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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

3/12/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic low back pain

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Musculoskeletal

Other muscular and skeletal disorders

Neurological

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]

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]

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]

immediate assessment

Secondary outcome [1]

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]

immediate assessment

Secondary outcome [2]

Deviation distance between the center of standard acupoint location and sensitized point: will be assessed by tape.

Timepoint [2]

immediate assessment

Secondary outcome [3]

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]

immediate assessment

Secondary outcome [4]

Local temperature at acupoints: MobIR® M8 Thermal Camera (Wuhan Guide Infrared Co., Ltd., China; See Figure 3) will be used for thermography.

Timepoint [4]

immediate assessment

Secondary outcome [5]

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]

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

Sex

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) 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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/05/2019

Actual

12/08/2019

Date of last participant enrolment

Anticipated

16/12/2019

Actual

13/12/2019

Date of last data collection

Anticipated

16/12/2019

Actual

13/12/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

PhD scholarship provided by University of Otago

Address [1]

362 Leith St, North Dunedin, Dunedin 9016

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

362 Leith St, North Dunedin, Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

07/11/2018

Approval date [1]

15/05/2019

Ethics approval number [1]

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

Prof David Baxter

Address

School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016

Country

New Zealand

Phone

+64 03 4797411

Fax

david.baxter@otago.ac.nz

Contact person for public queries

Name

Huijuan Tan

Address

School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016

Country

New Zealand

Phone

+64 028 4198260

Fax

huijuan.tan@postgrad.otago.ac.nz

Contact person for scientific queries

Name

Huijuan Tan

Address

School of Physiotherapy, University of Otago,
325 Great King St, North Dunedin, Dunedin 9016

Country

New Zealand

Phone

+64 028 4198260

Fax

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?

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.

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