Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000944538
Ethics application status
Approved
Date submitted
26/08/2015
Date registered
9/09/2015
Date last updated
8/04/2019
Date data sharing statement initially provided
8/04/2019
Date results information initially provided
8/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for knee osteoarthritis and chronic low back pain
Scientific title
Acupuncture analgesia:its relationship with pain adaptability and endogenous pain control in chronic low back pain and knee osteoarthritis patients
Secondary ID [1] 286142 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain 294152 0
knee osteoarthritis 296119 0
Condition category
Condition code
Alternative and Complementary Medicine 294474 294474 0 0
Other alternative and complementary medicine
Musculoskeletal 294475 294475 0 0
Osteoarthritis
Musculoskeletal 296382 296382 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will receive eight sessions of acupuncture twice a week over four weeks. A registered and experienced acupuncturist will deliver the acupuncture. At each session, participants will receive manual acupuncture for a duration of 20-30 minutes at tender points at or close to the site of pain condition. Four to eight points are needled. A record of each acupuncture session is kept. To monitor compliance and adherence participants are sent reminders for the acupuncture appointments. We also offer a flexible schedule to accommodate the participants who cannot come within working hours. The participants in this study were also part of a psychophysics research project determining their pain adaptability through a cold pressor test (the psychophysics research project is not a clinical trial so it does not have a registration number). At the end of the acupuncture treatment participants will undergo psychophysics tests. Please see information about secondary outcome measures.
Intervention code [1] 292685 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295941 0
Intensity of knee pain or low back pain assessed with a paper-based pain diary
Timepoint [1] 295941 0
At one week before the 1st acupuncture treatment and one week after the last acupuncture treatment
Secondary outcome [1] 316982 0
Functional status measured using the modified Roland Morris Quesionnaire
Timepoint [1] 316982 0
before the 1st and after the last acupuncture treatment
Secondary outcome [2] 316983 0
Quality of life measured using SF-36
Timepoint [2] 316983 0
Before the 1st and after the last acupuncture session
Secondary outcome [3] 316984 0
Psychophysics characteristics measured using validated quantitative sensory tests: pressure pain threshold, thermal sensory thresholds and cold pressor test
Timepoint [3] 316984 0
Before the 1st and after the last acupuncture session

Eligibility
Key inclusion criteria
1. Chronic non-specific low back pain sufferers, meeting the following criteria:

- aged 20-65years

- Diagnosed with chronic non-specific low back pain by a general health practitioner or a registered health practitioner (eg: chiropractor, physiotherapist, osteopath) OR meeting the recommendations from the American College of Physicians and the American Pain Society (R. Chou et la, 'Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of physicians and the American Pain Society', Ann Intern Med, 147(2007),478-91)

- experienced ongoing pain at or above two out of 10 on a 10cm visual analogue scale (VAS) in the previous week

-adequate conversational English

OR

2. knee osteoarthritis sufferers meeting the following criteria:

- aged 40-80 years

- diagnosed with osteoarthritis (by a general practitioner or a registered health care practitioner) in one/ both knees for more than six months OR knee pain with at least three out of six of the following criteria as recommended by the American College of Rheumatology (R. Altman et al, The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the knee, Arthritis Rhuem 1986;29:1039-1049):
1. Age more that 50 years
2. stiffness for more than 30 minutes
3. crepitus
4. bony tenderness
5. bony enlargement
6. no palpable warmth

- Experienced ongoing pain at or above two out of 10 on a 10cm visual analogue scale (VAS) in the previous week

- adequate conversational English
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. For chronic non-specific low back pain suffers:

- Regular anti-convulsant, anti-depressant or opioid use for pain.

- People with Chronic non-specific low back pain who also have knee osteoarthritis

-Radicular pain, osteosporosis, surgery or previous fractures of the spine, history of acute trauma in the spine, low back pain caused by inflammatory, malignant, or autoimmune disease (or other low back pain from specific reasons)

-Pregnancy or intent to become pregnant, breast feeding, brain tumor, cancer, hemophilia or peripheral neuropathy.

-Frequent recreational drug or excessive alcohol use.

- Uncontrolled hypertension

-Injuries in areas to be tested

2. For knee osteoarthritis sufferers:

-Regular anti-convulsant, anti-depressant or opioid use for pain.

-People with knee OA osteoarthritis who also have Chronic non-specific low back pain

-Pregnancy or intent to become pregnant, breast feeding, brain tumor, cancer, hemophilia or peripheral neuropathy.

- Frequent recreational drug or excessive alcohol use.

- Uncontrolled hypertension

- Injuries in areas to be tested

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
The participants and the acupuncturist are blinded from the participants' pain adaptability. The outcome assessor is blinded from the daily level of pain of the participants (pain diary).
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
We anticipate to recruit 90 participants with chronic non-specific low back pain participants or knee osteoarthritis. This is a pilot study; we will use the results to calculate the sample size for future studies. Commonly it is accepted that psychophysics studies have 20-40 people per group.

The Statistical Program for Social Science (SPSS, version 22.0) and Labchart8 will be used for data analyses. Categorical and numerical data of baseline pain and, demographic characteristics such as gender and age will be analysed with chi square test and t-tests, respectively, to determine comparability of the groups. Missing data will be dealt with using the last value carried forward method or according to individual manual of questionnaires. Two-way ANOVA (Group: pain adaptive and pain non-adaptive; time) will be used to examine the treatment effect and the interaction of pain adaptability and time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/05/2015
Actual
18/05/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
29/02/2016
Date of last data collection
Anticipated
Actual
4/04/2016
Sample size
Target
90
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10212 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 291911 0
University
Name [1] 291911 0
RMIT university
Country [1] 291911 0
Australia
Primary sponsor type
University
Name
RMIT university
Address
PO BOX 71, Bundoora, Vic 3083
Country
Australia
Secondary sponsor category [1] 290580 0
None
Name [1] 290580 0
Address [1] 290580 0
Country [1] 290580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293418 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 293418 0
RMIT University
City Campus 91.2.12
GPO Box 2476,
Melbourne
Victoria 3001
Ethics committee country [1] 293418 0
Australia
Date submitted for ethics approval [1] 293418 0
02/09/2014
Approval date [1] 293418 0
15/01/2015
Ethics approval number [1] 293418 0
48/14

Summary
Brief summary
Chronic non-specific low back pain and knee osteoarthritis are among the most prevailing chronic pain conditions. Despite the a wide array of treatment options available, not everyone receives satisfactory pain relief. This may be because people respond differently to pain treatments. An optimal and safe treatment is necessary.
This project aims to determine whether people with two forms of pain adaptability respond differently to local acupuncture needling. We test this aim in people with knee osteoarthritis or low back pain. The pain adaptability of the participants has previously been determined using a cold pressor test. The acupuncturist is blinded from participants’ pain adaptability and delivers an acupuncture treatment of 8 sessions. The response to acupuncture is measured by assessing the change in pain at the knee or lower back through a pain diary before and after the acupuncture treatment. This project will contribute to the development of individualised medicine by targeting those who respond better to acupuncture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54806 0
Dr Zhen Zheng
Address 54806 0
Dr Zhen Zheng
Discipline of Chinese Medicine, RMIT University
PO BOX 71, Bundoora, Vic 3083
Country 54806 0
Australia
Phone 54806 0
+61 3 9925 7167
Fax 54806 0
Email 54806 0
[email protected]
Contact person for public queries
Name 54807 0
Dr Zhen Zheng
Address 54807 0
Dr Zhen Zheng
Discipline of Chinese Medicine, RMIT University
PO BOX 71, Bundoora, Vic 3083
Country 54807 0
Australia
Phone 54807 0
+61 3 9925 7167
Fax 54807 0
Email 54807 0
[email protected]
Contact person for scientific queries
Name 54808 0
Dr Zhen Zheng
Address 54808 0
Dr Zhen Zheng
Discipline of Chinese Medicine, RMIT University
PO BOX 71, Bundoora, Vic 3083
Country 54808 0
Australia
Phone 54808 0
+61 3 9925 7167
Fax 54808 0
Email 54808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.