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Trial registered on ANZCTR


Registration number
ACTRN12609001001280
Ethics application status
Approved
Date submitted
17/11/2009
Date registered
19/11/2009
Date last updated
10/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for Chronic Knee Pain Trial
Scientific title
The effect of acupuncture on pain and physical function in patients with chronic knee pain: a randomised placebo-controlled trial.
Secondary ID [1] 280999 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic knee pain 237141 0
Condition category
Condition code
Musculoskeletal 237466 237466 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 252411 252411 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention groups, laser acupuncture and needle acupuncture. Needle acupuncture involves the use of acupuncture needles and laser acupuncture involves the aiming of laser light with a small pen-like device which is applied to the skin. The acupuncture (for both needle and laser groups) is delivered by General Practitioners who are Fellows of the College of Medical Acupuncture. There will be 8-12 treatment sessions over 12 weeks of 20 minutes per treatment. the number of treatment sessions will be determined by the treating General Practitioner (GP).
Intervention code [1] 236858 0
Treatment: Devices
Comparator / control treatment
There are two comparator groups. Sham laser acupuncture and a Zelen control group (no intervention). Half of the 280 people in the study will be invited to take part in the laser acupuncture arm of the study. People in this arm of the project will have a 50% chance of receiving real laser acupuncture and a 50% chance of receiving sham laser acupuncture, which appears like real laser acupuncture, but it does not emit a laser beam. Both real and sham treatment will be provided by the same laser acupuncture machines. Each participant will be provided with a 4-digit numeric code that can be input into the laser machines. This code will be linked to either real laser or sham laser treatment. Neither the GP nor the patient will know which form of treatment is being provided and they will not be able to tell. Hence participants in the real laser and sham laser groups will have the same number of treatment visits over 12 weeks for the same period of time.
Control group
Placebo

Outcomes
Primary outcome [1] 238271 0
The primary outcome will be pain which is obtained via numeric rating scale questionnaires
Timepoint [1] 238271 0
These will be administered at baseline, 12 weeks and 12 months.
Primary outcome [2] 253288 0
Function, which will be also measured in the WOMAC Osteoarthritis Index.
Timepoint [2] 253288 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [1] 244638 0
The Arthritis Self Efficacy questionnaire.
Timepoint [1] 244638 0
This will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [2] 262304 0
The Illness Perception Questionnaire Revised
Timepoint [2] 262304 0
This will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [3] 262305 0
Quality of Life, measured by The 12-Item Short Form Health Survey (SF-12), the Assessment of Quality of Life (AQOL) and the Revised Health Hardiness questionnaire.
Timepoint [3] 262305 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [4] 262306 0
Physical activity levels as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire.
Timepoint [4] 262306 0
This will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [5] 262307 0
Psychosocial health as measured by the Medical Outcomes Study (MOS) Social Support Survey and the 9-item Patient Health Questionnaire (PHQ-9)
Timepoint [5] 262307 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [6] 262308 0
Health economics, as measured by a recall questionnaire of all use of health professionals, medical tests, medications and absence from work in the previous 4 weeks.
Timepoint [6] 262308 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [7] 298717 0
Global change scale. Patients are asked to rate change in pain, physical function and overall from either much worse, slightly worse, no change, slightly better or much better.
Timepoint [7] 298717 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [8] 298718 0
Numeric rating scale of pain on walking and standing
Timepoint [8] 298718 0
These will be administered at baseline, 12 weeks and 12 months.
Secondary outcome [9] 298719 0
Pain subscale of the Western Ontario and McMaster Universities (WOMAC) index
Timepoint [9] 298719 0
Baseline, 12 weeks and 12 months

Eligibility
Key inclusion criteria
Inclusion criteria will be community-based patients over the age of 50 years with pain, stiffness or both in one or both knees and able to give written, informed consent.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be serious knee joint pathology (e.g. inflammatory arthritis, acute trauma, history of intra-articular fracture or malignancy), compensable knee injury, previous knee joint replacement, being on the waiting list for knee surgery, use of acupuncture within the past 12 months, needle phobia, bleeding diatheses or use of oral anticoagulant medication, knee pain arising from other structures (e.g. hip or spine), neurological disease affecting the lower limbs, having a separate injury that may influence the perception of pain, have been referred to a pain clinic or have evidence of neuropathic pain syndrome.

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)
A standard single consent Zelen methodology will be used whereby participants are initially enrolled into a longitudinal study. Following enrolment into the study, participants will be covertly randomised into one of four groups: (1) a no treatment control group, (2) laser acupuncture, (3) sham laser acupuncture and (4) needle acupuncture.

The allocation will be concealed and will be done using a computer program controlled by an administrator of the randomization sequencing, not involved in screening, recruitment or data management.

The participants in the no treatment control group are not informed about the other treatment groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation which will be done with the use of a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237543 0
Government body
Name [1] 237543 0
National Health and Medical Research Council (NHMRC)
Country [1] 237543 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, School of Physiotherapy
Address
200 Berkeley St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 251387 0
None
Name [1] 251387 0
Address [1] 251387 0
Country [1] 251387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243681 0
University of Melbourne Ethics Committee
Ethics committee address [1] 243681 0
Ethics committee country [1] 243681 0
Australia
Date submitted for ethics approval [1] 243681 0
Approval date [1] 243681 0
01/08/2009
Ethics approval number [1] 243681 0
0931840.1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29835 0
Address 29835 0
Country 29835 0
Phone 29835 0
Fax 29835 0
Email 29835 0
Contact person for public queries
Name 13082 0
Ben Metcalf
Address 13082 0
School of Physiotherapy
The University of Melbourne VIC 3010
Country 13082 0
Australia
Phone 13082 0
+61 3 8344 8127
Fax 13082 0
Email 13082 0
b.metcalf@unimelb.edu.au
Contact person for scientific queries
Name 4010 0
Ben Metcalf
Address 4010 0
School of Physiotherapy
The University of Melbourne VIC 3010
Country 4010 0
Australia
Phone 4010 0
+61 3 8344 8127
Fax 4010 0
Email 4010 0
b.metcalf@unimelb.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.