Condition category
Neonatal Diseases
Date applied
03/02/2016
Date assigned
05/02/2016
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Not Specified

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

https://www.cgmh.org.tw/eng2002/intr_hel.htm

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27143983

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.