Complementary medicine

Protocol

Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial

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  1. Zongshi Qin1,2,
  2. Yulong Ding3,
  3. Jiani Wui,
  4. Jing Zhou1,2,
  5. Likun Yang1,
  6. Xiaoxu Liu1,2,
  7. Zhishun Liu1
  1. 1 Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
  2. 2 Beijing Academy of Chinese Medicine, Beijing, China
  3. three Department of Acupuncture, Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, People's republic of china
  1. Correspondence to Dr Zhishun Liu; liuzhishun{at}aliyun.com

Abstract

Introduction Degenerative lumbar spinal stenosis (DLSS) is a major public health problem and the primary reason why older adults seek lumbar spine surgery. Acupuncture may exist effective for DLSS, simply the prove supporting this possibility is still limited.

Methods and analysis A total of 80 participants with DLSS will be randomly allocated to either an acupuncture group or a sham acupuncture (SA) group at a ratio of 1:one. 24 treatments will exist provided over eight weeks. The master issue is the score alter of the Modified Roland-Morris Disability Questionnaire (RMDQ) responses from baseline to week 8. The secondary outcomes include the assessment of lower back pain and leg hurting using the Numeric Rating Scale (NRS), the change in the number of steps per month, and the cess of the specific quality of life using the Swiss Spinal Stenosis Questionnaire (SSSQ). We volition follow-up with the participants until week 32. All of the participants who received allocation volition be included in the statistical analysis.

Ethics/dissemination This protocol has been approved past the Inquiry Ethical Committee of Guang'anmen Hospital (Permission number: 2015EC114) and Fengtai Hospital of Integrated Traditional and Western Medicine (Permission number: 16KE0409). The total data ready will be made available when this trial is completed and published. Applications for the release of data should be made to ZL (primary investigator).

Trial registration number NCT02644746.

  • Lumbar spinal stenosis
  • acupuncture
  • efficacy
  • randomized controlled trial

This is an Open Access article distributed in accord with the Artistic Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original piece of work is properly cited and the employ is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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  • Lumbar spinal stenosis
  • acupuncture
  • efficacy
  • randomized controlled trial

Strengths and limitations of this study

  • This is a placebo-controlled trial using non-penetrating needles, which might provide a valid blinding issue to participants and minimise the placebo outcome.

  • A 24-calendar week follow-up can assess whether a sustained event of acupuncture for degenerative lumbar spinal stenosis can persist for a long period.

  • As acupuncture is a manipulated intervention, information technology is difficult to blind the acupuncturists to the treatment modalities.

Background

Lumbar spinal stenosis (LSS) is one of the major causes of pain and numbness in the dorsum and legs, with degenerative lumbar spinal stenosis (DLSS) as the about common type.1 ,2 DLSS is commonly characterised by macerated available space for the neural and vascular elements in the lumbar spinal culvert secondary to degenerative changes. These changes lead to a variable clinical syndrome such as intermittent claudication and back, gluteal and lower extremity pain and fatigue all of which are accompanied past limited daily function and dumb quality of life.3–5 According to the Framingham study, the prevalence of relative (≤12 mm) and absolute (≤x mm) LSS in a random community population 60–69 years of age was 47.two% and 19.4%, respectively.6 In general, ageing results in spine degeneration afterward the age of 65, and DLSS is the primary reason that people over the age of 65 years seek lumbar spine surgery.5 ,7

According to the recommendations of the Due north American Spine Guild (NASS), treatment options include surgical therapy, epidural steroid injections and physical therapy.8 Randomised trials indicate that for patients severely afflicted by spinal stenosis, surgery offers greater efficacy than non-surgical treatments.9 ,x Even so, the complications and costs of surgery should besides exist considered, especially for older patients.11 In addition, Kovacs et al12 found that after x years of follow-up, patient satisfaction between the surgical and non-surgical groups were similar, suggesting that the outlook for a report examining conservative therapies is promising. Some experts assert that it is necessary to undergo systematic bourgeois therapy earlier resorting to surgical repair. Furthermore, the ineffectiveness of conservative treatment is i of the indications for surgery.13–15 Although epidural steroid injections tin can save pain in the back and legs, this treatment often fails to improve pain in the lower extremity and claudication.16 ,17 For acupuncture, there has been insufficient evidence to either recommend or criticise its use. In 2013, Kim et al18 conducted a systematic review and meta-analysis which found that acupuncture either with electrical stimulation or in combination with other related techniques might be benign compared with acupuncture therapy lonely. Even so, the evidence was poor and limited by trials rated as having a high run a risk of bias and substantial clinical heterogeneity. Thus, their determination could not prove the efficacy of acupuncture for DLSS. One of our previous accomplice studies signified that acupuncture might relieve the symptoms of DLSS.19 In addition, an unpublished pilot study conducted last year included 12 participants too indicated that compared with sham acupuncture (SA), acupuncture can alleviate the hurting symptoms as measured past Modified Roland-Morris Disability Questionnaire (RMDQ) and Numeric Rating Calibration (NRS) later 8 weeks of treatment. Withal, owing to the insufficient sample size and lack of a long-term follow-upwards period, more substantial clinical trials are even so needed to back up the evidence that acupuncture may exist an optional handling for DLSS in the futurity.

Methods

Objective

To appraise the efficacy and safety of acupuncture on relieving the symptoms of DLSS and improving the quality of life of patients with DLSS.

Hypotheses

  1. Compared with SA, acupuncture volition significantly relieve the symptoms of DLSS after an viii-calendar week handling measured past valid instruments.

  2. Acupuncture will have a sustained effect for DLSS later on 8 weeks of treatment.

Report design

This is a randomised, placebo-controlled, observer-blinded and patient-blinded multicentre superiority trial with two parallel groups using a i:1 allocation ratio. The protocol had been adult following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines.twenty ,21 A diagram of the trial design is shown in figure 1.

Participants and recruitment

In total, 80 participants will be recruited through public posters and from the Guang'anmen Infirmary and Fengtai Hospital of Integrated Traditional and Western Medicine website. The clinicians will be responsible for enrolling participants who are willing to undergo acupuncture handling for DLSS. The assistant researchers volition appraise and tape the participants' baseline status. Later the written informed consent has been obtained, eligible participants will be randomly allocated co-ordinate to a group number generated by a 3rd political party.

Randomisation and allocation darkening

The Institute of Clinical Pharmacology affiliated with Guang'anmen Hospital volition be responsible for randomly grouping participants and is involved in neither the handling nor data drove for this study. Using a block size of iv in a scheduled computer-generated randomisation program, the concluding group assignments will exist sealed in opaque envelopes. To ensure the proper management of the randomisation procedure, the sequence numbers will be printed on the outside of the opaque envelope, and the group assignment will exist sealed within. All envelopes will be numbered sequentially. The envelopes will be delivered co-ordinate to the patients' sequence numbers, and the acupuncturist will be informed of the random numbers and grouping assignments past either phone or email.

Blinding

Owing to the characteristics of acupuncture, none of the acupuncturists involved in this trial can be blinded to the assignments. However, the participants volition be blinded as they do not know their assignments, and the SA used in this trial tin can guarantee a good blinding effect every bit the location of the selected acupoints are in the blind spots of participants. The assessors and statisticians for the data collection and assay will be blinded to the assignments. In addition, participants will exist asked to respond the following question during week 8 to test the blinding outcome: 'Do you recall you accept received real acupuncture treatment?' The participants tin can choose 'yes' or 'no' as an answer. Nosotros will analyse the percentage of participants who answered 'yeah' in both groups after the concluding treatment. If the results bear witness no significant difference in the response to this question between the two groups, they could suggest that the blinding effect is sufficient.

Participants

Inclusion criteria

Participants who meet the requirements for a diagnosis of DLSS as defined by the NASS8 besides every bit all of the post-obit weather will be considered for enrolment.

  1. Using the NRS questionnaire to report buttock/leg pain>low dorsum pain>4 points.

  2. A Roland-Morris score of at least vii.

  3. Mild, moderate or severe lumbar central canal spinal stenosis identified by MRI or CT scan. Central stenosis volition be classified mainly based on the mid-sagittal bore measured in millimetres at the narrowest intervertebral level. The classifications are mild (more than 13 mm), moderate (eleven–13 mm) and severe (<xi mm).22

  4. Age 50–80 years.

  5. Signed consent and willingness to participate in the trial.

Exclusion criteria

  1. Congenital stenosis of the vertebral canal, serious indications of DLSS (eg, segmental muscular cloudburst, bowel and float disturbances), lumbar tuberculosis, lumbar vertebral tumours or vertebral torso compression fracture.

  2. Spinal instability requiring surgery.

  3. Severe vascular, pulmonary or coronary artery disease that limits ambulation, including contempo myocardial infarction.

  4. Participants who are cognitively impaired such that they are unable to give informed consent or provide accurate information.

  5. Clinical comorbidities that could interfere with the collection of data concerning pain and function.

  6. Acupuncture treatments inside the past thirty days.

  7. Administration of medications for pain control (eg, non-steroidal anti-inflammatory drugs or herbal anti-inflammatory agents) during the calendar week prior to collecting the baseline.

Intervention

Intervention group

Acupuncturists who accept completed five years of undergraduate written report and take 2 years of clinical experience volition administrate the acupuncture or SA. The intervention protocol and acupoints option were based on the proficient's feel and previous clinical research.nineteen The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) volition be used (table i). All acupoints will exist localised according to the WHO Standard Acupuncture Locations.23 During the treatment, participants volition lie in the prone position, and the acupuncturists volition use 75% alcohol pads to sterilise the skin around the acupuncture points. Subsequently, sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm×40 mm/0.3 mm×75 mm) volition be inserted into the selected acupuncture points, which are covered with agglutinative pads. For the bilateral BL25, the needle will be inserted vertically at ∼40–70 mm to induce a sensation of soreness (de qi). For the other four acupoints (BL23, BL40, BL57 and KI3), the needles will exist inserted to a depth of 10–fifteen mm, gently rotated three times and lifted to achieve de qi. There will be 24 treatment sessions, with 1 session scheduled 3 times a week. Patients will undergo a xxx min treatment per session.

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Table ane

Summary of the acupoints' location

Command group

The acupuncturists will employ blunt tip needles that cannot penetrate the skin or stimulate deep tissues. Thrusting and twisting motions volition exist used by acupuncturists to simulate the handling and assistance in blinding the patients. The sham needle used in this trial had a blunt tip similar to the Streitberger needle,24 which has been proven every bit a useful placebo control.25 Each placebo needle consists of 4 parts: the needle handle, needle body, blunt tip and adhesive pad (an analogy of the placebo needle used in this trial is shown as figure 2). The chosen acupoints, treatment duration and frequency of sessions for participants in the SA group will be the aforementioned as in the acupuncture group.

Issue

Primary outcome

The primary outcome measure is the score change in the Modified Roland-Morris Disability Questionnaire (with scores ranging from 0 to 24 and higher scores suggesting greater impairment) compared with baseline at week 8.

The RMDQ is a reliable and valid dorsum hurting-specific functional status questionnaire. Disability is measured respective to physical part activities and activities of daily living, including eating and sleeping. The RMDQ contains 24 questions, and after each question, the phrase 'caused past low back pain' appears. In this study, nosotros volition modify the in a higher place phrase to 'caused past buttock and leg pain' later on each question, which will be more than suitable for participants who accept sciatica.26 To mensurate the symptoms of the participants with DLSS later viii weeks of treatment, participants will be asked to complete the Chinese version of the RMDQ.

Secondary outcomes

  1. The score alter in the RMDQ compared with baseline at weeks 4, twenty and 32.

  2. The score change in the pain rating of low back, and buttock and leg using the Number Rating Scale (NRS, with scores ranging from 0 to 10 and higher scores indicating greater pain) compared with baseline at weeks four, 8, 20 and 32. The pain symptoms volition exist graded using the 11-grade NRS past the patients themselves.27 ,28 We will offer two scales for the participants each week, including one for measuring buttock and leg pain and some other for measuring low back pain. Participants should answer with the average score of period since the about contempo follow-upwardly. Assessments will be made at baseline, from 1 to 8 weeks, and at 20 and 32 weeks after the beginning treatment.

  3. The score change in the self-paced walking examination (SPWT) compared with baseline at weeks 4, 8, 20 and 32. The walking part of participants with claudication volition be evaluated using the SPWT, which was invented past Bassey et al29 and was initially used to evaluate cardiovascular affliction. Tomkins et al30 adapted the SPWT to appraise the walking function of patients with LSS. In this trial, participants will be required to walk at their customary speed (between eight:30 and 9:30 after breakfast on the weekends), and they volition end when the symptoms of DLSS announced; the number of steps volition be recorded by pedometer.

  4. The score change in the Swiss Spinal Stenosis Questionnaire (SSSQ) will be compared with baseline at weeks 4, viii, 20 and 32. The symptoms and functions will be evaluated using the SSSQ, which consists of three domains: symptom severity (eg, overall pain, pain frequency, numbness, feebleness; with scores ranging from 1 to v and college scores indicating worse symptoms), physical function (walking, activity; with scores ranging from 1 to four and college scores indicating worse role) and satisfaction with the degree of treatment efficacy (with scores ranging from 1 to 4 and higher scores indicating less satisfaction). This assessment volition be completed at baseline and at 4, eight, 20 and 32 weeks afterward the offset treatment.31–33

  5. Patient expectations of the effectiveness of acupuncture will be recorded at baseline. The expectations regarding whether acupuncture might aid alleviate DLSS will be assessed at baseline. This calibration includes four cursory questions to investigate whether patients are confident that the acupuncture treatment will help alleviate their DLSS and whether the degree of expectation can affect the primary outcome: 'Do you lot think acupuncture can piece of work?', 'Do you call up acupuncture can help your DLSS?', 'Which intervention do you adopt?' and 'Did yous receive your preferred intervention?'.

Table 2 presents the data collection times.

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Tabular array 2

Time of information collection

Condom assessment

For rubber cess, acupuncture-related adverse events such as severe sharp pain (visual counterpart scale ≥7), haematomas or bleeding effectually the side of needle, nausea or fainting during treatment, and other discomfort subsequently acupuncture will be assessed throughout the study in both groups. In addition, adverse events unrelated to acupuncture such as the mutual cold, cough, diarrhoea, constipation and headache will too be recorded past the observers.

Information management and monitoring

All investigators who have completed good clinical practice training will independently collect the information and assess the furnishings of the treatments. A remote data capture arrangement will exist used to store data on a password-protected computer that will store recorded data in a secure environs. In principle, clinical information volition not be released without the permission of the chief investigator (ZL), with the exception of an emergency or equally necessary for monitoring and auditing by the data monitoring committee. All paper and electronic versions of the case study form will exist preserved in the secure research archives at Guang'anmen Hospital for 10 years and will just exist viewed by the research team. In addition, an independent data monitoring committee has been established to review the results of any agin events to decide whether the trial should go on. The committee comprises an orthopaedist, a medical statistician and an epidemiologist.

Rescue medication

In full general, ingestion of painkillers is forbidden during the trial because they may potentially effect the accuracy of the data. Notwithstanding, if participants declare that the pain is unbearable during the study period, celecoxib capsules will exist administered (J20030098 Pfizer Pharmaceuticals LLC; 1.two g/box) to alleviate hurting (200 mg by oral fissure once daily for three days). Whatsoever medicine administered should be carefully recorded in the case written report class in addition to any other concomitant medications.

Statistical methods

Sample size

The sample size adding is based on the superiority two-sided exam with the null hypothesis that the divergence betwixt the groups with regard to the score change in the RMDQ from baseline to week 8 is not more 2.25 points. The main outcome is the score change in the RMDQ from baseline to week 8. According to the written report of Patrick et al,26 the minimal clinically important difference (MCID) of the RMDQ is 2–3 points; therefore, we choose 2.25 points as a conservative approximate of the MCID for the RMDQ score. Based on our previous pilot study and assumptions, the hateful reduction of RMDQ score in the acupuncture and SA groups was 4.7 and 2.four, with an SD of three.8 points in both groups. The sample size was calculated using WinPepi software Five.11.6.34 We estimated α=0.05 and β=0.2, assuasive for xv% attrition. Finally, nosotros plan to recruit lxxx participants, xl in each grouping, which can provide 80% power to detect an intergroup difference of more than 2.25 points in the RMDQ.

Statistical assay

Data from the trial will be entered into SPSS software 5.21.0 (IBM SPSS Statistics, IBM Corp, Somers, New York, USA), and information analysis volition exist based on the intention-to-treat analysis data ready, which includes all participants who were assigned to a group. The main objective of this trial is to assess the score modify in the RMDQ betwixt the groups from baseline to week 8. We volition use the independent sample t-test for the analysis, and if the distribution is abnormal, non-parametric Wilcoxon statistics will exist used to test the null hypothesis. For the secondary outcome information provided by scales or questionnaires such every bit the NRS, SPWT and SSSQ, an contained sample t-test will be used for comparing between the independent samples, and non-parametric tests may also exist used in case of abnormal distribution. Linear regression will exist used to explore the human relationship between the expectations and chief outcomes as well every bit to examine whether the patients' expectations can bear on their treatment. For whatever random data missing, a multiple imputation will be used; yet, we will effort to ensure that all data points analysed are bodily collected data. A χ2 test will exist used to appraise the satisfaction (assessed by third domain of SSSQ) and condom of the treatments.

Research ethics

This trial is in accordance with the Announcement of Helsinki35 and has been approved past the Research Ethical Commission of Guang'anmen Hospital affiliated with the China Academy of Chinese Medicine Science (Permission number: 2015EC114) and Fengtai Hospital of Integrated Traditional and Western Medicine (Permission number: 16KE0409). All participants will exist required to provide written informed consent prior to enrolment in the trial.

Discussion

To date, in the bulk of randomised controlled trials that have compared basic acupuncture to other types of acupuncture for treating DLSS, it is difficult to assess the efficacy of acupuncture.18 In this trial, nosotros designed an SA group as a controlled comparison group to place the efficacy of existent acupuncture. In acupuncture inquiry, the utilise of an SA control is helpful for determining the efficacy of acupuncture for treating a disorder. However, attributable to the characteristics of acupuncture, it is hard to use a placebo needle on patients. Based on a randomised controlled cross-over trial, the SA that volition be implemented in this study will serve as a valid control25 because it can produce a expert blinding effect to patients from two groups. This might residue the placebo effect betwixt the two groups and reveal the efficacy of acupuncture for DLSS.

Additionally, we selected RMDQ equally the master outcome in combination with MCID to calculate the sample size for this trial, which will better the analysis in reaching a final conclusion. RMDQ is one of the nearly commonly used instruments for lower dorsum pain.36 Owing to its elementary and readily understood questions, the RMDQ assessment is easy to complete. Other widely used scales and questionnaires such as the NRS, SPWT and SSSQ will as well play auxiliary roles in evaluating the results regarding whether acupuncture can ameliorate the symptoms and ameliorate the quality of life for patients with DLSS.

Finally, we established a 24-calendar week follow-up (weeks 9–32) to detect the sustained effects of acupuncture on DLSS subsequently the stop of the treatment sessions. There are still limitations that should be noted. As acupuncture is a manipulated intervention, blinding for acupuncturists is difficult to implement. However, the outcome evaluators in this trial will exist blinded to assignment to decrease the potential bias. Additionally, because the pilot study that was used to judge the sample size of this trial was small, there might be an overestimation of the acupuncture consequence. At the stop of this trial, nosotros hope that the results will provide more reliable evidence and clarify the value of acupuncture as a treatment for patients with DLSS.

Acknowledgments

The authors would like to express their sincere thanks to Professor Lawrence Mbuagbaw (Department of Clinical Epidemiology and Biostatistics, McMaster University) for his help in improving the methodological quality of this manuscript. The authors would as well like to accept this opportunity to bear witness their sincere gratitude to Mr Brendan Melchiorri (Department of Advanced International Studies, Johns Hopkins Academy), for his advice and improvements to this manuscript.

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Published by the BMJ Publishing Group Limited. For permission to employ (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open up Access commodity distributed in accordance with the Artistic Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the utilise is non-commercial. Encounter: http://creativecommons.org/licenses/past-nc/iv.0/