Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619000614190
Ethics application status
Approved
Date submitted
31/01/2019
Date registered
24/04/2019
Date last updated
3/12/2021
Date data sharing statement initially provided
24/04/2019
Date results information initially provided
3/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Detecting the change of acupuncture points in patients with chronic low back pain
Query!
Scientific title
Detection of sensitization phenomena at disease-related acupoints in patients with chronic low back pain: Protocol for a matched case-control study
Query!
Secondary ID [1]
297231
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
chronic low back pain
311295
0
Query!
Condition category
Condition code
Alternative and Complementary Medicine
309920
309920
0
0
Query!
Other alternative and complementary medicine
Query!
Musculoskeletal
309922
309922
0
0
Query!
Other muscular and skeletal disorders
Query!
Neurological
310014
310014
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
313510
0
Not applicable
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
318875
0
Query!
Timepoint [1]
318875
0
immediate assessment
Query!
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.
Query!
Assessment method [1]
366298
0
Query!
Timepoint [1]
366298
0
immediate assessment
Query!
Secondary outcome [2]
366299
0
Deviation distance between the center of standard acupoint location and sensitized point: will be assessed by tape.
Query!
Assessment method [2]
366299
0
Query!
Timepoint [2]
366299
0
immediate assessment
Query!
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.
Query!
Assessment method [3]
366300
0
Query!
Timepoint [3]
366300
0
immediate assessment
Query!
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.
Query!
Assessment method [4]
366301
0
Query!
Timepoint [4]
366301
0
immediate assessment
Query!
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.
Query!
Assessment method [5]
366302
0
Query!
Timepoint [5]
366302
0
immediate assessment
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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;
Query!
Study design
Purpose
Natural history
Query!
Duration
Cross-sectional
Query!
Selection
Case control
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Means (standard deviations) or medians (interquartile ranges) were used to describe continuous variables as appropriate; frequencies and percentages were used to describe dichotomous or categorical variables.
Descriptive statistics were used to describe demographics and patient characteristics. In addition, paired t-tests were used to compare baseline characteristics (age, height, weight, BMI, PHQ-9, PASS 20) for comparability between matched pairs, assuming normally distribution within each group. Otherwise, signed Wilcoxon's rank tests were used instead.
For primary analysis, the difference of PPT between two groups was analyzed by paired at-test when data were normally distributed, otherwise, signed Wilcoxon's rank test was used.
For secondary analysis, paired t-tests or signed Wilcoxon's rank tests were performed to estimate between-group differences of local temperature and electrical conductance as appropriate. McNemar's tests were used to compare the presence of change of points' receptive fields between matched pairs; if some cell values in contingency table were added to be 0, descriptive analyses were applied instead. Descriptive statistics were used to describe the presence of morphology change; Outlier values were defined by boxplot, and handled with multiple imputation method.
All statistical analyses were performed using R (version 3.5.1, R Development Core Team, New Zealand, 2018); 2 sided P value of less than 0.05 was regarded as statistically significant.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
6/05/2019
Query!
Actual
12/08/2019
Query!
Date of last participant enrolment
Anticipated
16/12/2019
Query!
Actual
13/12/2019
Query!
Date of last data collection
Anticipated
16/12/2019
Query!
Actual
13/12/2019
Query!
Sample size
Target
32
Query!
Accrual to date
Query!
Final
32
Query!
Recruitment outside Australia
Country [1]
21237
0
New Zealand
Query!
State/province [1]
21237
0
Otago
Query!
Funding & Sponsors
Funding source category [1]
301784
0
University
Query!
Name [1]
301784
0
PhD scholarship provided by University of Otago
Query!
Address [1]
301784
0
362 Leith St, North Dunedin, Dunedin 9016
Query!
Country [1]
301784
0
New Zealand
Query!
Primary sponsor type
University
Query!
Name
University of Otago
Query!
Address
362 Leith St, North Dunedin, Dunedin 9016
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
302468
0
None
Query!
Name [1]
302468
0
Query!
Address [1]
302468
0
Query!
Country [1]
302468
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
302497
0
University of Otago Human Ethics Committee (Health)
Query!
Ethics committee address [1]
302497
0
362 Leith St, North Dunedin, Dunedin 9016
Query!
Ethics committee country [1]
302497
0
New Zealand
Query!
Date submitted for ethics approval [1]
302497
0
07/11/2018
Query!
Approval date [1]
302497
0
15/05/2019
Query!
Ethics approval number [1]
302497
0
H18/125
Query!
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).
Query!
Trial website
Query!
Trial related presentations / publications
Query!
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.
Query!
Contacts
Principal investigator
Name
90422
0
Prof David Baxter
Query!
Address
90422
0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Query!
Country
90422
0
New Zealand
Query!
Phone
90422
0
+64 03 4797411
Query!
Fax
90422
0
Query!
Email
90422
0
[email protected]
Query!
Contact person for public queries
Name
90423
0
Ms Huijuan Tan
Query!
Address
90423
0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Query!
Country
90423
0
New Zealand
Query!
Phone
90423
0
+64 028 4198260
Query!
Fax
90423
0
Query!
Email
90423
0
[email protected]
Query!
Contact person for scientific queries
Name
90424
0
Ms Huijuan Tan
Query!
Address
90424
0
School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016
Query!
Country
90424
0
New Zealand
Query!
Phone
90424
0
+64 028 4198260
Query!
Fax
90424
0
Query!
Email
90424
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Individual participants data underlying published results only
Query!
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following the publication of main results.
Query!
Available to whom?
case-by-case basis at the discretion of primary sponsor
Query!
Available for what types of analyses?
only to achieve the aims in the approved proposal
Query!
How or where can data be obtained?
access subject to approvals by principal investigator
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5846
Ethical approval
376841-(Uploaded-15-11-2019-14-55-36)-Study-related document.pdf
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.
Download to PDF