrist flexion with fingers extended compared to fingers flexed: Such cases indicate limited capacity for further mechanical stretching using the ArmLock Sleeve. 8. Experienced pain during ligament stress tests at the elbow: This pain may indicate ligament instability, precluding safe use of the device. 9. Had a wound or scarring in the area where the ArmLock Sleeve would be applied: These conditions could prevent proper application and pose risks to healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain-free grip strength (PFG), defined as the maximum force a person can apply during a gripping action without experiencing pain. This objective measure was recorded in pounds (lb) using a hydraulic dynamometer. It was measured at baseline, weeks 6, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite extensibility of wrist and finger extensor muscles: this measure reflects the overall flexibility of the wrist and finger extensor muscles. It is an objective indicator of muscle tightness, recorded in degrees using a goniometer. It was measured at baseline, weeks 6, and 12. 2. Pressure pain threshold (PPT): the pressure pain threshold refers to the minimum amount of pressure needed to produce pain. It is an objective measure assessed with a digital algometer and recorded in pounds (lb). It was measured at baseline, weeks 6, and 12. 3. Pain during resisted wrist extension (2 lb test): this subjective outcome captures the level of pain experienced while lifting a 2 lb weight during a resisted wrist extension. Participants rated their pain on a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). It was measured at baseline, weeks 6, and 12. 4. Self-Reported pain and functional disability: pain and functional limitations were assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE), a 15-item self-report questionnaire consisting of two subscales: one for pain (5 items) and one for functional disability (10 items). The functional section includes items on specific daily tasks and general activities. Each subscale is scored from 0 to 100, with higher scores indicating greater symptom severity. The pain subscale, functional subscale, and total score were used as outcome variables. These were measured at baseline, weeks 6, and 12. | — |
Countries
Canada