Measuring the effectiveness of a novel treatment of chronic tennis elbow: the ArmLock sleeve
| ISRCTN | ISRCTN13309889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13309889 |
| Secondary identifying numbers | RES0046927 |
- Submission date
- 04/04/2025
- Registration date
- 09/04/2025
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Tennis elbow, or lateral epicondylitis (LE), is a condition that causes pain in the elbow, especially during wrist and hand movements. This pain can interfere with daily activities like dressing, lifting, or typing. The purpose of this study was to test a new device called the ArmLock Sleeve, which gently stretches the muscles that contribute to tennis elbow. The study aimed to find out if using this sleeve could reduce pain and improve arm function.
Who can participate?
Patients aged 18 years and over diagnosed with tennis elbow who met the study's inclusion criteria were invited to participate.
What does the study involve?
Participants wore the ArmLock Sleeve at home for 30 minutes each day over a 12-week period. They visited the lab three times at the beginning, at week 6, and at the end of the study to complete assessments of pain, grip strength, and arm mobility.
What are the possible benefits and risks of participating?
Some participants experienced reduced pain and improved arm function. The study also helps researchers learn more about non-surgical treatments for tennis elbow. However, there were some risks. Participants may have experienced temporary pain or discomfort during testing or from wearing the sleeve. The research team was prepared to stop any procedure if the participant felt too much discomfort.
Where is the study run from?
All in-person assessments took place at Lab 1-45 in Corbett Hall at the University of Alberta (Canada). Participants used the ArmLock Sleeve at home.
When is the study starting and how long is it expected to run for?
February 2020 to April 2023
Who is funding the study?
The study was funded by the Mathematics of Information Technology and Complex Systems (Mitacs) Accelerate Program (Canada)
Who is the main contact?
Dr Adriana Rios Rincón, aros@ualberta.ca
Contact information
Public, Principal Investigator
8205 - 114 Street 2-10 Corbett Hall
Edmonton
T6G 2G4
Canada
 ORCID ID |
0000-0002-9018-9761 |
|---|---|
| Phone | +1 (0)7804925150 |
| aros@ualberta.ca |
Scientific
8205 - 114 Street, 2-08 Corbett Hall
Edmonton
T6G 2G4
Canada
| ORCID ID |
0000-0003-1618-8733 |
|---|---|
| Phone | +1 (0)7804926104 |
| miguelcr@ualberta.ca |
Study information
| Study design | Multimethod design: a one-way repeated measures design over time was used to address research objective one and a qualitative description design and descriptive study design were used to address research objective two |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Within-subjects repeated measures design |
| Study setting(s) | Community, University/medical school/dental school |
| Study type | Efficacy |
| Scientific title | Measuring the effectiveness of a novel treatment of chronic lateral epicondylitis: the ArmLock sleeve |
| Study objectives | Primary Hypothesis: Wearing the ArmLock Sleeve for 30 minutes daily over a 12-week period will significantly reduce pain and functional disability in individuals with lateral epicondylitis. Secondary Hypothesis: The sustained positioning provided by the ArmLock Sleeve will significantly improve the extensibility of wrist and finger extensor muscles and increase pain-free grip strength in individuals with lateral epicondylitis. |
| Ethics approval(s) |
Approved 11/02/2020, Health Research Ethics Board - Health Panel (308 Campus Tower 8625 112 Street NW, Edmonton, T6G 1K8, Canada; +1 (0)780 492 0459; ethics@ualberta.ca), ref: Pro00095330 |
| Health condition(s) or problem(s) studied | Lateral epicondylitis |
| Intervention | ArmLock sleeve. Participants were instructed to wear the device for 30 minutes daily over a 12-week period as an intervention to treat lateral epicondylitis. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 11/02/2020 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 33 |
| Total final enrolment | 19 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 23/03/2020 |
| Date of final enrolment | 18/01/2023 |
Locations
Countries of recruitment
- Canada
Study participating centre
Corbett Hall
Room 1-43
Edmonton
T6G 2G4
Canada
Sponsor information
University/education
116 Street and 85 Avenue
Edmonton
T6G 2R3
Canada
| Phone | +1 (0)7804923113 |
|---|---|
| communications@ualberta.ca | |
| Website | https://www.ualberta.ca |
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Not defined
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Mathematics of Information Technology and Complex Systems, Mitacs Canada
- Location
- Canada
Results and Publications
| Intention to publish date | 11/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The authors plan to submit the study to the journal Disability and Rehabilitation |
| IPD sharing plan | The dataset generated during and analysed during the current study are not expected to be available due to ethics approval restrictions |
Editorial Notes
09/04/2025: Study's existence confirmed by the Health Research Ethics Board - Health Panel.
