Lateral epicondylalgia or 'tennis elbow' Musculoskeletal Diseases Lateral epicondylitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have had unilateral elbow pain at or around the lateral epicondyle of humerus for longer than six weeks 2. Elbow pain provoked by palpation on the lateral epicondyle of humerus and by gripping 3. Elbow pain triggered by either resisted wrist extension or resisted middle finger extension 4. Aged between 19 and 65 years old
Exclusion criteria
Exclusion criteria: 1. Have any other concurrent neck, shoulder, elbow, or arm disorders 2. Received injections for lateral epicondylalgia (LE) (e.g. corticosteroid, autologous whole blood, PRP, or prolotherapy) 3. Received acupuncture for LE 4. Pregnant 5. Have pacemakers or other electrical device implanted in the body 6. History of seizures or epilepsy 7. Untreated hemorrhagic disorders 8. Infected tissues, osteomyelitis, or wounds around the elbow 9. Active deep vein thrombosis or thrombophlebitis 10. Impaired sensation at and around the elbow 11. Not able to give accurate and timely feedback due to cognition or communication impairment 12. Cancerous lesions at or around the elbow 13. Who has received a radiation therapy around the elbow within the previous 6 months 14. Impaired circulation around the elbow 15. Surgery or bone fracture at or around the elbow previously 16. Needle phobia 17. Inflammatory rheumatic diseases 18. On opioid medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/04/2015: Pain-free grip strength (PFGS) will be measured with an electronic digital grip dynamometer (MIE Medical research, UK). Participants will be in supine position with the arm adducted, elbow extended, forearm pronated, and wrist extended. For measurements in affected arm, participants will be instructed to apply force gradually on the grip and stop squeezing as soon as pain is provoked; and for measurement in unaffected arm, they will be asked to squeeze the grip maximally.Measurement of affected arm with LE and unaffected arm will be taken at baseline, immediately after the treatment, 24 hours and 72 hours after the treatment. Each measurement will be repeated three times with 30 seconds interval starting with unaffected arm. ? Previous primary outcome measures: Pain-free grip strength (PFGS) will be measured with an electronic digital grip dynamometer (MIE Medical research, UK). Participants will be in supine position with the arm adducted, elbow extended, forearm pronated, and wrist extended. For measurements in affected arm, participants will be instructed to apply force gradually on the grip and stop squeezing as soon as pain is provoked; and for measurement in unaffected arm, they will be asked to squeeze the grip maximally. Measurements of affected arm with LE will be taken at baseline, immediately after an intervention, every 15 minutes for 60 minutes onward, and 24 hours after an intervention; and measurements of unaffected arm will be taken at baseline, immediately after, and 60 minutes after, and 24 hours after an intervention. Each measurement will be repeated three times with 30 seconds interval starting with unaffected arm. ? | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/04/2015: 1. Perceived pain level by participants on the numeric rating scale (NRS)?. Participants will be provided with a pain diary and be asked to rate their pain level when making a fist with maximal effort on a scale of 0 to 10. Participants will be asked to position their arm hanging on the side of their body, with their elbow extended, forearm pronated, and wrist extended, when measuring their level of elbow pain. Measurement will be taken at baseline, immediately after the treatment, then 3 times (in the morning after wake up, mid-day, bed-time) a day for 72 hours. The perceived pain level will be also measured at 1st (24 hours after the treatment) and 2nd follow-ups (72 hours later the treatment). Participants will be informed that 0 represents ‘no pain at all’ and 10 represents ‘pain as severe as it could possibly be’.? 2. Perceived level of change on the global rating of change (GROC) scale?. GROC scale is a reliable and valid measure of patient’s perceived level of change in their condition over a period of time; and it is commonly used in clinical research and practice.Participants will be asked “Over the past 24 hours since you received acupuncture treatment, how has your condition changed with respect to your elbow pain?” and be asked to rate on the 7-point Likert type scale, in which seven choices will be given (much better, moderately better, slightly better, unchanged, slightly worse, moderately worse, much worse). We will calculate success rates from the global improvement: we will consider ‘much better’ and ‘moderately better’ to be success. A survey will be implemented in order to find out: 1. Whether the blinding method is successful or not 2. Whether they had to take NSAIDS or any other painkillers for pain control during the study period 3. Whether they had to receive any therapy during the study period 4. Whether they avoided any activities that aggravate their elbow pain Previous secondary outco | — |
Countries
Canada