Does manipulation therapy relieve pain more rapidly than acupuncture among lateral epicondylalgia?

ISRCTN ISRCTN81308551
DOI https://doi.org/10.1186/ISRCTN81308551
Secondary identifying numbers N/A
Submission date
03/02/2016
Registration date
05/02/2016
Last edited
10/08/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Hsin-Chia Huang
Scientific

No.123, Dinghu Rd
Guishan Township
Taoyuan City
333
Taiwan

ORCiD logoORCID ID 0000-0002-1338-079X

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleComparison of manipulation treatment with acupuncture treatment in pain relief among lateral epicondylalgia
Study objectivesWe hypothesized that pathological tension in the biceps brachii muscle is related to lateral epicondylalgia.
Ethics approval(s)Chang-Gung Memorial Foundation, Taipei, Taiwan, ref: IRB No.: 99-1544A3
Health condition(s) or problem(s) studiedLateral epicondylalgia
InterventionParticipants 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 typeOther
Primary outcome measurePain, 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 measures1. 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 study start date22/06/2010
Completion date30/10/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants35
Key inclusion criteria1. 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
Key exclusion criteriaPatients 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
Date of first enrolment03/03/2011
Date of final enrolment07/09/2012

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Chang Gung Memorial Hospital
333
Taiwan

Sponsor information

Chang Gung Memorial Hospital (R.O.C)
Hospital/treatment centre

No.123, Dinghu Rd
Guishan Township
TAOYUAN
333
Taiwan

Website https://www.cgmh.org.tw/eng2002/intr_hel.htm
ROR logo "ROR" https://ror.org/02verss31

Funders

Funder type

Hospital/treatment centre

Chang Gung Memorial Hospital, Linkou
Private sector organisation / Other non-profit organizations
Alternative name(s)
Linkou Chang Gung Memorial Hospital
Location
Taiwan

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWe would like to publish our result on the “Orthopedic”, “Rehabilitation” or “Complementary and Alternative Medicine” field in early 2016.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2016 Yes No

Editorial Notes

10/08/2017: Internal review.
05/05/2016: Publication reference added.