The time course of pain relief provided by acupuncture in treatment of tennis elbow

• Register: ISRCTN
• Last refreshed on: 4 September 2017
• Main ID: ISRCTN14667535
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: The time course of pain relief provided by acupuncture in treatment of tennis elbow
• Scientific title: The time course of the analgesic effect of acupuncture in treatment of lateral epicondylalgia (LE): a pilot study?
• Date of first enrolment: 01/05/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14667535
• Study type: Interventional
• Study design: Interventional single-center study (Treatment)

Countries of recruitment

Canada

Contacts

• Name: Jaewon Jeon

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Lateral epicondylalgia or 'tennis elbow'
Musculoskeletal Diseases
Lateral epicondylitis

Intervention(s)

Participants will be randomly assigned to receive one of two types of acupuncture treatment: electroacupuncture (EA) or standard acupuncture. A randomization list of 40 equally weighted allocations will be generated in REDCAP prior to the start of the study. The third person who is not involved in this study protocol will press a randomization button in REDCAP to produce the allocation code for each participant, after confirming the placement of needles by the clinician.

In both groups, participants will receive acupuncture on LI 4, SJ 5, LU 5, LI 10, LI 12, SP 6, and GB 34. Only sterile, single-use, disposable stainless steel needles will be used (Serin J-type, 40mm x 0.25mm) for both treatment groups. After inserting acupuncture needles into the skin to required depth (1.5- 3.5 cm), the clinician will manipulate acupuncture needles until patients feel deqi (arrival of qi). Deqi is a subjective feeling of a patient at the region where an acupuncture needle is inserted into the acupoint and it is characterized by aching, soreness, numbness, tingling, pressure, or heaviness. Acupuncture needles will be retained in the body for 30 minutes. The only difference between two groups will be that, in EA group, participants will receive electro- stimulation between two pairs of acupoints: one pair between LI 10 and LI 12 and the other pair between LI 4 and SJ 5. Electro-stimulation will be applied using electro- acupuncture unit (ES-160) (ITO Physiotherapy and rehabilitation, Japan) which has met the health and safety requirement set by European standard (CE marking) and is widely used in Canadian clinics (distributor ELECTRO-THERAPEUTIC DEVICES INC). Frequency will be set as alternating between 10 and 30Hz (alternating between two frequencies every 3 seconds) and the delivery mode will be set as fast and slow. The pulse width will be set as 400 microseconds. Intensity will be set and maintained at a point at which participants get sensory stimulus, such as tingling or num

Primary Outcome(s)

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 Outcome(s)

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 outcome measures:
1. Pressure pain threshold (PPT). Participants will be in supine position with elbow extended and forearm pronated. PPT will be measured at a tender point of the lateral epicondyle of the humerus using a probe of the computerized pressure algometer (Algomed, Medoc Advanced Medical systems, US) at a pressure rate of 40kPa/sec. Participants will be given a patient response unit and be asked to press the button as soon as they feel the onset of pain. PPT will be repeatedly measured until three sequential PPT measurements have a discrepancy of less than 10%. When PPT value stabilizes, PPT at baseline will be recorded. PPT of affected arm will be measured at baseline, immediately after an intervention, and every 15 minutes for 60 minutes onward, and 24 hours after an intervention. PPT of unaffected arm will be measured 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. ?
2. 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 an intervention, every 15 minutes for 60 minutes onward, then every 4 hours for 72 hours except during sleep hours. Participants will be informed that 0 represents ‘no pain at all’ and 10 represents ‘pain as severe as it could possibly be’.?
3. 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 5-point Likert type scale, in which five choices will be given such as, much better, slightly better, unchanged, slightly worse, and much worse. We will calculate success rates from the global improvement: we will consider ‘much better’ to be success.

Secondary ID(s)

H15-00439

Source(s) of Monetary Support

Investigator initiated and funded