Plain English Summary
Background and study aims
Tennis elbow (lateral epicondylalgia) is a condition that results in pain around the outside of the elbow. Sufferers may experience this pain when they bend or lift their arm, when they grip smaller objects (such as a pen) or when twisting the forearm to – for example – turn a doorknob or open a jar. It is caused by overusing the muscles of the elbow. Tennis elbow will eventually get better on its own without treatment, but, for some 20% of cases, symptoms may continue for a year or more. Treatment for the condition often involves a combination of non-pharmacological (drug) therapies. These include corticosteroid injection, iontophoresis, botulinum toxin A, prolotherapy, platelet-rich plasma or autologous blood injection, bracing, physical therapy, shockwave therapy, and laser therapy; however, the results of these treatments remain inconclusive. Manipulation treatment and acupuncture are usually used to lateral epicondulalgia treatment in Traditional Chinese Medicine but there has been little research into comparing how well they perform. This study investigates whether manipulation treatment is beneficial and provides more satisfactory results when compared with acupuncture treatment in patients with lateral epicondylalgia.
Who can participate?
Patients suffering from tennis elbow for longer than 2 months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive manipulation treatment twice a week for two weeks. Those in group 2 receive acupuncture treatment twice a week for two weeks. All participants are assessed in terms of how much pain they experience, how hard they can grip and how well their arm is functioning at various periods throughout the study and for up to eight weeks after treatment.
What are the possible benefits and risks of participating?
Possible risks include light hemorrhage or hematoma for participants in the acupuncture group and some pain (during treatment) for those participants in the manipulation group.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
March 2011 to September 2012
Who is funding the study?
Chang Gung Memorial Hospital (Taiwan)
Who is the main contact?
Dr Hsin-Chia Huang
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hsin-Chia Huang
ORCID ID
http://orcid.org/0000-0002-1338-079X
Contact details
No.123
Dinghu Rd
Guishan Township
Taoyuan City
333
Taiwan
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of manipulation treatment with acupuncture treatment in pain relief among lateral epicondylalgia
Acronym
Study hypothesis
We hypothesized that pathological tension in the biceps brachii muscle is related to lateral epicondylalgia.
Ethics approval
Chang-Gung Memorial Foundation, Taipei, Taiwan, ref: IRB No.: 99-1544A3
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Lateral epicondylalgia
Intervention
Participants were randomly allocated to one of two groups:
1. Manipulation group: participants received radial bone adjustment by being rotated internally the radial bone and extended the biceps brachii muscle simultaneously. The physician performed the manipulation procedure twice in 1 minute with an interval of 30 seconds.
2. Acupuncture group: participants received six acupoints on the forearm, according to a study in Rheumatology published by the Hannover Medical School, Germany. The needle was inserted into the muscle layer and twisted until the de qi sensation was felt. The needle remained in situ for 25 minutes.
Both the manipulation and acupuncture groups received the treatments twice per week for 2 weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Pain, measured using the pain visual analog scale score (VAS), before treatment in three states, rest, daily activity, and work situations, from the beginning of the study up to 8 weeks following.
Secondary outcome measures
1. Functional impairment, measured by the Disability of Arm, Shoulder, and Hand (DASH) questionnaire, measured at the beginning of treatment as a baseline, the end of treatment, and followed for 2 and 8 weeks after the end of treatment
2. Grip strength (pain- free and maximum), measured using the Jamar hand dynamometer, before treatment in three states, rest, daily activity, and work situations, from the beginning of the study up to 8 weeks following
Overall trial start date
22/06/2010
Overall trial end date
30/10/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Elbow pain for >2 months
2. Unilateral elbow pain
3. No improvement in the condition despite receiving treatment in previous 4 weeks
4. Visual analog scale(VAS) score> 30
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35
Participant exclusion criteria
Patients who had:
1. Central or peripheral nervous system diseases
2. Radial nerve entrapment
3. Inflammatory rheumatic disease
4. Gout
5. Radiocapitellar osteoarthritis
6. Undergone a operation for tennis elbow
7. Become pregnant
Recruitment start date
03/03/2011
Recruitment end date
07/09/2012
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital
333
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital (R.O.C)
Sponsor details
No.123
Dinghu Rd
Guishan Township
TAOYUAN
333
Taiwan
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Memorial Hospital, Linkou
Alternative name(s)
Linkou Chang Gung Memorial Hospital
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Taiwan
Results and Publications
Publication and dissemination plan
We would like to publish our result on the “Orthopedic”, “Rehabilitation” or “Complementary and Alternative Medicine” field in early 2016.
Intention to publish date
30/06/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27143983