Acupuncture Plus Cupping Relieve Pain and Reduce the Consumption of Analgesics in Patients with Advanced Knee Osteoarthritis

Abstract

Objective:

Acupuncture is a nonpharmacological option described in the literature; however, its efficacy in the treatment of knee osteoarthritis (KOA) is still controversial. This randomized, sham-controlled trial evaluated before-and-after differences in pain relief visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index Pain Section (WOMAC-Pain) among advanced patients with KOA assigned to acupuncture, cupping, combined therapy, or sham controls.

Method:

A total of 120 patients waiting for total knee arthroplasty from the knee outpatient unit of the Institute of Orthopedics and Traumatology, “Hospital das Clínicas” of the University of São Paulo Medical School, were invited to participate in the project. Inclusion and exclusion criteria were applied, and those who accepted signed an informed consent form and were later randomly allocated (https://www.random.org) to the following groups: Group A—Sham Acupuncture + Sham Cupping; Group B—Sham Acupuncture + True Cupping; Group C—True Acupuncture + Sham Cupping; Group D—True Acupuncture + True Cupping. The VAS and WOMAC-Pain questionnaire were used to measure the intensity of pain, and the number of analgesics and/or anti-inflammatory drugs used during the research period was also recorded.

Results:

We found statistical differences in VAS and the amount of pain medication used by patients (p = 0.035). The post hoc test for VAS values revealed a statistically significant difference between groups A and C (p = 0.04) and between groups A and D (p = 0.001). No differences were found in WOMAC-Pain index (0.258).

Conclusion:

The combination of acupuncture with cupping therapy demonstrated pain improvement by VAS and decreased the amount of pain medication used by patients, suggesting a complementary yet significant role in preoperative management.

Keywords

acupuncture cupping therapy osteoarthritis knee arthralgia arthroplasty randomized controlled trial

INTRODUCTION

Osteoarthritis is the most prevalent chronic pain articular condition in the world.¹ It is degenerative and inflammatory and considered to be one of the top 10 most disabling diseases worldwide.^2,3 Its incidence is more prevalent among elderly people aged more than 50 years and can compromise quality of life, bringing direct and indirect great economic loss.⁴

Among all the joints that could develop osteoarthritis, knee is the most commonly affected.⁵ Normally, it can start with an insidious and progressive pain, and most of the time it also presents by articular stiffness and functional loss.^5–7

Facing this highly prevalent and functionally limiting chronic disease, which attacks mainly aged people and its pathophysiology has multiple involved factors (genetic, mechanical, inflammatory, endocrine, among others),^5,8 several articles propose a multidisciplinary approach for knee osteoarthritis (KOA), involving pharmacotherapy and nonpharmacological treatments in order to improve pain intensity and improve knee function.^9,10

Acupuncture is a nonpharmacological therapeutic option depicted in medical literature; however, its effectiveness in this condition is still controversial, especially in advanced stages.^11–15 This randomized, sham-controlled trial evaluated before-and-after differences in pain relief visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index Pain Section (WOMAC-Pain) among advanced patients with KOA assigned to acupuncture, cupping, combined therapy, or sham controls.

MATERIALS AND METHODS

A total of 120 patients with osteoarthritis waiting for total knee replacement (TKR) surgery from the Knee Outpatient Unit of The Institute of Orthopedics and Traumatology, “Hospital das Clínicas” of the University of São Paulo Medical School (IOT-HCFMUSP), were included in the study. Inclusion criteria were applied and who accepted signed the informed consent form and registered in https://clinicaltrials.gov (NCT 04168593). This protocol was approved by the Committee of Ethics in Research of HCFMUSP (1.828.227).

The included patients were allocated by block randomization (size 12) to the following groups: A.

Group A—Sham Acupuncture + Sham Cupping

Group B—Sham Acupuncture + True Cupping

Group C—True Acupuncture + Sham Cupping

Group D—True Acupuncture + True Cupping

Inclusion Criteria

Patients with a diagnosis of KOA who were waiting for TKR surgery and with more than or equal to 15 points on Pain Section of the Score of Western Ontario McMaster Osteoarthritis Index (WOMAC-Pain).

Exclusion Criteria

Advanced dementia of central origin (Parkinson’s, Alzheimer’s), diabetic peripheral neuropathy, stroke sequel, previous digestive bleeding background, chronic renal failure, cardiac failure, fibromyalgia, rheumatoid arthritis, systemic lupus, severe depression, psychiatric disorders, and concomitant hip arthritis.

VAS and WOMAC-Pain were applied to enrolled volunteers.¹⁶ Amounts of painkillers and nonsteroid anti-inflammatories taken by the volunteers were registered during the period of the study.

Treatment

Sham Acupuncture: Placement of placebo dagger-type needles (needle tip retracts when contact in the patient’s skin) on the following points: LI11, SP9, SP10, LR8, GB34, ST34, and Ex-LE5. Each acupuncture session lasts 20 mins.

Sham Cupping: After each session of acupuncture (either true or sham), four 4.5 cm diameter plastic cupping were placed on SP9, SP10, GB34, and ST34 regions, fixed by a micropore strip, without negative pressure or movement. Application time lasts 10 mins.

True Acupuncture: Needling on classical points LI11, SP9, SP10, LR8, GB34, ST34, and Ex-LE5 with “De Qi” sensation. Stainless steel, flexible, disposable, and sterile, 0.25 mm diameter for 40 mm length needles were used, after local asepsis with 70% ethanol by volume. Session time lasts 20 mins.

True Cupping: After each acupuncture session (either true or sham), the needles were removed, new asepsis with 70% ethanol by volume, then four plastic cuppings with 4.5 cm of diameter were placed on SP9, SP10, GB34, and ST34 regions, fixed by negative pressure after 2 pump actions (around −300 mm Hg) by 5 mins. After this 5-min period, the cuppings slide on the skin surface by longitudinal movements for another 5 mins with objective of releasing different soft-tissue planes around knees. A neutral gel (Carbogel ULT®) was used to ease cupping movements.

All steps of the treatment were performed by trained and qualified physicians who were Brazilian Medical Acupuncture College licensed professionals. There were 2 sessions of treatment per week, a total of 10 sessions per patient.

Information about the acupuncture rationale, details of needling, treatment regimen, practitioner background, and comparator are described in Table 1.

Table 1.

Checklist According to Standards for Reporting Interventions in Clinical Trials of Acupuncture¹⁷

1) Acupuncture rationale	1a) Style of acupuncture	Traditional Chinese Medicine
	1b) Reasoning	Remove Qi stagnation
	1c) Extent	Fixed acupoints
2) Details of needling	2a) Number of needle insertions per subject per session	16 needles
	2b) Points used bilaterally	LI11, SP9, SP10, LR8, ExLE5, GB34, ST34
	2c) Depth of insertion	3 cm
	2d) Response sought	De Qi
	2e) Needle stimulation	Manual
	2f) Needle retention time	20 mins
	2g) Needle type	0.25 × 40 mm, stainless steel
3) Treatment regimen	3a) Number of treatment sessions	10
3) Treatment regimen	3b) Frequency and duration of treatment sessions	Twice per week for 5 weeks, each session 30 mins (20 mins of MA and 10 mins of cupping)
4) Other components of treatment	4a) Details of other interventions	4 Plastic Cuppings with 4.5 cm of diameter
4) Other components of treatment	4b) Setting and context of treatment	Outpatients’ department
5) Practitioner background		Medical doctor, licensed acupuncturist, hospital employee, with >10 years of acupuncture practice
6) Control or comparator	6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice	Sham Acupuncture—Streitberger Device
6) Control or comparator	6b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used	Sham Cupping- cupping fixed with micropore without negative pressure around SP9, SP10, GB34, eST34

Sample Calculation

The Knee Outpatient Unit of The IOT-HCFMUSP recruited 167 patients between August 1, 2015 and January 31, 2016, with an indication for knee replacement, and who had fulfilled inclusion criteria and not been excluded by exclusion criteria for this study.

The WOMAC-Pain of this population ranged from 10 to 20 with a mean of 15.41 and a standard deviation of 2.81. However, following the WOMAC-Pain inclusion criterion Pain (≥15), the mean value is 16.917 and standard deviation is 1.558.

In possession of these data and taking into account the design of this clinical trial based on 2 evaluation measures (baseline and final), with an improvement of at least 12% in relation to the baseline (considered clinically relevant),¹⁸ the calculated population sample size was 22 patients in each group, with a power of 95% and an alpha of 5%, using one-way analysis of variance (ANOVA).

We chose to increase the sample size to 30 patients in each group, totaling 120 patients in this study.

Statistical Analysis

The evaluation of pain intensity was carried out by comparing the measures of the differences in the values between the initial and final WOMAC-Pain and the VAS. Data normality was assumed based on the Central Limit Theorem (n ≥ 30/group) and minimal discrepancy between mean and median values. Parametric tests (ANOVA + Tukey’s post hoc) were selected to enable standardized effect size calculation (Cohen’s d).

In assessing the amount of rescue pain medication used before and after treatment, we used the chi-square test.

We used the concept of Intent to Treat for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.

The above information is summarized in Table 2.

Table 2.

Methodology According to Standards for Reporting Interventions in Clinical Trials of Acupuncture¹⁷

Trial design (3ab)	Randomized controlled trial
Participants (4ab)	Patients from the wait list to total knee replacement
Interventions (5)	Group A—Sham Acupuncture + Sham Cupping
	Group B—Sham Acupuncture + True Cupping
	Group C—True Acupuncture + Sham Cupping
	Group D—True Acupuncture + True Cupping
Outcomes (6ab)	VASWOMACPain medication intake
Sample size (7ab)	Calculation of WOMAC-Pain mean and standard deviation from wait-list patients
Sequence generation (8ab)	www.randomization.com
Allocation concealment (9)	Opaque envelope
Implementation (10)	Consecutive blocks sampling
Blinding (11ab)	Streitberger needles; Sham cupping; blinded data collector and statistic staff
Statistical methods (12ab)	Intent to Treat (ITT)One-way ANOVA and Post Hoc Comparisons (Tukey’s Test)Chi-square test for the number of medications after and before

ANOVA, analysis of variance; VAS, visual analog scale; WOMAC-Pain, Western Ontario and McMaster Universities Osteoarthritis Index Pain Section.

RESULTS

We enrolled 28 male (23.3%) and 92 female (76.7%) volunteers, whose ages ranged from 43 to 90 years old, with an average of 66.8 years old. Among 120 participants, just 10 (8.3%) did not complete the study.

Treatment adherence varied by protocol, with Group D completing the highest mean number of sessions (8.8), followed by Group B (8.3), Group C (8.1), and Group A (7.1). The descriptive distribution of the profile of patients allocated to each group according to gender, age, dropouts, and number of sessions is shown in Table 3.

Table 3.

Distribution by Gender, Mean Age, Number of Dropouts, and Mean Number of Sessions Performed per Patient

Group	N	Female	Male	Mean age	Dropouts	Average of number of treatments received
A	30	21	9	66.1	4 (13.3%)	7.1
B	30	23	7	66.1	2 (6.7%)	8.3
C	30	23	7	68.1	3 (10%)	8.1
D	30	25	5	66.8	1 (3.3%)	8.8

There were no differences in WOMAC-Pain and VAS values among the groups at baseline.

The analysis of changes in WOMAC-Pain scores (baseline to final assessment) across all groups showed comparable reductions within group (Group A: 5.23 ± 3.89; B: 5.60 ± 4.05; C: 5.20 ± 4.22; D: 7.07 ± 4.34), but there are no statistically significant differences in mean improvements between groups (p = 0.258). Post hoc Tukey tests confirmed no significant pairwise differences between any group combinations (Table 4).

Table 4.

Presentation of Descriptive Data for Each Group Related to the Values of the Difference Between Initial and Final WOMAC-Pain (One-Way ANOVA, p = 0.258)

Variable	Group	N	Mean	SD	p	Cohen’s f
Dif_WOMAC_Pain	A	30	5.233	3.892
	B	30	5.600	4.048
	C	30	5.200	4.221
	D	30	7.067	4.339
	Total	120			0.258	0.187

N: number of participants; Mean: mean difference between baseline and final score; SD: standard deviation; p: level of significance; Cohen’s f: measure of effect size.

The analysis of differences in initial and final VAS scores revealed a significant overall effect (p = 0.001), with a medium effect size (Cohen’s f = 0.38) and high observed statistical power (Table 5). Group D showed the largest mean improvement (43.87 ± 30.1, 95% confidence interval or CI [33.10, 54.64]), followed by Group C (34.97 ± 26.76, 95% CI [25.39, 44.54]), Group B (28.00 ± 26.64, 95% CI [18.47, 37.53]), and Group A (16.60 ± 22.70, 95% CI [8.48, 24.72]), as showed in Figure 1. The comparison between Group A and Group C shows a mean difference of −18.367 and a p-value of 0.043, indicating a significant difference at the adjusted significance level. The effect size for this comparison is large (Cohen’s d = 0.81). Similarly, the comparison between Group A and D reveals a mean difference of −27.267 and a highly significant p-value (7.446 × 10^−4), with a large effect size (Cohen’s d = 1.01) (Table 6). The high power (≥80%) indicates adequate sensitivity to detect the observed effect size given the sample size.

Table 5.

Descriptive Data for Each Group Related to the Values of the Difference Between Initial and Final VAS and p-Value (One-Way ANOVA, p = 0.001)

Variable	Group	N	Mean	SD	SE	95% CI lower	95% CI upper	p	Cohen’s f
Dif_VAS	A	30	16.6	22.7	4.144	8.48	24.72
	B	30	28.000	26.641	4.864	18.47	37.53
	C	30	34.967	26.755	4.885	25.39	44.54
	D	30	43.87	30.1	5.496	33.10	54.64
Total		120						0.001	0.38

N: number of participantes; Mean: mean difference between baseline and final score; SD: standard deviation; SE, standard error; 95% CI, 95% confidence interval; p: level of significance; Cohen’s f: measure of effect size.

FIG. 1.

VAS difference means with 95% confidence intervals for groups A, B, C, and D between baseline and final score. VAS, visual analogue scale.

Table 6.

Post Hoc Comparisons Group (Tukey’s Test) Between Initial and Final VAS, p-Value, and Cohen’s d

Group	Group	Mean difference	t	p Tukey	Cohen’s d
A	B	−11.400	−1.655	0.352
	C	−18.367	−2.666	0.043	0.81
	D	−27.267	−3.958	7.446 × 10⁻⁴	1.01
B	C	6.967	1.011	0.743
	D	−15.867	−2.303	0.103
C	D	−8.900	−1.292	0.570

p Turkey: value adjusted for comparing a family of four; Cohen's d: size of the difference. The values in bold represent a significant p-value with a large effect size.

During the study, the name of the drug in use was noted, as well as its dosage, before-and-after the protocol. For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described in Table 7 as Y (yes), and those who maintained or even increased the amount or simply did not return such information, we described as N (no).

Table 7.

Description of the Number of Individuals According to the Amount of Medication at the End of the Study and Calculation of p by Chi-Square Test

	N	Y	p
			0.03493
A	18	12
B	12	18
C	11	19
D	7	23

Group A: Sham Acupuncture + Sham Cupping; Group B: Sham Acupuncture + True Cupping; Group C: True Acupuncture + Sham Cupping; Group D: True Acupuncture + True Cupping; N: no; Y: yes, to medication reduction.

N (No) = Kept the Quantity; Y (Yes) = Decreased the Amount.

After the completion of the study, the statistical analysis revealed that there was a significant difference in the decrease in the use of pain medications between groups A, B, C, and D.

Safety and Adverse Effects

All adverse effects in each session performed during the protocol execution period were computed.

In group A, 206 sessions were performed, and no complications were reported.

In group B, 248 sessions were performed, with the record of 6 episodes (2.42%) of hematomas located in the region performed with true suction.

In group C, 244 sessions were performed, with the recording of 13 episodes (5.33%) of hematomas located in a site punctured by true acupuncture.

In group D, 265 sessions were performed, with 13 episodes (4.91%) of bruising and 1 episode (0.38%) of presyncope.

Other complications, such as skin infections, arterial injury, and peripheral nerve injury, were not documented.

DISCUSSION

KOA is one of the most prevalent chronic pain joint diseases in the world population. There is no curative treatment for this disease, and all available measures aim to improve function and relieve pain. The treatment consists of pharmacological, nonpharmacological, and interventional pain procedures (such as viscosupplementation and radiofrequency). When the previous treatments fail, TKR is considered.⁵

The pathophysiology of KOA is complex and not fully elucidated. The current understanding is that it is an essentially low-grade inflammatory disease associated with risk factors, such as female gender, age, local trauma, genetics, obesity, and other metabolic diseases. For this reason, the main treatment is education, weight loss guidance, and low-impact physical activity, which are recommended by all guidelines.^10,19–23

The effectiveness of acupuncture is still controversial in the literature for KOA. There are guidelines that recommend its use, such as American College of Rheumatology,¹⁹ European Alliance of Associations for Rheumatology,¹⁰ and European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases,²² while others contraindicate it, such as Osteoarthritis Research Society International,²¹ American Academy of Orthopedic Surgeons,²⁰ and National Institute for Health and Care Excellence.²³

The treatment of chronic pain is also a big challenge, and a multimodal approach is advocated in the literature, especially when the neuropathic component is present.²⁴ The concept of multimodal analgesia emerged in the pharmacological environment that combines drugs with different mechanisms of action to produce additive or synergistic effects, allowing the use of smaller doses of each medication, and consequently reducing their adverse effects.²⁵

In this same strategy, in Traditional Chinese Medicine, there are methods that enhance acupuncture’s effect, such as cupping, moxibustion, electric stimulation (electroacupuncture), Chinese herbs, and manual manipulation (Tuina).³ The combination of acupuncture plus cupping has been described for several conditions; however, it is not yet established for KOA.

According to some studies, the classic static cupping relaxes muscles and improves the local microcirculation,^26,27 and when the cupping is moving longitudinally, respecting the paths of the meridians, it plays a very similar mechanism to myofascial release therapy,²⁸ which acupuncture does not act.

There are several mechanisms underlying acupuncture analgesia that involve since local area, where the needle is located, and central nervous system, promoting neuromodulation on the dorsal horn of the spinal cord and the activation of descending inhibition pain system, releasing substances such as opioid peptides, 5-hydroxytryptamine, and noradrenalin.^29,30

Considering the VAS index, this study showed significant improvement in group C, in which only acupuncture was the true intervention (p = 0.04). However, when acupuncture is combined with cupping the improvement was greater (p = 0.001; power = 88%). This suggests synergic effect that acupuncture modulates inflammatory pathways (e.g., reduction of interleukin-6 and tumor necrosis factor-α), while cupping promotes myofascial release and increased local blood flow. To our knowledge, this is the first sham-controlled randomized controlled trial to evaluate acupuncture-cupping synergy in patients with advanced KOA awaiting arthroplasty and supports the safety of acupuncture-cupping therapy.

The absence of differences in WOMAC-Pain reinforces that the intervention acts preferentially on pain intensity, without a significant impact on joint function in this population with irreversible structural injuries, which is not necessarily discreditable for acupuncture recommendation, since the analgesic effects are probably the final outcome that patients desire.

Regarding important risk factors of this disease, as age and obesity, these patients often use lots of medications to control their comorbidities, such as systemic arterial hypertension, diabetes, and hypercholesterolemia. In order to reduce polypharmacy and possible drug interactions, as well as their adverse effects, nonpharmacological measures such as acupuncture to control pain have been emphasized lastly.

In this context, it is very relevant that the reduction of consumption of pain medications by the participants. About 76% of the individuals who received the true combined treatment (group D) reduced the amount of consumption of drugs such as dipyrone, paracetamol, diclofenac, ibuprofen, ketorolac, codeine, tramadol, cyclobenzaprine, and carisoprodol, compared with 40% of the individuals in the control group (group A). In view of this finding, we believe that the combination of treatments was useful in reducing pain intensity, considering that such medications were taken as needed.

In patients awaiting arthroplasty, reducing pain and analgesic consumption (especially opioids) has practical implications: lower risk of side effects, perioperative complications, and associated costs. While waiting for the definitive treatment (total arthroplasty), the effective treatment for improving patients’ quality of life, thus functionality, is an effective pain relief treatment. In this context, acupuncture and cupping can play an important role, being part of a multimodal treatment for chronic pain; they can achieve an important result.³¹

LIMITATION

The limited follow-up (10 sessions) does not allow us to assess the benefits in the long term.

CONCLUSION

The therapeutic approach to patients with KOA should be multidisciplinary. Acupuncture alone or associated with cupping treatment twice a week for 5 weeks reduces pain intensity by VAS and decreases the use of pain medications in patients who are waiting for knee replacement, suggesting a complementary role in preoperative management.

AUTHORS’ CONTRIBUTIONS

A.W.W.T.: Conception/data collection/data analysis and interpretation/drafting the article/critical revision of the article/final approval of the version to be published. W.T.H., R.S.d.A., and C.A.L.: Conception/data analysis and interpretation/critical revision of the article/final approval of the version to be published. M.Y.H.U. and J.C.: Data collection/drafting the article/critical revision of the article/final approval of the version to be published. M.K.D.: Critical revision of the article/final approval of the version to be published.

Footnotes

ACKNOWLEDGMENTS

The authors would like to thank the hospital staff, especially Wanda Diney Valenti, Elizabeth de Araújo Silva, and Olga Fujiko Nagashima de Santana, who contacted all patients by telephone and prepared all materials to conduct this study.

AUTHOR DISCLOSURE STATEMENT

No competing financial interests exist.

FUNDING INFORMATION

No funding was received for this article.

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