We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (−33.9; 605.5)
In Western countries, chronic low back pain is a major health concern affecting the quality of life and productivity. Low back pain has a high economic impact. More than 70% of the population in industrialised countries is affected by low back pain [
Complementary and alternative medicine (CAM) therapies are widely used [
The practice of acupuncture has traditionally been based on the Chinese medical system of diagnosing “patterns of disharmony” where identifying the pattern determines the appropriate treatment principle [
The aim of our randomized controlled trial is to compare a standardized acupuncture that is based on evidence from previous acupuncture studies with individualized acupuncture based on the theory of Chinese medicine in patients with chronic low back pain.
We performed a randomized controlled single-blind trial with treatment duration of eight weeks and a total observation time of 26 weeks per patient to compare the effectiveness of standardized with individualized acupuncture. Participants were blinded to group allocation.
This study followed the standards of the Declaration of Helsinki (revised version, Somerset West (SA), 1996 [
Patients were recruited from the regular patients of a general medicine practice in Berlin, Germany, run by a Chinese-born medical doctor trained in western and Chinese medicine. The MD usually provides both conventional care and acupuncture to her patients. The acupuncture is usually individualized based on the Chinese medicine syndrome diagnosis. Patients with chronic low back pain suitable for acupuncture therapy (which is reimbursed by the German health insurances) were invited to participate in the study. No additional allowance was paid for the study. Participants were informed about the study using the following descriptions for both interventions: one group receives acupuncture according to individually selected points on the basis of diagnostics of Chinese medicine and the other group receives acupuncture consisting of acupuncture points that have shown their effectiveness in several studies.
The randomization sequence was generated by a data manager, who was not involved in the analysis of the data and enrolment of the patients, with Microsoft Office Excel 2003 in a 1 : 1 ratio stratified for gender. The list was integrated into a secured database (Microsoft Office Access 2003) and was not accessible to the other staff members or the study physician. Randomization took place in the practice using the secured database. The patient’s allocation to the different treatment groups and the patient identification number for each single patient were assigned and accessible for the enrolling physician after patient data such as name and date of birth was entered and saved in the secured database. With that approach, the randomization list was hidden in the database and not accessible for anyone participating in the enrolment.
Patients were eligible for the trial if they fulfilled the following inclusion criteria: age of at least 18 years, male or female, low back pain for at least 3 months (clinical diagnosis of chronic low back pain confirmed by a medical specialist) and indication for treatment of low back pain with acupuncture confirmed by a medical specialist, average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0–100 mm), intellectual and physical ability to participate in the study, and informed consent.
Main exclusion criteria were acupuncture during the last 6 months, start of a new therapy for low back pain within the last 4 weeks, pregnancy, substance or drug abuse, and participation in another clinical trial.
All patients received Chinese medicine diagnostics including examination of pulse and tongue to avoid a bias due to a possible placebo effect caused by this kind of examination. Both acupuncture interventions were applied by the same medical doctor specialized in western general medicine (25 years of clinical practice) and trained in Chinese medicine with 20 years’ experience in treating low back pain with acupuncture. According to the current statutory health insurance benefit catalogue, 10 to 15 treatment sessions per year are usually reimbursed. In our study, two treatment sessions per week had to be applied, with a maximum number of 10 to 15 sessions depending on the patient’s individual needs. The standardized acupuncture was based on the acupuncture intervention from a large multicenter trial previously performed by our group [
Because it was a trial in a real-life setting, comedication was allowed in both groups, and their intake was documented using diaries.
The primary outcome measure was the area under the curve (AUC) summarizing the average low back pain intensity over eight weeks. For this, the back pain intensity of the last 24 hours was rated daily in a diary using a visual analogue scale [
Secondary outcome measures included the VAS for pain during the previous 7 days at eight and 26 weeks and the following outcomes at eight and 26 weeks: back function (Hannover Functional Ability Questionnaire, HFAQ; in German, Funktionsfragebogen Hannover Rücken) [
To assess the patients’ and doctor’s expectation for improvement due to the treatment before randomization, patients and doctors had to document their expectation of the therapy on categorical scales: “recovery,” “distinct improvement,” “slight improvement,” and “no improvement” as well as their assessment of the presumed therapy’s effectiveness: “very effective,” “effective,” “small effect,” and “no effect.”
The study was designed to detect a clinically relevant effect (standard mean difference of 0.5) for the primary outcome measure with a power of 80% and a significance level of 5% using a two-sided
The primary outcome (daily low back pain intensity summed over 8 weeks) was evaluated using analysis of covariance (ANCOVA) including treatment group, with baseline value and participants’ initial expectation from treatment as covariates. This resulted in adjusted mean severity scores per treatment group, 95% confidence intervals and
From 163 possible participants screened, 150 were enrolled between January 2009 and January 2011 (Figure
Baseline demographic and clinical characteristics of trial groups.
Characteristics | Standardized acupuncture |
Individualized acupuncture |
---|---|---|
Age (years; mean ± sd) | 59.3 ± 12.0 | 56.1 ± 12.9 |
Gender ( |
||
Female | 42 (53.8) | 45 (62.5) |
Male | 36 (46.2) | 27 (37.5) |
BMI (kg/m²; mean ± sd) | 27.2 ± 4.6 | 27.0 ± 5.0 |
>10 years of school ( |
10 (12.8) | 24 (33.3) |
Size of household ( |
||
Single person | 22 (28.2) | 16 (22.2) |
Multiperson | 55 (70.5) | 56 (77.7) |
Average low back pain during the previous 7 days (VAS |
60.7 ± 12.0 | 56.2 ± 10.0 |
Duration of low back pain (years; mean ± sd) | 16.8 ± 12.8 | 14.9 ± 11.8 |
Concomitant diseases ( |
||
Diseases of the nervous system | 0 (0) | 2 (2.7) |
Endocrine, nutritional, and metabolic diseases | 1 (1.2) | 3 (4.1) |
Diseases of musculoskeletal system | 12 (15.3) | 4 (5.5) |
Sick leave days of previous 8 weeks (days; mean ± sd) | 8.9 ± 14.8 | 8.2 ± 13.5 |
Prior consultation because of low back pain ( |
78 (100) | 69 (95.8) |
Low back pain/disability (HFAQ#; mean ± sd) | 36.0 ± 19.1 | 37.4 ± 20.4 |
SF-36 quality of life (SF-36#; mean ± sd) | ||
Physical health | 34.7 ± 7.7 | 35.7 ± 9.3 |
Mental health | 49.7 ± 11.1 | 46.2 ± 12.5 |
Experiences with acupuncture ( |
60 (76.9) | 56 (77.7) |
Expected effectiveness of acupuncture ( |
||
Very effective | 32 (41.0) | 24 (33.3) |
Effective | 41 (52.5) | 48 (66.6) |
Less effective | 4 (5.1) | 0 (0) |
Ineffective | 0 (0) | 0 (0) |
Preference ( |
||
Standardized acupuncture | 30 (38.4) | 35 (48.6) |
Individualized acupuncture | 46 (58.9) | 37 (51.3) |
BMI: body mass index; VAS: visual analogue scale for assessing the average low back pain intensity; HFAQ: Hannover Functional Ability Questionnaire; SF-36: 36-item quality-of-life questionnaire.
#Higher values indicate better status.
$Missing answers add to 100%.
Recruitment, treatment, and follow-up of patients with chronic low back pain.
The mean number of treatments was
Both groups showed a clinically meaningful improvement [
Primary and secondary outcomes at 8 and 26 weeks (adjusted for baseline value and participant’s expectation)*.
Standardized acupuncture mean (95% CI) | Individualized acupuncture mean (95% CI) | Differences individualized versus standardized acupuncture (95% CI) |
|
|
---|---|---|---|---|
Overall low back pain—area under the curve** |
1,482.9 |
1,768.7 |
285.8 |
0.080 |
Mean overall low back pain: (mean daily VAS |
26.5 (21.0; 31.9) | 31.6 (26.1; 37.1) | 5.1 (−0.6; 10.8) | 0.080 |
Days with pain medication: weeks 1 to 8µ | 4.9 (0.4; 9.3) | 5.6 (1.2; 10.0) | 0.7 (−3.9; 5.4) | 0.752 |
Days with physiotherapy: weeks 1 to 8µ | 2.1 (0.1; 4.0) | 1.9 (0.01; 3.8) | −0.2 (−2.2; 1.8) | 0.867 |
Number of acupuncture therapy sessions | 9.8 (8.4; 11.2) | 10.3 (8.9; 11.7) | 0.5 (−0.3; 1.3) | 0.226 |
Duration of therapy (minutes per week) | 41.1 (30.7; 51.5) | 44.4 (34.4; 54.4) | 3.3 (−2.6; 9.3) | 0.272 |
Average low back pain during the previous 7 days (VAS |
||||
8 weeks | 27.4 (21.2; 33.7) | 28.7 (23.4; 34.0) | 1.3 (−5.8; 8.4) | 0.723 |
26 weeks | 27.3 (21.0; 33.7) | 30.5 (24.6; 36.3) | 3.1 (−4.5; 10.8) | 0.424 |
Low back pain/disability (HFAQ#) | ||||
8 weeks | 25.8 (21.9; 29.6) | 27.5 (22.8; 32.1) | 1.7 (−3.4; 6.8) | 0.513 |
26 weeks | 24.3 (20.4; 28.3) | 25.9 (21.0; 30.8) | 1.5 (−3.7; 6.8) | 0.569 |
SF-36 quality of life (SF-36#) | ||||
Physical health at 8 weeks | 42.7 (40.3; 45.1) | 42.1 (40.1; 44.1) | −0.5 (−3.5; 2.4) | 0.714 |
Physical health at 26 weeks | 43.1 (40.7; 45.5) | 41.7 (39.5; 43.8) | −1.5 (−4.5; 1.6) | 0.343 |
Mental health at 8 weeks | 49.5 (47.0; 52.1) | 50.0 (47.4; 52.6) | 0.4 (−2.7; 3.6) | 0.788 |
Mental health at 26 weeks | 48.8 (46.1; 51.6) | 50.7 (47.9; 53.5) | 1.9 (−1.6; 5.4) | 0.287 |
Sick leave days | ||||
8 weeks | 4.8 (1.8; 7.8) | 4.5 (1.5; 7.4) | −0.3 (−3.4; 2.8) | 0.843 |
26 weeks (previous 4 months) | 9.0 (3.6; 14.4) | 9.7 (4.1; 15.2) | 0.6 (−4.8; 6.0) | 0.817 |
VAS: visual analogue scale for assessing the average low back pain intensity; HFAQ: Hannover Functional Ability Questionnaire; SF-36: 36-item quality-of-life questionnaire.
*The area under the curve was evaluated using analysis of covariance (ANCOVA) including treatment group, with baseline value and participants’ initial expectation from treatment as covariates. Secondary outcome parameters were analysed by similar ANCOVA or generalized estimating equation (GEE) models in a similar fashion.
µBased on daily data from a diary.
#Higher values indicate better status.
**The area under the curve (AUC) represents the sum of daily VAS scores (0–100) over 8 weeks.
Mean symptom severity VAS of daily data over 8 weeks, nonadjusted data. Dashed lines represent the borders of the area under the curve.
Secondary outcomes showed consistent results. The average pain severity after 8 weeks and 26 weeks did not differ significantly between both groups (Table
Mean (with 95% confidence interval) pain intensity over the last 7 days (VAS) at week 8 and at week 26, nonadjusted data. At baseline, VAS was different between both groups (0.014), but not for the latter time points.
Of the 150 patients in both intervention groups, none reported acupuncture-related side effects. However, adverse events reported by the patients included breast cancer, herpes zoster, and common cold (individualized group: 7 events, standardized group: 8 events), but none had a causal relation to the acupuncture treatment.
After the end of treatment, patients were asked to guess what treatment intervention had been administered to them. In the standardized group, 78.1% guessed they were in the standardized group while, in the individualized group, 55.7% guessed they were in the individualized group (Table
Guesses of group allocation.
Patients’ guesses | Group assignment | |
---|---|---|
Standardized | Individualized | |
Standardized | 57 (78.1%) | 39 (55.7%) |
Individualized | 16 (21.9%) | 31 (44.3%) |
In our study, we could not show a statistically significant difference between standardized and individualized acupuncture in the treatment of chronic low back pain. Results were consistent over all outcomes.
The main strengths of this trial are the randomized single-blinded study design, the relatively large sample size for a single-center trial on CAM, and the high compliance and follow-up rates. We aimed to answer a research question that has relevance for usual care practice. Therefore, the chosen setting in a general medical practice reflects a real-world setting. This routine care setting is a reason for the broad inclusion and exclusion criteria in our trial and the decision to leave the decision on the number of visits to the physician. The physician who performed the acupuncture usually treats her patients with individualized acupuncture. However, to evaluate the quality of care in her practice, she was highly motivated to compare it with a standardized acupuncture approach, which was comprised of those acupuncture points that were most frequently used by the participating physicians in a large randomized multicenter trial of acupuncture in patients with low back pain [
The outcome measure VAS is a validated and sensitive tool, which is widely used to measure pain. By using the area under the curve summarizing the VAS of week 1 to week 8 as our primary outcome, we were able to include different time points into one primary outcome measure. However, this might have caused an underestimation of the treatment effect, because the measure averages the pain intensity of the whole treatment course. Using only week 5 to week 8 data would have been another option; however, secondary outcomes such as the pain measured after eight weeks and after 26 weeks showed also no significant differences between groups. The secondary outcome measures we included in our study such as medication intake, back function, and quality of life also confirmed the results.
We tested sustained blinding in both treatment groups. The standardized group guessed the right treatment more often than one could expect by chance. One reason might be that more than half of the study patients were experienced with acupuncture. We do not think that this affected our results because both groups were informed to get an effective treatment and improved similarly. Furthermore, assessing blinding is a controversial discussion and was deleted from the current version of the CONSORT checklist [
The aim of this study was not to assess the efficacy of acupuncture for chronic low back pain. Berman et al. discussed its clinical relevance, [
Another option for a research question would have been noninferiority trial to evaluate whether standardized acupuncture for chronic low back pain is noninferior to individualized acupuncture. However, we decided to follow a superiority hypothesis, because individualized acupuncture requires more time resources, both from a training and application perspective. A multicenter trial would have produced more generalizable results and reduced possible bias of the participating physicians regarding their favored therapy.
Our study results suggest that there is no relevant difference in the outcome of standardized and individualized acupuncture in the treatment of chronic low back pain. For week 1 to week 8, one could even observe a trend toward superiority of the standardized acupuncture. However, this lack of statistical significance has to be interpreted with caution. Because of our statistical superiority approach, our study does not prove that standardized acupuncture is non inferior or equivalent to individualized acupuncture.
Our study might be compared with a study conducted in the United States that directly compared individualized acupuncture with standardized acupuncture [
In conclusion, in this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic low back pain. If a fixed set of points can be well established for a specific condition, this might have wide implications. Without the necessity for a diagnosis according to Chinese medicine, it might reduce time and knowledge necessary for the treatment. These can extend the availability of acupuncture toward conventional care. A next step multicenter noninferiority study to investigate whether standardized acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting and is more cost-effective could have clinical and health policy implications.
Claudia M. Witt, Daniel Pach, and Benno Brinkhaus conceived and designed the experiments. Claudia M. Witt, Daniel Pach, and Xiaoli Yang-Strobel performed the trial. Claudia M. Witt, Daniel Pach, Katja Icke, Rainer Lüdtke, and Stephanie Roll analyzed and discussed the data. Daniel Pach wrote the first draft of the paper. BennoBrinkhaus, Claudia M. Witt, Daniel Pach, Katja Icke, Rainer Lüdtke, Stephanie Roll, and Xiaoli Yang-Strobel revised the paper and approved the final version.
Daniel Pach and Claudia Witt had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
The authors thank Beatrice Eden for monitoring the study, Sonia El Amri for data acquisition, and all patients for their participation in this study. This study was funded within the grant for the chair of complementary medicine research of the Carstens Foundation.