The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000676213
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
7/08/2009
Date last updated
15/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of electroacupuncture on opioid consumption by patients with chronic pain
Scientific title
Effect of electroacupuncture on opioid consumption by patients with chronic musculoskeletal pain: a randomised sham acupuncture controlled trial
Secondary ID [1] 279927 0
NIL
Universal Trial Number (UTN)
Trial acronym
EA OM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic musculoskeletal pain 236907 0
use of opioid medications 236908 0
Condition category
Condition code
Musculoskeletal 237261 237261 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 237262 237262 0 0
Other alternative and complementary medicine
Other 237491 237491 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electrical acupuncture will be applied to the arms and legs. During the treatment, electrical current delivered with a battery-operated eletrical stimulator is combined with acupuncture needle techniques to enhance stimulation of the acupuncture points. Each treatment session takes 25 to 30 minutes. The treatment will be given twice a week for four weeks followed by once a week for two weeks then once every two weeks for four weeks. In total, 12 sessions are delivered within 10 weeks.

Participants in this group will also receive pain and medication management (i.e., standard care).
Intervention code [1] 236696 0
Treatment: Devices
Comparator / control treatment
Conotrol arm 1: Sham electroacupuncture control.
This group will receive similar treatment to that delivered to the real electroacupuncture group. Each session takes 25 to 30 minutes. In total, 12 sessions of treatment are delivered within 10 weeks.

Participants in this group will also receive pain and medication management (i.e., standard care).

Control arm 2: Standard care control (pain and medication management)
This group will receive pain and medication management for 10 weeks without electroacupuncture treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 238078 0
The weekly dosage of opioid medicaitons (OM). This will be calculated based on the data recorded by the pariticipants in their Pain and Medication Diary.
Timepoint [1] 238078 0
At the end of the treatment period, i.e. 10 weeks following randomisation.
Secondary outcome [1] 242269 0
1) Number of participants who achieve 50% OM reduction
Timepoint [1] 242269 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [2] 242270 0
2) Type, severity and incidence of OM related common adverse events (AEs). Common AEs are somnolence, mental clouding, nausea and constipation. They are assessed with six-point scales (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extremely severe) to indicate the severity of these events. The scales are included at the end of Pain and Medication Diary that is completed by the participants.
Timepoint [2] 242270 0
at the end of the treatment period, i.e. 10 weeks following randomisation
Secondary outcome [3] 242271 0
3) Pain intensity measured with Visual Analogue Scales (VASs; 0 = no pain; 10 = worst pain possible) and with the numerical scales included in the Brief Pain Inventory
Timepoint [3] 242271 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [4] 244686 0
4) Consumption of non-opioid medications that are recorded by the participants in their Pain and Medication Diary. To make meaningful comparisons of non-opioid medications use, the dosage of such medications will be calculated according to Medication Quantification Scale Version III (MQS).
Timepoint [4] 244686 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [5] 244687 0
5) Quality of life assessed with SF-36v2 Health Survey
Timepoint [5] 244687 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [6] 244688 0
6) participants' attitude of paina as assessed with Survey of Patients Attitude.
Timepoint [6] 244688 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [7] 257052 0
7) The level of function assessed with the Roland-Morris Disability Questionnaire (RMDQ) and the Brief Pain Inventory;
Timepoint [7] 257052 0
At the end of the treatment period, i.e. 10 weeks following randomisation; and
at the end of the follow-up period, i.e. three months after the end of the treatment.
Secondary outcome [8] 257053 0
8) The presentation and severity of withdrawal symptoms assessed with Short Opiate Withdrawal Scale.
Timepoint [8] 257053 0
At the end of the treatment period, i.e. 10 weeks following randomisation
Secondary outcome [9] 257054 0
10) The proportion of neuropathic versus nociceptive pain assessed with the Self-administered Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
Timepoint [9] 257054 0
At the end of the treatment period, i.e. 10 weeks following randomisation
Secondary outcome [10] 257055 0
11) The Perception of EA Treatment Questionnaire will be given to the two electroacupuncture groups to assess the success of blinding
Timepoint [10] 257055 0
In the 6th and 14th weeks, i.e. two and 10 weeks following randomisation.

Eligibility
Key inclusion criteria
1) age between 18 and 85 years at entry; 2) confident in conversational and reading English; 3) suffering from chronic musculoskeletal pain (CMP), regardless of the locations of pain; and 4) have taken opioid medication (OM) regularly for more than two months without dose limitation.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) active abuse of OM as judged by a medical doctor (MD); 2) severely depressed with suicidal tendency as judged by MDs; 3) unstable heart condition, pregnancy or intent to become pregnant, breast feeding women, epilepsy, brain tumor, current cancer, hemophilia or wearing cardiac pacemakers; 4) no general practitioner available for liaison; 5) acupuncture treatment in the last 12 months; or 6) unwilling to reduce OM.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential subjects will be recruited from two pain management centres in Melbourne. After a four-week run-in period, subjects who meet all selection criteria will be randomly allocated into one of the three groups, namely real electroacupuncture, sham electroacupuncture or no electroacupuncture with a 2:1:1 ratio. Central randomisation by phone will be used. The acupuncturist is the only person who will know the treatment allocation. All other clinicians and reseachers will be blinded to the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated telephone randomisation service will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All subjects will receive pain and medication management from the medical doctors at the clinics.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1879 0
3052
Recruitment postcode(s) [2] 1789 0
3162

Funding & Sponsors
Funding source category [1] 237086 0
Government body
Name [1] 237086 0
National Health & Medical Research Council(NHMRC)
Address [1] 237086 0
GPO Box 1421
Canberra, ACT 2601
Country [1] 237086 0
Australia
Primary sponsor type
Individual
Name
Professor Charlie Xue
Address
Discipline of Chinese Medicine,
School of Health Sciences,
PO Box 71, Bundoora, Vic 3083
Country
Australia
Secondary sponsor category [1] 236754 0
Individual
Name [1] 236754 0
Doctor Zhen Zheng
Address [1] 236754 0
Discipline of Chinese Medicine,
School of Health Sciences.
PO Box 71, Bundoora, Vic 3083
Country [1] 236754 0
Australia
Secondary sponsor category [2] 236755 0
Individual
Name [2] 236755 0
Professor Stephen Gibson
Address [2] 236755 0
National Ageing Research Institute,
Poplar Road,
PO Box 2127,
Parkville, Vic 3050
Country [2] 236755 0
Australia
Secondary sponsor category [3] 236756 0
Individual
Name [3] 236756 0
Professor Robert Helme
Address [3] 236756 0
Department of Medicine,
Royal Melbourne Hospital,
Parkville, Vic 3050
Country [3] 236756 0
Australia
Secondary sponsor category [4] 236757 0
Individual
Name [4] 236757 0
Doctor Carolyn Arnold
Address [4] 236757 0
Caulfield Pain Management and Research Centre,
Caulfield Hospital,
260 Kooyong Rd, Caulfield, Vic 3162
Country [4] 236757 0
Australia
Secondary sponsor category [5] 236758 0
Individual
Name [5] 236758 0
Doctor Malcolm Hogg
Address [5] 236758 0
Pain Services,
Royal Melbourne Hospital,
Poplar Road, Royal Park Campus,
Parkville, Vic 3050
Country [5] 236758 0
Australia
Other collaborator category [1] 703 0
Hospital
Name [1] 703 0
Caulfield Pain Management and Research Centre
Address [1] 703 0
Caulfield Hospital,
260 Kooyong Rd, Caulfield, Vic 3162
Country [1] 703 0
Australia
Other collaborator category [2] 746 0
Hospital
Name [2] 746 0
Pain Services
Address [2] 746 0
Royal Melbourne Hospital,
Poplar Road, Royal Park Campus,
Parkville, Vic 3050
Country [2] 746 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239188 0
The Alfred Research & Ethics Unit
Ethics committee address [1] 239188 0
The Alfred Health,
55 Commercial Road, Melbourne, Vic 3004
Ethics committee country [1] 239188 0
Australia
Date submitted for ethics approval [1] 239188 0
16/03/2009
Approval date [1] 239188 0
02/06/2009
Ethics approval number [1] 239188 0
HREC 80/09
Ethics committee name [2] 239189 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 239189 0
Office for Research,
Level 6 East, Main Building,
Grattan Street,
The Royal Melbourne Hospital, Parkville, Vic 3050
Ethics committee country [2] 239189 0
Australia
Date submitted for ethics approval [2] 239189 0
25/02/2009
Approval date [2] 239189 0
17/06/2009
Ethics approval number [2] 239189 0
2009.033
Ethics committee name [3] 239369 0
Royal Melbourne Institute of Technology (RMIT) University Human Research Ethics Committee
Ethics committee address [3] 239369 0
Research & Innovation, RMIT,
GPO Box 2476V,
Melbourne, Vic 3001
Ethics committee country [3] 239369 0
Australia
Date submitted for ethics approval [3] 239369 0
16/02/2009
Approval date [3] 239369 0
20/04/2009
Ethics approval number [3] 239369 0
06/09/

Summary
Brief summary
Our primary hypothesis is that electroacupuncture (EA), as a supplementary therapy to stardard care, that is pain medication management (PMM), can effectively reduce the use of opioid medications (OMs) in the management of chronic musculoskeletal pain (CMP).

About the problem: Seventeen (17%) to 20% of Australians suffer from chronic pain, with the majority of them having CMP. Moderate to severe CMP has been increasingly managed with OM. In Australia, in 1999, 13% of chronic pain patients were using some type of OMs. Since then, the consumption of some OMs has increased by 5 to 40 times.
About the use of OMs: Although short-term benefit of OMs for CMP has been demonstrated, its long-term use is a problem. Studies have shown that chronic pain patients who are on long-term OMs, experience more severe pain, poorer quality of life, and are more likely to have adopted passive pain coping strategies. Thus, effective measures that reduce the OM use and OM related adverse effects are urgently needed.
About EA and its benefit: Animal and human studies have shown that EA not only increases the release of endogenous opioids, but also help our body to use opioid medications more efficiently. Our pilot study (Zheng et al, EJP, 2008) demonstrated that real EA, when combined with PMM, reduced the OM consumption more effectively than sham EA did. The proposed research will employ an adequate sample size with an additional no-EA group to determine the benefit and safety of EA for the reduction of OM consumption by subjects with CMP.
Trial website
Trial related presentations / publications
Zheng, Z., Guo, R. X., Helme, R. D., Muir, A., Da Costa, C. and Xue, C. L. (2008) The effect of electroacupuncture on opioid-like medication consumption by chronic pain patients: A randomized controlled clinical trial. European Journal of Pain 12(5):671-6.
Public notes

Contacts
Principal investigator
Name 29687 0
Address 29687 0
Country 29687 0
Phone 29687 0
Fax 29687 0
Email 29687 0
Contact person for public queries
Name 12934 0
Prof Charlie Xue
Address 12934 0
Discipline of Chinese Medicine,
School of Health Sciences,
PO Box 71, Bundoora,
Vic 3083
Country 12934 0
Australia
Phone 12934 0
+61 3 9925 7745
Fax 12934 0
+61 3 9925 7178
Email 12934 0
charlie.xue@rmit.edu.au
Contact person for scientific queries
Name 3862 0
Doctor Zhen Zheng
Address 3862 0
Discipline of Chinese Medicine,
School of Health Sciences,
PO Box 71, Bundoora,
Vic 3083
Country 3862 0
Australia
Phone 3862 0
+61 3 9925 7167
Fax 3862 0
+61 3 9925 7178
Email 3862 0
zhen.zheng@rmit.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary