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Trial registered on ANZCTR


Registration number
ACTRN12619000614190
Ethics application status
Approved
Date submitted
31/01/2019
Date registered
24/04/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Detecting the change of acupuncture points in patients with chronic low back pain
Scientific title
Detection of sensitization phenomena at disease-related acupoints in patients with chronic low back pain: Protocol for a matched case-control study
Secondary ID [1] 297231 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 311295 0
Condition category
Condition code
Alternative and Complementary Medicine 309920 309920 0 0
Other alternative and complementary medicine
Musculoskeletal 309922 309922 0 0
Other muscular and skeletal disorders
Neurological 310014 310014 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a matched case-control study aimed to observe the sensitization phenomena at disease-related acupoints in patients with chronic low back pain. 16 patients with chronic low back pain and 16 healthy participants with matched age, sex and ethnicity will be recruited. Algometer, infrared camera, skin conductance detector will be used to test the pressure pain threshold, local temperature, and skin conductance (respectively) on acupoints of interest in these two groups. Abnormality of local tissue and skin will be detected by inspection and palpation, and the distance from the most painful site to the standard acupoint location will be measured to determine if there is enlargement of receptive field or acupoint location switch under the influence of the low back pain. Correlation between severity of low back pain and pressure pain threshold will be used to explore the general law of acupoint sensitization.

This will be a one-time assessment, the duration of observation is around 60 mins.

All measurements will be conducted by the same practitioner, to ensure consistency in approach. The practitioner is required to be a registered acupuncturist in New Zealand (H.T.), with at least 4 years training, and has clinical experience of more than 2 years.
Intervention code [1] 313510 0
Not applicable
Comparator / control treatment
This is a case-control study, healthy candidates will be enrolled in control group, compared to patients with chronic low back pain.
Control group
Active

Outcomes
Primary outcome [1] 318875 0
The primary outcome is pressure pain threshold (PPT), PPT is defined as the minimal intensity of stimulus to induce initial pain that can be perceived by a person.
AlgoMed (Medoc Ltd., Ramat Yishai, Israel) will be used to quantitatively detect the pressure pain threshold (PPT) on low back pain related acupoints (Bilateral BL 23, BL 25, BL40) and 2 points that are 2cm lateral to BL 25.
Timepoint [1] 318875 0
immediate assessment
Secondary outcome [1] 366298 0
Presence of tissue abnormality: the number and percentage of participants who report tissue abnormality in each group will be compared,
Local tissue abnormality will be observed: the change of skin color, skin integrity (desquamation, damage, wound), and skin texture (hardness, glossiness, humidity, roughness); pathological tissues like nodule, streak, papula, dimpling will be recorded.
Timepoint [1] 366298 0
immediate assessment
Secondary outcome [2] 366299 0
Deviation distance between the center of standard acupoint location and sensitized point: will be assessed by tape.
Timepoint [2] 366299 0
immediate assessment
Secondary outcome [3] 366300 0
Presence of pain sensitized acupoints: the number and percentage of pain sensitized acupoints that figured out by comparing the PPT between 2 groups.
Timepoint [3] 366300 0
immediate assessment
Secondary outcome [4] 366301 0
Local temperature at acupoints: MobIR® M8 Thermal Camera (Wuhan Guide Infrared Co., Ltd., China; See Figure 3) will be used for thermography.
Timepoint [4] 366301 0
immediate assessment
Secondary outcome [5] 366302 0
Skin conductance at acupoints: Diode laser THOR LX2 ® (Thor Photomedicine Ltd, Chesam, UK; See Figure 4) will be used to detect skin conduction.
Timepoint [5] 366302 0
immediate assessment

Eligibility
Key inclusion criteria
A change has been made on criteria for healthy controls:
We change "No history of back pain or back related health issue" to "Don't have back pain or back related health issue in the previous 12 months"

The complete content in update field should be:
1. Patients with chronic low back pain
-Meet the diagnostic criteria of low back pain in NICE clinical guideline (No.59);
-not less than 18 years old;
-Pain duration more than 3 months (either intermittent or consecutive pain);
-Signed informed consent.

2. Healthy controls
-Healthy controls will be matched to patients with low back pain in terms of sex, ethnicity, and age within the range of 5 years;
-Good general health;
-Don't have back pain or back related health issue in the previous 12 months;
-Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patients with chronic low back pain
-Serious spinal disorders including malignancy, vertebral fracture, spinal infection, spinal stenosis, inflammatory spondylitis, cauda equine syndrome;
-History of spinal surgery;
-Take medications like acetaminophen, duloxetine, benzodiazepines, opioids, corticosteroids, anticonvulsants, NSAIDs in the prior 1 week;
-Received acupuncture for low back pain in the latest 4 weeks;
-Accompanying serious respiratory, circulatory, endocrine, urinary, or digestive system disease, etc;
-Mental ill health, such as dementia, schizophrenia, addictive behaviors; or severe depression (PHQ-9 score more than or equal to 15), severe anxiety (PASS score more than 38).
-Unable to communicate in English;
-Severe disability (RDQ more than or equal to 20), flu, fibromyalgia, rheumatoid arthritis, sacroiliac joint pain or injury.
-Are pregnancy or lactation period;
-Have skin damage or open wound on the lower back;


2. Healthy controls
-As the points of interest are all on bladder meridian, health problems related to bladder meridian will be excluded;
-BL 23 and BL 25 are the Back-shu points of kidney and large intestine respectively, so the diseases related to these 2 organs will be excluded;
-Taking medications like acetaminophen, duloxetine, benzodiazepines, opioids, corticosteroids, anticonvulsants, NSAIDs in the prior 1 week for any reasons;
-Mental ill health, such as dementia, schizophrenia, addictive behaviors; or severe depression (PHQ-9 score more than or equal to 15), severe anxiety (PASS score more than 38).
-Unable to communicate in English;
-Pregnancy or lactation period;
-Skin damage or wound on points;

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Means (standard deviations) or medians (interquartile ranges) will be used to describe variables as appropriate; frequencies and percentages will be used to describe dichotomous or categorical variables.
Paired t-tests will be used to compare baseline characteristics (age, BDI II, SPSS 20, BMI) for comparability between matched pairs, assuming normally distributed differences. Otherwise, the signed Wilcoxon’s rank test will be used instead.
For primary analysis, the difference of PPT between the 2 groups will be analyzed by mixed-effects linear regression model, using group as fixed effect; pair as random effect; and including disease severity, age, the score of BDI II and PASS 20, BMI, menstrual cycle, sleep quality as covariates. Disease severity is defined according to NRS and RDQ score.
For secondary analysis, conditional logistic regression will be used to compare the presence of tissue abnormality, and presence of pain sensitized acupoints between matched pairs with age, the score of BDI II and PASS 20, BMI, menstrual cycle, sleep quality as covariates; Mixed-effects linear regression model described above will be performed to estimate between-group differences of local temperature, electrical conductivity, as well as the correlation between NRS/RDO and PPT on acupoints. Descriptive analysis will be applied to measure any deviation distance from the center of standard acupoint location.
All statistical analyses will be performed by R (version 3.5.1, R Development Core Team, New Zealand, 2018); 2 sided P value of less than 0.05 will be regarded as statistically significant.

Recruitment
Recruitment status
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 outside Australia
Country [1] 21237 0
New Zealand
State/province [1] 21237 0
Otago

Funding & Sponsors
Funding source category [1] 301784 0
University
Name [1] 301784 0
PhD scholarship provided by University of Otago
Address [1] 301784 0
362 Leith St, North Dunedin, Dunedin 9016
Country [1] 301784 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith St, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 302468 0
None
Name [1] 302468 0
Address [1] 302468 0
Country [1] 302468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302497 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 302497 0
362 Leith St, North Dunedin, Dunedin 9016
Ethics committee country [1] 302497 0
New Zealand
Date submitted for ethics approval [1] 302497 0
07/11/2018
Approval date [1] 302497 0
15/05/2019
Ethics approval number [1] 302497 0
H18/125

Summary
Brief summary
The aim of this study is to understand the nature of acupoints in people with chronic low back pain. More specifically, we are interested in how acupoints change under the influence of chronic low back pain. In this study, we will assess reaction to pain and biophysical properties at the most commonly-used ‘routine’ acupoints for chronic low back pain (there are 8 of them).

Trial website
Trial related presentations / publications
Public notes
Chronic low back pain is the dominant cause of disability worldwide, accounting for 7.2% of total disabilities. In New Zealand, the prevalence of chronic low back pain is estimated to be 9.1% in 2013, resulting in a claim of $39.6 million to ACC. Acupuncture apparently provides a number of advantages in treating chronic low back pain, and has been shown to be cost-effective compared with usual care in large scale clinical trials. An acupoint is the best place to stimulate healing using pressure or an acupuncture needle. Choosing correct acupoints is critical to maximizing the effect of acupuncture.
When the body is sick, acupoints will become sensitive: there might include several changes. For instance, it might be easier to feel pain when the acupuncture points are pressed; the local temperature and the local skin’s ability to conduct electricity might change according to the severity of symptoms; the tissue on the points might become harder or the skin colour might change.

Contacts
Principal investigator
Name 90422 0
Prof David Baxter
Address 90422 0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Country 90422 0
New Zealand
Phone 90422 0
+64 03 4797411
Fax 90422 0
Email 90422 0
david.baxter@otago.ac.nz
Contact person for public queries
Name 90423 0
Ms Huijuan Tan
Address 90423 0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Country 90423 0
New Zealand
Phone 90423 0
+64 028 4198260
Fax 90423 0
Email 90423 0
huijuan.tan@postgrad.otago.ac.nz
Contact person for scientific queries
Name 90424 0
Ms Huijuan Tan
Address 90424 0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Country 90424 0
New Zealand
Phone 90424 0
+64 028 4198260
Fax 90424 0
Email 90424 0
huijuan.tan@postgrad.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participants data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following the publication of main results.
Available to whom?
case-by-case basis at the discretion of primary sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by principal investigator
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5846 0
Ethical approval
Citation [1] 5846 0
Link [1] 5846 0
Email [1] 5846 0
Other [1] 5846 0
Summary results
No Results