Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000534583
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
27/05/2015
Date last updated
10/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the dose of Traditional Chinese Medicine acupuncture in addition to usual care affect outcomes for adults with chronic low back pain?
Scientific title
For adults with chronic low back pain, does the number of sessions of Traditional Chinese Medicine acupuncture in addition to usual care affect back pain and function outcomes? A randomized controlled feasibility study
Secondary ID [1] 286714 0
Nil
Universal Trial Number (UTN)
U1111-1167-0957
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 295073 0
Condition category
Condition code
Musculoskeletal 295325 295325 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 295326 295326 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The addition of Traditional Chinese Medicine (TCM) acupuncture to usual care for chronic low back pain.

All participants will be advised to continue their maintenance programme during the intervention period. This may include any pragmatic management (medications, or non-pharmacological therapy e.g. manual therapy) as directed by any health practitioner (e.g. general practitioner, physiotherapist, chiropractor, or osteopath).

In addition to usual care as described above, participants will receive either 4 sessions, 7 sessions or 10 sessions of TCM acupuncture:
Arm 1 (n=15): 4 sessions of TCM acupuncture over 2 weeks;
Arm 2 (n=15): 7 sessions of TCM acupuncture over 3.5 weeks;
Arm 3 (n=15): 10 sessions of TCM acupuncture over 5 weeks.

TCM acupuncture will be performed by a registered acupuncturist. Each participant will be treated with a combination of local and distant points, including BL 23 (Shenshu) and BL 25 (Dachangshu), which are needled bilaterally, low back Ashi points, BL 40 (Weizhong), and KI 3 (Taixi). Additionally, up to four supplementary acupoints for the possible concomitant buttock or leg pain are allowed, which may include BL 36 (Chengfu), BL37 (Yinmen), BL 54 (Zhibian), GB 30 (Huantiao), GB 31 (Fengshi), BL 57 (Chengshan), and BL 60 (Kunlun).

Treatments will be performed twice weekly. Acupuncture will be administered with the participant in a prone position on the treatment couch. Alcohol swabs will be applied to the skin prior to needle insertion if necessary (e.g. immuno-compromised participants). Sterile filiform, single-used needles (0.25 mm x 40 mm, 0.30 mm x 50 mm, and 0.30 mm x 75 mm, Hwato brand, Suzhou, China) will be used to penetrate the skin. The depth of insertion will depend on the point location, the participant’s age and physical condition and response to the needles. Selected acupoints will be stimulated manually by gentle rotation of the needles with lift and thrust until the participant achieves a de qi sensation, and then every 5 minutes to ensure de qi is still present. A maximum of 10 needles will be inserted per session and left in place for approximately 20 minutes. Moxibustion and other interventions (e.g. cupping, scraping, and bloodletting) are excluded from this trial.
Intervention code [1] 291869 0
Treatment: Other
Comparator / control treatment
There are 3 treatment groups being compared in this trial, as described in the 'Description of intervention' field above. All groups will receive an active intervention, and therefore none of the groups can be described as the ‘standard, control or comparator’.
Control group
Dose comparison

Outcomes
Primary outcome [1] 295067 0
Acceptability of the treatment to participants
i. Number of sessions attended
ii. Reasons for non-attendance or early withdraw from treatment
iii. Adherence to treatment protocol
Timepoint [1] 295067 0
During intervention
Primary outcome [2] 295068 0
Feasibility of the recruitment process
i. Number of participants attending screening assessment
ii. Number of participants willing to join the trial
iii. Number of participants willing to be randomized into the trial from amongst those eligible
iv. Reasons for non-participation and ineligibility
Timepoint [2] 295068 0
Before intervention
Primary outcome [3] 295069 0
Feasibility of the measurement tools
i. Difficulty in questionnaire completion at all time points
ii. Time taken to complete questionnaires at all time points
iii. Number of missing items
iv. Follow up rates
Timepoint [3] 295069 0
At baseline, completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [1] 314697 0
Back specific function: Roland-Morris disability Questionnaire (RDQ) is used to measure the functional limitations experienced by participants, and the higher the score the more severe the impairment. It consists of 24 items, each addresses the individual's activity limitations due to low back pain (e.g. walking, standing, sitting, bending over, lying down, and other daily activities).
Timepoint [1] 314697 0
At baseline, completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [2] 314698 0
Pain intensity: measured by the standard 100-mm Visual Analogue Scale (VAS), where 0 represents no pain and 100 is the worst pain ever.
Timepoint [2] 314698 0
At baseline, during intervention (pre and post each acupuncture session), completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [3] 314699 0
Pain bothersomeness: participants will be asked to rate how bothersome their low back pain has been over the past week on a 0 to 10 scale where 0 indicates "not at all bothersome" and 10 "extremely bothersome".
Timepoint [3] 314699 0
At baseline, completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [4] 314700 0
Generic health status: the Short-Form 12 (SF-12V2TM) is a self-administered questionnaire used to assess the participant’s health status and quality of life with higher scores indicating a better level of functioning.
Timepoint [4] 314700 0
At baseline, completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [5] 314701 0
Activity disability: restriction of activity due to low back pain is measured with a questionnaire of three separate questions taken from the United States National Health Interview Survey about the number of days spent in bed, lost from work or school or cut down on usual activity during the past week.
Timepoint [5] 314701 0
At baseline, completion of intervention, and 6 weeks and 12 weeks post randomization.
Secondary outcome [6] 314702 0
Patient satisfaction: the simple question, “All things considered, how satisfied are you with the care you received?” is rated on an eight-point rating scale (1 = extremely satisfied, 2 = very satisfied, 3 = somewhat satisfied, 4 = mixed (approximately equal satisfaction and dissatisfaction), 5 = somewhat dissatisfied, 6 = very dissatisfied, 7 = extremely dissatisfied, 8 = not sure/no opinion). In addition, an open-ended question regarding participant’s comments on acupuncture treatment will be obtained.
Timepoint [6] 314702 0
On completion of intervention.
Secondary outcome [7] 314832 0
Adverse reactions: an adverse reaction is described as any undesired harmful sign, symptom or disease (e.g. needle-site pain, hematoma, or skin infection) resulting from acupuncture, which could reasonably be related to the procedure. Participants will be asked about any adverse reaction experienced from the previous session at each visit and 1 week after the final acupuncture needling session. Detailed information about the adverse reaction will be recorded on an adverse reaction form.
Timepoint [7] 314832 0
During intervention, and 1 week after the final acupuncture needling session.

Eligibility
Key inclusion criteria
Participants are eligible if they:
(1) are 18 years or older;
(2) have a history of low back pain of more than 3 months in the lumbosacral region (below the 12th costal margin and above the inferior gluteal folds) with or without radiating leg pain;
(3) report a score of greater than 4 on the modified Roland-Morris disability questionnaire (RDQ) at randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
(1) history of any known serious spinal disorders, including malignancy, neoplasm, infection, congenital spinal deformity, spinal fracture, inflammatory arthritis, spondylolisthesis, ankylosing spondylitis, cauda equine syndrome;
(2) history of spinal surgery or currently wait-listed for spinal surgery;
(3) previous attendance at a specialised pain clinic or use of morphine (or similar) for low back pain in the past 1 year;
(4) unresolved litigation or compensation claim;
(5) severe psychological disorders or dementia;
(6) use of acupuncture for low back pain in the past 1 year;
(7) prolonged use of steroids or current use of anti-coagulant medication;
(8) any bleeding disorders;
(9) fear of needles;
(10) history of any systematic medical conditions precluding participation in this trial (e.g. cardiovascular, liver or kidney diseases, deep vein thrombosis, epilepsy);
(11) postpartum, pregnancy or intended pregnancy;
(12) unable to communicate in English or Mandarin.

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)
Participants will be recruited from the Dunedin community through posting flyers about the study around the university campus, community centres, waiting rooms in medical centres and in the School of Physiotherapy Clinics, as well as advertisements in university staff newsletters, local newspapers and social networking sites as appropriate.

Interested participants will be asked to contact the clinical research administrator for further information, and will be provided with the Information Sheet regarding the study procedure. If still interested, they will make the first appointment for a visit to the School of Physiotherapy. At this appointment, the participant will undergo a screening procedure to confirm the final eligibility for participation. The rationale of the treatment and any questions from participants will be explained in detail by the Primary Investigator before written informed consent is obtained.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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 30 participants is considered appropriate and achievable in accordance with the time limitation. Taking into account the potential for withdrawal or incomplete data may be 30%, it is anticipated that 45 participants will be recruited.

Primary outcomes will be measured by summarising the relevant data at the end of the study. Secondary outcomes will be analysed using SPSS (version 22.0) on an intention-to-treat basis. Since this is a feasibility study, tests for significance will not be performed. Data will be reported as mean +/- standard deviation. Repeated measures ANOVA will be used to compare pre-test and post-test mean scores between groups with the baseline outcome measure as the covariate. The Mann-Whitney U-test will be used to establish the differences between groups for difficulty in questionnaires completion, patient satisfaction and adverse reactions. In addition, a power analysis will be completed using the minimum clinically important change of 2.5 points between groups on the Roland-Morris disability Questionnaire (RDQ) scale, at an alpha of 0.05 and power of 90%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2015
Actual
4/06/2015
Date of last participant enrolment
Anticipated
2/12/2015
Actual
10/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 6882 0
New Zealand
State/province [1] 6882 0
Otago

Funding & Sponsors
Funding source category [1] 291279 0
University
Name [1] 291279 0
University of Otago- School of Physiotherapy
Country [1] 291279 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] 289954 0
None
Name [1] 289954 0
Address [1] 289954 0
Country [1] 289954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292845 0
Health and Disability Ethics Committees
Ethics committee address [1] 292845 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292845 0
New Zealand
Date submitted for ethics approval [1] 292845 0
14/03/2015
Approval date [1] 292845 0
14/05/2015
Ethics approval number [1] 292845 0
15/NTB/54

Summary
Brief summary
This is a pragmatic parallel three-armed randomized controlled feasibility study to provide the rationale for and method to be used for a full scale trial.

Forty-five participants with chronic low back pain will be recruited from the Dunedin community, and randomized on a 1:1:1 basis to receive usual care plus either 4 sessions (n=15), 7 sessions (n=15), or 10 sessions (n=15) of acupuncture interventions. Primary outcomes include the acceptability of and adherence to different numbers of sessions 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. Secondary outcomes include back specific function, pain intensity and bothersomeness, generic health status, activity disability, and patient satisfaction. Follow up questionnaires will be collected at discharge, and 6 weeks and 12 weeks post randomization.

The information obtained from this feasibility study will inform the decision to conduct a full-scale randomized controlled trial to definitively test the dose dependence of acupuncture. Findings will add to the current (limited) body of high quality evidence that is available on the optimal number of sessions of acupuncture in the management of chronic low back pain as well as being clinically relevant to clinicians, researchers, and policy makers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57286 0
Ms Lizhou Liu
Address 57286 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 57286 0
New Zealand
Phone 57286 0
+64 34795694
Fax 57286 0
Email 57286 0
lizhou.liu@otago.ac.nz
Contact person for public queries
Name 57287 0
Ms Lizhou Liu
Address 57287 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 57287 0
New Zealand
Phone 57287 0
+64 34795694
Fax 57287 0
Email 57287 0
lizhou.liu@otago.ac.nz
Contact person for scientific queries
Name 57288 0
Ms Lizhou Liu
Address 57288 0
325 Great King Street,
School of Physiotherapy,
University of Otago,
Dunedin 9016
Country 57288 0
New Zealand
Phone 57288 0
+64 34795694
Fax 57288 0
Email 57288 0
lizhou.liu@otago.ac.nz

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No Supporting Document Provided



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