Complementary Therapies in Clinical Practice 43 (2021) 101340

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Complementary Therapies in Clinical Practice

journal homepage: http://www.elsevier.com/locate/ctcp

A randomised controlled trial of laser acupuncture improves early

outcomes of osteoarthritis patients’ physical functional ability after total
knee replacement
Chiung-Hui Huang a, Mei-Ling Yeh b, 1, *, Fang-Pey Chen c, 1, **, Matthew Kuo d
a
Integration of Traditional Chinese Medicine with Western Nursing, National Taipei University of Nursing and Health Sciences, Nurse, Department of Nursing, Taipei
Veterans General Hospital, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan
b
Department of Nursing, National Taipei University of Nursing and Health Sciences, 365, Minte Rd., Taipei City, 11219, Taiwan
c
Center for Traditional Medicine, Taipei Veterans General Hospital and Adjunct Professor, National Taipei University of Nursing and Health Sciences, 201, Sec. 2, Shipai
Rd., Taipei City, 11217, Taiwan
d
Department of Nursing, National Taipei University of Nursing and Health Sciences, Student, Taipei American School, 800, Sec. 6, Zhongshan N. Rd., Taipei City,
11152, Taiwan

A R T I C L E I N F O A B S T R A C T

Keywords: Background and purpose: Total knee replacement is the most effective intervention for late-stage osteoarthritis;
Acupuncture however, a major concern is postoperative recovery of physical function. This randomised controlled trial
Joint stiffness evaluated the effects of acupuncture with low-level laser therapy (ALLLT) on early outcomes of physical function
Joint flexion
after total knee replacement.
Low level laser therapy (LLLT)
Physical functional ability
Materials and methods: Eighty-two osteoarthritis patients were recruited and randomly assigned to the experi­
Total knee replacement (TKR) mental group receiving ALLLT or the control group receiving sham ALLLT without laser beam output. Physical
function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee
replacement.
Results: Generalised estimating equations revealed a significant difference between the two groups in joint
flexion. The experimental group displayed better joint flexion and less stiffness on days 2 and 3 than did the
control group.
Conclusion: ALLLT can facilitate the recovery of physical function, as evidenced by knee joint flexion and stiff­
ness, in patients receiving total knee replacement.

1. Introduction consequently, management of joint stiffness and improvement of func­

People over 65 years of age comprise 14.05% of the total population
in Taiwan; this population is estimated to reach beyond 20% by 2026,
representing a notable increase in the number of elderly people [1]. The
prevalence of osteoarthritis in Taiwan is 15% of the total population [2]
and tends to increase with age. Total knee replacement (TKR) is the most
effective intervention for late-stage osteoarthritis. In 2030, the number
of patients undergoing their first TKR is estimated to increase by 546%
[3]. However, patients may refuse to become ambulatory post­
operatively because of restricted physical functioning and pain;
tional ability are crucial [4]. These patients must undergo treatment to
recover the physical function of the operated-on knee.
A systematic review concluded that acupuncture can effectively
alleviate pain on the first postoperative day and reduce the consumption
of analgesics [5]. Acupuncture can relieve pain from osteoarthritis by
increasing β-endorphin levels and reducing neurotransmission of sub­
stance P [6]. In traditional Chinese medicine, acupuncture is commonly
used in pain management because it distributes Qi (body energy) and
blood and harmonises yin and yang [7]. Acupuncture-related techniques
involve needle acupuncture, electroacupuncture, transcutaneous

* Corresponding author. Department of Nursing, National Taipei University of Nursing and Health Sciences, 365, Minte Rd., Taipei City, 11219, Taiwan.
** Corresponding author. Department of Traditional Medicine, Taipei Veterans General Hospital, 201, Section 2, Shi-Pai Rd., Taipei, 11219, Taiwan.
E-mail addresses: chhuang10@vghtpe.gov.tw (C.-H. Huang), meiling@ntunhs.edu.tw (M.-L. Yeh), fpchen@vghtpe.gov.tw (F.-P. Chen), 22matthewk@students.
tas.tw (M. Kuo).
1
Remark: Mei-Ling Yeh and Fang-Pey Chen equally contributed to this work as Correspondence authors.

https://doi.org/10.1016/j.ctcp.2021.101340
Received 26 May 2020; Received in revised form 20 February 2021; Accepted 21 February 2021
Available online 25 February 2021
1744-3881/© 2021 Elsevier Ltd. All rights reserved.
C.-H. Huang et al.
electrical nerve stimulation, laser acupuncture, and acupressure [8,9].
Of these, low-level laser therapy (LLLT) is administered based on the
biostimulation theory; it entails using a low-power laser beam that is
direct, focused, and expanded onto the surface of an acupuncture point
to improve blood circulation, relieve pain, and reduce inflammation as
well as swelling [10]. Studies have confirmed its effectiveness in the
recovery of physical function [11,12]. However, another systematic
review revealed that acupuncture may cause the side effects of fever,
pain, dizziness, thirst, dry mouth, and dry skin–induced desquamation
and itching [13]. Compared with needle acupuncture, LLLT is an easy,
noninvasive, safe, and pain-free procedure [14,15]. Acupuncture with
low-level laser therapy (ALLLT) may be capable of releasing endorphins
from the pituitary gland to relieve pain and thus facilitate functional
recovery. Therefore, this study evaluated the effects of ALLLT on phys­
ical function outcomes in patients undergoing TKR.
2. Materials and methods
2.1. Study design and participants
This was a randomised controlled trial with three repeated mea­
surements. The experimental group (n = 39) received ALLLT at the
Neiguan, Sanyinjiao, Taixi, Kunlun, Fengshi, and Futu acupuncture points,
whereas the control group (n = 40) received sham ALLLT at the same
acupuncture points. Participants were enrolled from an orthopaedic
ward of a medical centre in northern Taiwan. Inclusion criteria were
patients aged ≥60 years, diagnosed with knee osteoarthritis and who
had undergone TKR, subjected to spinal anaesthesia for unilateral knee
arthroplasty, and treated with intravenous patient-controlled analgesia
(IVPCA) and peripheral nerve block postoperatively. Patients taking
immunosuppressive agents; receiving intra-articular steroid treatment;
displaying opiate dependence; or with a history of light sensitivity, ep­
ilepsy, clinically significant cardiovascular diseases, cancer, and sys­
temic lupus erythematosus were excluded from this study.
Fig. 1. The flow diagram of research design and participant allocation.
2
Complementary Therapies in Clinical Practice 43 (2021) 101340
Fig. 1 shows the research design and participants. The estimation of
sample size was made using G-Power 3.1 software. According to the
primary outcome of joint flexion set using the parameters of effect size f
= 0.25, α error probability = 0.05, power = 0.80, and number of mea­
sures = 3, the study required not fewer than 74 participants. A research
team performed a randomisation process by using a randomised allo­
cation software to assign each recruited patient a serial number and
grouping status (experimental or control), and the information was
sealed in an envelope. After informed consent was obtained from each
participant and baseline data were collected, the envelope was opened,
and participants were assigned to their respective groups by one
researcher. All participants were blinded to their allocation and
intervention.
2.2. Intervention
All participants received IVPCA after TKR surgery. They received a
bolus of 1 mg morphine at 5-min lockout intervals for 4 h and were
prevented from exceeding a maximum dose of 10 mg. The experimental
participants then received ALLLT. The remote acupuncture points cho­
sen included Neiguan, Sanyinjiao, Taixi, Kunlun, Fengshi, and Futu [7,
16–18], as shown in Fig. 2. The study used the TRANS Laser Photo­
therapy device (Type: TI-816-3E2, DOH Medical Device Manufacturing
No. 003912) that adopted a GaAlAs laser diode as the medium. Ac­
cording to the guidelines for LLLT practice, the clinical reference for
joints therapy is defined as 3–8 J per acupuncture point [19,20]. Each
acupuncture point was given a 3-J stimulation, which was sustained for
10 s with a wavelength of 808 ± 10 nM and power density of ≤300 mW.
The control group participants received sham ALLLT at the same
acupuncture points without using the laser beam. All participants were
blind to the groups.
Participants were in a supine position when the acupuncture points
were chosen and cleaned using an alcohol swab. The device must be in
normal status before being operated. Both the researcher and
C.-H. Huang et al.
Fig. 2. The acupuncture points for physical functional ability.
participants were required to wear goggles to protect their eyes from
radiation damage during ALLLT. True or sham ALLLT was given at
Neiguan on both hands and at Sanyinjiao, Taixi, Kunlun, Fengshi, and Futu
of the diseased side. Intervention was stopped immediately if rube­
faction or discomfort occurred. The interventions were performed six
times at the second hour, sixth hour, 10th hour, day 1, day 2, and day 3
postoperatively. The interventions were given by the researcher who
graduated from a Chinese medical nursing institute and had completed
the training practice on ALLLT.
2.3. Measurement instruments
Data were collected before surgery—the baseline—and on day 1, day
2, and day 3 after surgery to assess physical function in terms of knee
joint flexion and stiffness. All participants were measured by the same
researcher. The angular magnitude of active flexion of the knee joint was
determined. Goniometry is widely used in orthopaedic practice and is as
precise as radiographic measurements, with an intraclass correlation
coefficient of 0.99 [21]. The participants were in a supine position for
the evaluation of the angular magnitude of active flexion of the knee
joint. The angle of the knee is 0◦ when the leg is straight. The pivot of the
goniometer is placed on the lateral epicondyle of the femur; a larger
angle indicates greater joint flexion.
Joint stiffness was assessed using the subscale of joint stiffness in the
knee joint with reference to the Western Ontario and McMaster Uni­
versities Osteoarthritis Index (WOMAC) [22]. This subscale is scored in
the range of 0–4, where 0 = no limitation, 1 = mild limitation, 2 =
moderate limitation, 3 = severe limitation, and 4 = complete limitation.
The internal consistency and reliability of the WOMAC for joint stiffness
had the Cronbach’s alphas of 0.70 in the original study [22] and 0.90 in
this study. In addition, demographic and clinical information were
collected, including age, sex, education, marital status, surgical site,
American Society of Anesthesiologists classification for status of medical
comorbidities before surgery, knee pain score, and IVPCA morphine
dose.
2.4. Data analysis
Statistical analysis was performed using IBM SPSS version 20.0 for
3
Complementary Therapies in Clinical Practice 43 (2021) 101340
Windows (SPSS Inc., Chicago, IL, USA). Descriptive statistics were used
to analyse demographic and clinical data. Furthermore, to verify ho­
mogeneity between groups, a Chi-square test was used for categorical
data, whereas the independent t-test was used for continuous data.
Generalised estimating equations (GEE) with the robust estimator of the
covariance matrix and exchangeable working correlation matrix were
used to test the effects of repeated measurements of joint flexion and
joint stiffness. Pain is the most common factor affecting the physical
function of the knee after TKR [23]. Therefore, this study adjusted the
variation in knee pain score and IVPCA morphine dose. For a selected
model, the best correlation structure was the one with the lowest value
of quasilikelihood estimation [24]. A P-value less than 0.05 was
considered significant.
2.5. Ethical considerations
Ethical approval was obtained from the Institutional Review Board of
Taipei Veterans General hospital (IRB No. 2018-02-007BCF). Informed
consent was obtained from all participants after they individually
received the explanation of the study. They were aware that all data
would be kept confidential at all times and they were free to withdraw at
any time during the study without their medical care being affected. All
data collected were for academic research.
3. Results
As shown in Figs. 1 and 79 participants completed the study, and
three dropped out due to medical treatment cancellation (n = 1), sleep
disturbance (n = 1), and morphine-induced allergy (n = 1). The attrition
rate was thus 3.6%. The experimental and control groups comprised 39
(mean age: 73.10 ± 7.37 years) and 40 participants (mean age: 73.20 ±
8.28 years), respectively, with a predominance of women in both groups
(n = 26, 66.7%, and n = 25, 62.5%, in the experimental and control
groups, respectively). Table 1 presents the demographic and clinical
characteristics, showing no significant difference between the two
groups (P > 0.05). Table 2 presents data on patients’ physical function,
specifically knee joint flexion and stiffness across time in each group.
Furthermore, Table 3 presents the result of the GEE analysis demon­
strating that upon adjusting knee pain score and IVPCA morphine dose,
C.-H. Huang et al. Complementary Therapies in Clinical Practice 43 (2021) 101340

Table 1 Table 3
Homogeneity test of demographic and clinical characteristics at baseline. Results of generalised estimating equations model for joint flexion and joint
Variables Experimental group Control group P-
stiffness.
(n = 39) (n = 40) value Parameters Estimate SE 95% CI χ2 P-value
a
Age (mean ± SD) 73.10 ± 7.37 73.20 ± 8.28 0.956 Joint flexionc

Sex (n, %) 0.699b Intercept 76.61 1.59 73.50–79.71 2337.64 <0.001

Male 13 (33.3) 15 (37.5) Experimental 5.06 2.51 0.14–9.98 4.07 0.044
Female 26 (66.7) 25 (62.5) groupa
Education (n, %) 0.315b Experimental group 12.84 1.03 10.82–14.86 155.67 <0.001
Elementary and below 19 (48.7) 13 (32.5) x day 2b
Junior high school 4 (10.3) 9 (22.5) Experimental group 21.72 1.86 18.07–25.36 136.46 <0.001
Senior high school 9 (23.1) 12 (30.0) x day 3b
College and above 7 (17.9) 6 (15.0) Joint stiffnessc
Marital status (n, %) 0.943b Intercept 3.79 0.25 3.30–4.28 227.35 <0.001
Never married 3 (7.7) 3 (7.5) Experimental − 0.44 0.33 − 1.10–0.21 1.78 0.182
Married 19 (48.7) 21 (52.5) groupa
Divorced/Widowed 17 (43.6) 16 (40.0) Experimental group − 1.60 0.14 − 1.88~ 123.81 <0.001
Surgical site 0.092b x day 2b − 1.32
Right knee 22 (56.4) 15 (37.5) Experimental group − 2.73 0.25 − 3.22~ 120.21 <0.001
Left knee 17 (43.6) 25 (62.5) x day 3b − 2.24
b
American Society of Anesthesiologists classification for status of medical 0.944
comorbidities (n, %) CI, confidence interval; SE, standard error.
a
I - II 28 (71.8) 29 (72.5) Control group.
b
III 11 (28.2) 11 (27.5) control group x day 1.
Knee pain score (mean ± 5.62 ± 2.12 6.53 ± 2.04 0.056a c
Adjusted pain score and morphine dose. Reference group.
SD)
IVPCA morphine dose 30.65 ± 9.09 43.33 ± 12.55 0.075a
(mean ± SD) At present, continuous passive motion or conventional physio­
a
therapy does not contribute to improving knee flexion for patients
An independent t-test for comparison in groups.
b receiving TKR [27,28]. This is possibly because these rehabilitation
A Chi-square test for comparison in groups. SD, standard deviation; IVPCA,
regimens cannot be provided immediately after surgery. However, a
intravenous patient-controlled analgesia. American Society of Anesthesiologists
classification for status of medical comorbidities, I: a normal healthy patient; II: study revealed that rehabilitation started within 24 h after TKR, rather
a patient with a mild systemic disease; III: a patient with severe systemic disease. than delayed to after 48 h, can improve knee joint flexion [29]. After
TKR, patients tend to move their knee joints at a limited angle to avoid
pain [30]. Studies have indicated that ALLLT combined with
Table 2 quadriceps-strengthening exercise is effective not only in improving
Descriptive results of early outcomes in physical functional ability. joint function but also in reducing knee pain among patients with
Variables Experimental group (n = 39) (mean Control group (n = 40) (mean osteoarthritis [31,32]. However, a study revealed that stimulating
± SD) ± SD) acupuncture points with pressure effectively improves postoperative
Knee joint flexion pain but not range of motion after TKR [33]. In this study, ALLLT
Baseline 101.41 ± 9.66 101.0 ± 9.21 contributed to prompt rehabilitation and improved the patients’ knee
Day 1 78.08 ± 9.78 75.5 ± 6.78 flexion while controlling the influence of pain.
Day 2 90.38 ± 6.82 89.38 ± 7.61 This study indicated that compared with the control group, the
Day 3 99.10 ± 7.51 97.25 ± 6.40
Knee joint stiffness
ALLLT participants also displayed more improvement in knee joint
Baseline 4.05 ± 1.84 4.13 ± 1.81 stiffness during the intervention period as well as simultaneous miti­
Day 1 3.59 ± 1.07 4.03 ± 1.07 gation of knee pain, which affects the joint’s functional ability. Because
Day 2 2.08 ± 0.81 2.80 ± 0.85 of these effects, ALLLT participants were able to start rehabilitation
Day 3 1.03 ± 0.90 1.53 ± 0.85
treatment and ambulation as early as possible after TKR; knee joint
SD, standard deviation. stiffness exhibited an obvious improvement in the first 3 days after
surgery. This finding accords with other studies that have confirmed the
a significant difference was evident between the two groups in knee effect of ALLLT on recovery of physical function [11,12,31,32]. Theo­
flexion angle (P = 0.044) but not in the WOMAC joint stiffness score (P retically, low-intensity laser therapy stimulates acupuncture points that
= 0.182). The experimental group displayed significant improvements normally transport Qi, thereby improving blood circulation and har­
in the knee flexion angle and WOMAC joint stiffness score on days 2 and monising yin and yang [7,10].
3 (P < 0.001). No participants had any adverse reaction to ALLLT in this study. A
study reported side effects in 2.5% of participants who underwent LLLT
4. Discussion when its dose was >8 J at one time point, which might have produced a
cumulative effect leading to erythema, fatigue, and mild dizziness [19].
This study confirmed the early recovery effects of ALLLT adminis­ This study gave a 3-J stimulation to each acupuncture point at each time
tered at the Neiguan, Sanyinjiao, Taixi, Kunlun, Fengshi, and Futu point following the guidelines for LLLT practice [19,20]. Practically,
acupuncture points in improving joint function in terms of joint flexion ALLLT is performed by stimulating acupuncture points using a
and stiffness in patients with osteoarthritis undergoing TKR. To the best low-intensity laser beam and is thus a nonpharmacological, noninvasive,
knowledge of the authors, this was the first study to use ALLLT to painless, and highly safe treatment for improving knee joint function
improve patients’ joint function after TKR. The knee joint flexion angle after TKR. This may promote fast and excellent restoration of joint
in participants of the experimental group was superior to that of par­ function.
ticipants in the control group. Their knee flexion improved gradually; This study has some limitations. First, the participants were recruited
however, the improvement was the highest during the intervention from only one hospital; thus, the results may not be generalisable. Sec­
period. This finding accords with that of other studies, which have ond, this study addressed the short-term effects of ALLLT in the first 3
revealed that ALLLT [25] and electroacupuncture [26] improve knee postoperative days. However, improvement in the first 3 days does not
function in patients with osteoarthritis. necessarily guarantee superior physical function results later. Finally,

4
C.-H. Huang et al.
the type of artificial knee joint applied and skill of surgeons may affect
outcomes.
5. Conclusion
This randomised controlled trial demonstrated that ALLLT improves
outcomes of knee joint function in terms of joint flexion and stiffness
early in patients with osteoarthritis receiving TKR in the first three
postoperative days. ALLLT, as a noninvasive, painless, and highly safe
procedure, is a suggested regimen for clinical care of patients with
osteoarthritis receiving TKR to improve knee physical function. In the
future, studies should be conducted to evaluate long-term effects of
ALLLT in osteoarthritis patients receiving TKR. In addition, the partic­
ipation of more medical centres can enhance the value of this study’s
findings.
Funding
The authors received no financial support for the research, author­
ship, and publication of this article.
Credit authorship contribution statement
Chiung-Hui Huang: study design, literature review, data analysis,
intervention performance, and manuscript writing; Mei-Ling Yeh: study
design, project supervision, allocation, laser trainer, data analysis, and
manuscript writing; Fang-Pey Chen: study design, laser trainer, and
manuscript editing; Albert Yeh: data management and manuscript
writing; Matthew Kuo: data management and manuscript writing. All
authors have read and approved the final version of the manuscript.
Declaration of competing interest
The authors declared no potential conflicts of interest with respect to
the research, authorship, and publication of this article.
Appendix A. Supplementary data
Supplementary data to this article can be found online at https://doi.
org/10.1016/j.ctcp.2021.101340.
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