Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001426875p
Ethics application status
Submitted, not yet approved
Date submitted
8/09/2021
Date registered
21/10/2021
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture at tender acupoints for chronic low back pain: a feasibility study investigating the impact of acupuncture on back pain and physical function.
Scientific title
Sensitized points acupuncture versus routine integrative acupuncture for chronic low back pain: a randomized-controlled feasibility study investigating the impact of two different acupuncture protocols on back pain and physical function.
Secondary ID [1] 305245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 323522 0
Condition category
Condition code
Alternative and Complementary Medicine 321080 321080 0 0
Other alternative and complementary medicine
Musculoskeletal 321081 321081 0 0
Other muscular and skeletal disorders
Anaesthesiology 321313 321313 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two groups, each group will use different acupuncture protocols. Experimental treatment will be simple acupuncture treatment on tender acupuncture points.
Pain-sensitized points around bilateral BL 23, BL 25, BL 40 will be chosen as the main acupoints. In addition, up to two adjunct acupoints will be chosen from pain-sensitized sites around bilateral Jiaji Points along L1-L5 vertebrae.
Treatment will be performed by a formally trained acupuncturist (H.T.), with 5 years' clinical experience. Patients will be asked to maintain a prone position for treatment. After disinfecting skin surface by alcohol swab, selected points will be stimulated by insertion of a sterile, single-use filiform acupuncture needle (Hwato needle, Suzhou, China; 25-40 mm in length; 0.25 mm in diameter). It is generally accepted that needles of 40 mm length should be used in the lumbar area, while needles of 25 mm should be placed in the extremities. Exceptionally, for underweight participants (BMI < 18.5 kg/m²), only 25 mm needles will be administered to ensure safety. After needling, the acupuncturist will continue stimulation to achieve Deqi sensation, which is a sensation of numbness, soreness and distension, indicating the stimulation is effective. Needles will be retained for 30 minutes, during which manual stimulation (lifting-thrusting, and twirling method) will be used every 10 minutes to maintain the sensation of Deqi. Each treatment session will take around 50 minutes.
Treatment will be administered at an accredited acupuncture clinic in Dunedin for 8 sessions, twice per week, for four consecutive weeks. Treatment log will be filled by acupuncturist to monitor participants' adherence to the intervention.
Intervention code [1] 321639 0
Treatment: Other
Comparator / control treatment
Control treatment will be a package of care based on Traditional Chinese Medicine (TCM), it will include standard acupuncture and dry cupping.
1. Acupuncture
Bilateral BL 23, BL 25, BL 40 will be chosen as main acupoints, an up to two adjunct acupoints will be chosen according to TCM syndrome differentiation. Acupuncture needles will be manipulated as described above for the experimental group by acupuncturist (H.T.). Acupuncture will take around 40 minutes for each session.
2. Cupping
After removing needles, dry cupping will be performed as an adjunct method to routine acupuncture by the same acupuncturist above. Vacuum suction cupping will be selected as it's more practical in quantifying degree of stimulation. Four round-shaped plastic cups with internal diameter of 57 mm (GuoYiYan vacuum cups, Beijing, China) will be placed bilaterally in the lumbar region from L1 To L5 vertebrae, with cups 3 cm apart. A manual pump will be used to produce negative pressure inside cups. Suction force is suggested to between 300 to 500 millibars (medium force) for musculoskeletal pain, which equates to three suctions produced by the pump. Generally, cups will be retained for 10 minutes; however, should participants report discomfort during this period, cups will be removed immediately.
Acupuncture will be administered for 8 sessions, twice per week, for four consecutive weeks. Cupping will be performed once per week following the second acupuncture session of each week, as it takes time to resolve the bruising produced by the cups.
Each session will take around 40 to 50 minutes in total, depending on whether or not practice cupping. The overall treatment period will be 4 weeks. Treatment will be administered at the same clinic mentioned in experimental group.
Treatment log will be filled by acupuncturist to monitor participants' adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 328864 0
Recruitment rate: will be assessed by calculating the average number of participants being recruited per month, this will be determined by review of study enrolment logs.
Timepoint [1] 328864 0
Recruitment rate will be assessed at baseline
Primary outcome [2] 329104 0
Treatment compliance: will be assessed by audit of study records
Timepoint [2] 329104 0
will be assessed after each treatment session and at discharge.
Primary outcome [3] 329105 0
Participant retention rate: will be assessed by audit of study records
Timepoint [3] 329105 0
Will be assessed on a weekly basis during treatment, at discharge and follow-up.
Secondary outcome [1] 400674 0
Numeric Pain Rating Scale (NPRS): NPRS is one of the most frequently used instruments in assessment of pain severity. It's an 11-point numeric scale scoring from 0 to 10 points. "0" represents "no pain", and "10" represents "the worst pain imaginable". Participants will be asked to rate their current pain intensity, the worst pain intensity in the last 24 hours, and the best pain intensity in the last 24 hours on three independent scales. The final score will be calculated as the average of three ratings.
Timepoint [1] 400674 0
At baseline, On a weekly basis during treatment, at discharge and follow up
Secondary outcome [2] 400675 0
Roland-Morris Disability Questionnaire (RMDQ): RMDQ is a self-administered questionnaire that evaluate the impairment of physical function results from low back pain. This scale contains 24 items, each item scores 1 point if in line with the description.
Timepoint [2] 400675 0
At baseline, On a weekly basis during treatment, at discharge and follow up
Secondary outcome [3] 400676 0
The short-form version of the Depression Anxiety Stress Scales (DASS-21): DASS-21 is the short-form of full DASS scale, which enables assessment on three dimensions: depression, anxiety and stress, and each subscale contains seven items.
Timepoint [3] 400676 0
At baseline, On a weekly basis during treatment, at discharge and follow up
Secondary outcome [4] 400677 0
12-Item Short-Form Health Survey (SF-12): SF-12 health survey is an instrument to assess physical and mental health of patients living with chronic diseases.
Timepoint [4] 400677 0
At baseline, at discharge and follow up
Secondary outcome [5] 400679 0
Utility of Combined Treatments: Patients with unendurable pain during 4-week episode of treatment will be allowed to take in pain-killer following guidance from physician. In addition, other helpful treatments will be allowed during follow-up. The percentage of participants who receive supplementary treatments in each group will be calculated. This will be assessed by participant self report.
Timepoint [5] 400679 0
On a weekly basis during treatment, at discharge and follow up
Secondary outcome [6] 400680 0
Client Satisfaction Questionnaire (CSQ-8): It estimates participants' attitude towards treatment they received. It contains eight items displayed in 4-point Likert Scale format.
Timepoint [6] 400680 0
At discharge
Secondary outcome [7] 401497 0
Consent rate: will be assessed by calculating the proportion of participants who are eligible and consent to take part in study out of all participants who have been screened, as determined by review of study enrolment logs.
Timepoint [7] 401497 0
This is a primary outcome, will be assessed at baseline.
Secondary outcome [8] 401498 0
Adverse event rate: will be assessed by visual observation upon removal of needles, and by seeking participants’ comments.
This study is safe, and risks to participants are considered minimal. For acupuncture treatment, after putting in the needles, the researcher will carefully adjust the needles in order to achieve the sensation of Deqi. For those participants who are receiving acupuncture for the first time, this might feel like mild discomfort; however, the discomfort will disappear after a few minutes. One possible side effect to acupuncture treatment is slight bleeding / bruise at the site of needling, but this is uncommon and minimal. One of the two groups of patients will receive cupping in addition to acupuncture. A common side effect of cupping is temporary bruising. This is normal and happens to all patients having cupping therapy. It won’t cause any discomfort, and will disappear within a week.
Timepoint [8] 401498 0
This is a primary outcome, will be assessed after each treatment session and at discharge.
Secondary outcome [9] 401499 0
Time spent in each session: will be assessed by audit of study records
Timepoint [9] 401499 0
This is a primary outcome, will be assessed after each treatment session and at discharge
Secondary outcome [10] 401500 0
Time spent in filling in questionnaires: each time will be recorded by researcher, and average time spent in filling in questionnaires will be calculate.
Timepoint [10] 401500 0
This is a primary outcome, will be assessed after each treatment session and at discharge
Secondary outcome [11] 401501 0
Completion of the outcome measures: will be assessed by audit the completion of questionnaires
Timepoint [11] 401501 0
This is a primary outcome, will be assessed on a weekly basis during treatment, at discharge and follow-up

Eligibility
Key inclusion criteria
(1) Participants should be adults (aged equal to or more than 18 years old);
(2) Have chronic low back pain (cLBP, with or without leg pain) for more than 3 months;
(3) The average score of Numeric Pain Rating Scale (NPRS) is more than 3 points out of a maximum 10 points;
(4) Agree to sign informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they report any of the following conditions:
(1) Serious spinal disorders including malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression;
(2) Scheduled surgery;
(3) Received acupuncture in the last 4 weeks;
(4) Serious internal disorders: respiratory, circulatory, endocrine, system diseases, etc;
(5) Serious mental illness that have a restricted ability to make independent decisions about their participation;
(6) Unable to communicate in English or Chinese;
(7) Clotting disorders, or taking anticoagulant agent;
(8) Current or scheduled pregnancy, lactation period.

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)
To ensure concealment of allocation from the Primary Investigator, who will determine eligibility of participants for entry in the trial, sequentially numbered, sealed, opaque envelops will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be via a computer-generated random allocation sequence prepared prior to participant enrolment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This will be a two-arm, assessor-blind, non-inferiority feasibility study to investigate the feasibility of a trial of sensitized-points acupuncture and routine integrative acupuncture for cLBP.
Participants (n=30) will be recruited in Dunedin community via study flyers distributed around campus, community centers, and waiting rooms in medical centers; online advertisements will be posted on social media platforms such as Facebook, Instagram, Twitter, etc. Participants will be randomly assigned in a 1:1 ratio into two groups. Each group will receive 8 sessions of sensitized-points acupuncture or routine integrative acupuncture, respectively. Treatments will be conducted twice per week, for 4 weeks. Outcomes will be assessed at baseline, during treatment (after completion of the 2nd, 4th, and 6th treatment session), post-treatment (after completion of the 8th treatment session), and follow-up (week 12).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this study is a preliminary study to inform the feasibility of a powered randomized controlled trial, no sample size calculation has been carried out. Based on the results of a previous study, a sample size of 24 participants is considered appropriate. Taking into account the potential for withdrawal or incomplete data may be 20%, it is anticipated that 30 participants will be recruited. In each group, there will be 15 participants.

In descriptive statistics, mean (standard deviation, SD) or median (interquartile range, IQR) will be used to describe continuous outcomes according to the normality of the distribution. Frequency will be used to describe categorical outcomes. Tables and graphs will be used to present the characteristics of the dataset when appropriate.
Primary analysis will be the feasibility assessment by calculating the percentages of consent rate, treatment compliance, adverse events rate, completion of questionnaires, participants' retention rate; as well as average number of participants recruited per month, average time spent in each session and questionnaire completion. With sufficient data, between-group comparisons will be carried out using either Pearson's Chi-square analysis or Fisher's test.
As a feasibility study, descriptive analysis will be applied to clinical data, rather than hypothesis testing. Changes of secondary outcomes before, during, and after treatment will be described. In addition, effects sizes will be calculated to carry out power analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 24102 0
New Zealand
State/province [1] 24102 0
Otago

Funding & Sponsors
Funding source category [1] 309618 0
University
Name [1] 309618 0
University of Otago- School of Physiotherapy
Country [1] 309618 0
New Zealand
Primary sponsor type
University
Name
University of Otago- School of Physiotherapy
Address
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 310639 0
None
Name [1] 310639 0
Address [1] 310639 0
Country [1] 310639 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309392 0
Health and Disability Ethics Committees
Ethics committee address [1] 309392 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 309392 0
New Zealand
Date submitted for ethics approval [1] 309392 0
13/09/2021
Approval date [1] 309392 0
Ethics approval number [1] 309392 0
NA

Summary
Brief summary
This will be a two-arm, assessor-blind, non-inferiority feasibility study, Participants (n=30) will be randomly assigned in a 1:1 ratio into two groups. Each group will receive a 4-week course of sensitized-points acupuncture or routine integrative acupuncture (routine acupuncture plus dry cupping), respectively. Treatments will be conducted twice per week. The primary outcome measures include the acceptability of and adherence to different modalities of acupuncture treatment for chronic low back pain, and the feasibility of the recruitment approaches and completion of the outcome measures specific to the trial. This feasibility study will provide the rationale for and method to a randomized controlled trial planned for the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113994 0
Prof David Baxter
Address 113994 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 113994 0
New Zealand
Phone 113994 0
+64 03 4797411
Fax 113994 0
Email 113994 0
[email protected]
Contact person for public queries
Name 113995 0
Ms Huijuan Tan
Address 113995 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 113995 0
New Zealand
Phone 113995 0
+64 022 0768652
Fax 113995 0
Email 113995 0
[email protected]
Contact person for scientific queries
Name 113996 0
Ms Huijuan Tan
Address 113996 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 113996 0
New Zealand
Phone 113996 0
+64 022 0768652
Fax 113996 0
Email 113996 0
[email protected]

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)?
Available for 5 years after publication of main results
Available to whom?
The data will be available to the public via publication
Available for what types of analyses?
None specific
How or where can data be obtained?
Ask for approval from principal investigator, email: [email protected]


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.