INTEGRATIVE MEDICINE SECTION
Original Research Article
Laser Acupuncture Treatment Improves Pain
and Functional Status in Patients with
Subacromial Impingement Syndrome:
A Randomized, Double-Blind,
Sham-Controlled Study
Sibel Kibar, MD,* Hatice Ecem Konak, MD,* Deniz Evcik, MD,†and Saime Ay, MD*
*Department of Physical Medicine and Rehabilitation, Ufuk University School of Medicine, Ankara, Turkey; †
Department of Therapy and Rehabilitation, Ankara University Haymana Vocational School, Ankara, Turkey Correspondence to: Sibel Kibar, MD, Department of Physical Medicine and Rehabilitation, Ufuk
Universitesi, Fizik Tedavi ve Rehabilitasyon Ana Bilim Dalı, Mevlana Bulvarı No88 Balgat, 06530, C¸ankaya, Ankara, Turkey. Tel: 0090-505-688-87-24 or
0090-312-204-43-55; Fax: 0090-312-287-23-90; E-mail: sibelkbr@gmail.com.
Conflict of interest: There are no conflicts of interest to report.
Abstract
Objective. The present study aims to determine the effect of laser acupuncture in patients with subacro-mial impingement syndrome (SAIS).
Design. Randomized, double-blind, sham-controlled study.
Setting. Physical medicine and rehabilitation outpa-tient clinic.
Subjects. A total 73 patients with SAIS were ran-domly assigned into a treatment group (n 5 36) and a control group (n 5 37).
Methods. The treatment group received laser acu-puncture, and the control group received sham laser acupuncture. Eleven acupuncture points (GB
21, LI 4, LI 11, LI 14, LI 15, LI 16, SI 9, SI 10, SI 11, TE 14, and TE 15) were irradiated using a gallium-aluminium-arsenide continuous wave diode-laser, with a wavelength of 850 nm and a power output of 100 mV. The laser acupuncture treatment at each acupuncture point was administered at 4 joules/cm2 (total dose 5 40 joules). All patients were also treated with a hot pack. The patients were assessed at baseline and after 15 sessions of laser treatment. Pain severity and doctor’s and patient’s global as-sessments were measured via visual analog scale (VAS). Range of motion (ROM) and functional status were measured using a digital inclinometer and the Shoulder Pain Disability Index, respectively.
Results. Statistically significant improvements were observed in all parameters in the treatment group. All parameters of pain and functional status in the treatment group were significantly better than those in the control group at week 3.
Conclusions. To the best of our knowledge, this is the first study that investigates the effect of laser acupuncture in SAIS. The positive results of the present study should lead to further laser acupunc-ture studies with combinations of different acu-puncture points, at different wavelengths, and with long-term follow-up periods.
Key Words. Subacromial Impingement Syndrome; Shoulder Pain; Laser; Acupuncture
Introduction
Shoulder pain is commonly encountered in all adult age groups in clinical practice [1]. It has been reported that nearly 50% of the general population experiences at least one episode of shoulder pain attack annually and that the prevalence of shoulder problems is 30% [2]. The most
common shoulder pathology is subacromial impingement syndrome (SAIS) [3]. SAIS occurs due to mechanical dis-order in the subacromial space and is characterized by shoulder pain, restricted range of motion (ROM), and func-tional disability performing normal daily activities [4]. Subacromial impingement syndrome–induced cuff le-sions can exacerbate over time, and some complica-tions can develop, such as capsulitis and frozen shoulder [2]. Although SAIS is generally self-limiting, it often persists due to these complications. A long-term follow-up study that included 108 elderly patients with shoulder disorders reported that 74% of the patients had pain for more than three years [5]. A variety of treat-ment methods for shoulder disorders have been studied previously, and physiotherapy is reported to be a pri-mary method [6]; however, it was also reported that there is a need for more high-quality studies on physio-therapeutic interventions [6]. Some systematic reviews and randomized clinical trials indicate that low-intensity laser therapy (LILT) could be an effective treatment for relieving pain and reversing functional loss or disability in patients with SAIS [7,8]; however, other studies report that LILT is of no benefit to such patients [9].
A relatively new laser procedure is stimulation of acupunc-ture points using LILT [10]. The effect of laser acupuncture has been investigated based on functional magnetic reson-ance imaging studies. It was shown that the cerebral cortex is activated when certain acupuncture points are stimulated by needles or laser, but not during placebo laser treatment [11]. The excessive heterogeneity of laser application par-ameters in previous studies has prevented the establish-ment of clear suggestions concerning treatment parameters. A review of 18 laser acupuncture studies re-ported that only five of the studies were of high quality and that only two of the five high-quality studies used a suffi-cient LILT dose. Moreover, it was concluded that the opti-mal LILT thresholds and doses must be determined before laser acupuncture can be considered as an alternative to needle acupuncture [12].
Laser acupuncture treatment of musculoskeletal system problems has been studied before. In a recent adhesive capsulitis study with a two-year follow-up, LILT was ad-ministered to two acupuncture points and was reported to be effective [13]. To the best of our knowledge, no study has investigated the effect of laser acupuncture in patients with SAIS, for which acupuncture points can be used for treatment; nor has the optimal laser dose been investigated. As such, the present study aims to deter-mine the effect of laser acupuncture on pain and func-tional status in SAIS patients and to determine the optimal laser acupuncture treatment protocol for SAIS. Methods
Participants and Study Design
This randomized, double-blind, sham-controlled study was conducted at Ufuk University, School of Medicine,
Department of Physical Medicine and Rehabilitation, Ankara, Turkey. The study included 125 patients (age range ¼ 18–70 years) who had experienced shoulder pain for at least three months and had at least one score pain measurement of 4 cm or more on the visual analog scale (VAS) at rest, at night, or during physical activity [14]. All patients were evaluated by the same physiatrist between 2013 and 2014 in detail and under-went musculoskeletal and neurologic evaluations. Patients were diagnosed as SAIS via the Neer and Hawkins-Kennedy impingement tests [15,16] and were characterized as stage I or stage II SAIS based on MRI findings. Patients with stage III SAIS, complete tear of the rotator cuff, adhesive capsulitis, calcific tendinitis, acromioclavicular arthritis, any rheumatic disorder (such as rheumatoid arthritis or spondyloarthropathy), a history of acute shoulder trauma, any intra-articular injection, or physical therapy during the previous six months were excluded from the study. Other exclusion criteria were a history of shoulder surgery, history of malignancy, acute infection, any neurologic disorder, and pregnancy. In addition, patients with any cognitive deficit that could negatively affect the evaluation process were excluded. In all, 52 patents were excluded; the remaining 73 pa-tients were randomly assigned to the treatment group (group 1, N¼ 36) or the control group (group 2, N ¼ 37) by a researcher blinded to the treatment procedure using the patients’ file numbers. The randomization and allocation process is shown in Figure 1. Baseline and final evaluations were made by two independent re-searchers blinded to the two groups.
Treatment Procedures
The laser acupuncture treatment consisted of 15 ses-sions during a three-week period (five sesses-sions per week). The treatment group received laser acupuncture, and the control group received sham laser acupuncture. A hot pack was applied for 20 minutes following each treatment session in both groups. In addition, patients underwent exercise training, including pendulum exer-cises, posterior capsule stretching, and isometric shoul-der exercises (15 repetitions in all directions, three times daily for three weeks). Excessive physical activity was forbidden at the onset of the treatment.
A gallium-aluminium-arsenide (GaAlAs, infrared laser) continuous wave diode laser device (Chattanooga Group, Vista, California, USA) with a wavelength of 850 nm (invisible), a power output of 100 mV, and a spot area of 0.07 cm2 was used for laser acupuncture. In the treatment group, patients received laser for 40 se-conds at a dosage of 4 joules/cm2for each acupunc-ture point (total dose ¼ 44 joules per session for 11 points) in continuous mode, which was administered by the same physiotherapist.
The acupuncture points (GB 21, LI 4, LI 11, LI 14, LI 15, LI 16, SI 9, SI 10, SI 11, TE 14, and TE 15) were
determined according to the literature regarding acupuncture application in shoulder pain based on trad-itional Chinese acupuncture. The acupuncture points were also chosen in consultation with a neurologist, who is a licensed acupuncturist trained in traditional Chinese acupuncture with more than five years of clin-ical experience in Chinese acupuncture [17–,20]. The acupuncture points are demonstrated inFigure 2. Sham laser was administered in the control group as in the treatment group, but with the device turned off. All pa-tients and physiotherapists used protective eyeglasses during each treatment session.
Outcome Measures
The patients were assessed at the baseline (week 0) and after the 15th treatment session (week 3). Sociodemographic data were collected, including pa-tient age, gender, employment status, body mass index (BMI; body weight [kg]/height2 [cm2]), and related vari-ables. The severity of pain was measured at rest, during movement, and at night using a VAS that ranged from a score of 0 cm (absence of pain) to 10 cm (severe pain). Patient and doctor global assessments were also eval-uated via VAS. Functional status was measured using the Shoulder Pain and Disability Index (SPADI), a self-administered, shoulder-specific questionnaire with a pain subscale (five items) and disability subscale (eight items) that are rated using a 0 to 10 cm VAS. The
SPADI score ranges from 0 to 100; higher scores indi-cate a higher degree of disability [21]. The Turkish ver-sion of the SPADI was reported to be valid and reliable by Bumin et al. [22].
Shoulder ROM was measured using a digital inclinom-eter (Baseline Digital Inclinometer, EN-121057, Baseline Products, USA), which is considered a highly reliable and valid technique [23,24]. All landmarks described for placement of the digital level were con-sistent with anatomical position [23]. To measure ac-tive ROM for coronal abduction, patients acac-tively raised their arm in the coronal plane with the thumb pointed toward the ceiling. Once active end range was achieved, the examiner placed the digital inclinometer on the superior/distal arm proximal to the elbow [24]. To measure external rotation, each patient was placed in the supine position with hips and knees flexed at 45. The tested arm was supported on the table in 90 of abduction, with the elbow flexed to 90 and
with a rolled-up towel placed under the humerus. Each patient then actively brought their arm back into external rotation, and, once active end-range was achieved, the examiner placed the digital inclinometer on the distal forearm, just proximal to the wrist. To measure sagittal flexion, each patient raised their arm actively in the sagittal plane and the examiner placed the digital inclinometer on the superior/distal arm Figure 1 Randomization and allocation process.
proximal to the elbow once the arm reached the active end range [24].
The patients were told not to use nonsteroidal anti-inflammatory drugs (NSAIDs) or neuropathic pain drugs during the three-week treatment period. Paracetamol use was permitted in cases of intolerable pain (max-imum dose: 500 mg three times a day). All the patients provided written informed consent after receiving a de-tailed information sheet describing the study protocol. The study protocol was approved by the Ufuk University School of Medicine Research Ethics Committee (Registration No. 030420136) and was conducted in ac-cordance with the Declaration of Helsinki.
Statistical Analysis
Power analysis was conducted to estimate the requisite sample size. No similar studies had previously estimated the possible magnitude effect. A clinically significant re-duction in VAS pain score was defined in previous stud-ies as 30 mm [25]. A standard deviation (SD) of 10.3 [26], probability of a type I error of 0.05, and power of 0.9 yielded an estimated sample size of 27 for each group (54 patients). For this calculation, G*Power v.3.1.9.2 was used. Consequently, 62 patients were recruited.
PASW v.18.0 for Windows (SPSS, Inc., Chicago, IL, USA) was used for statistical analysis. Mean values and frequencies of the parameters were assessed using de-scriptive statistics, and the normality of the distribution of variables was analyzed using the Kolmogorov-Smirnov test. Descriptive statistics are expressed as mean 6 SD, range, and median for continuous variables, and percentage (%) for categorical variables. The Wilcoxon signed-rank test was used to compare intra-group differences, and the Mann-Whitney U test was used to compare intergroup differences. The statistical significance level was set at P < 0.05. Post hoc power analysis was conducted to measure the power of the present study using G*Power v.3.1.9.2.
Results
In total, 62 patients completed the treatment and evalu-ation. Mean age of the patients was 59.98 6 10.14 years. There was no statistically significant difference in initial sociodemographic data between the treatment group (N¼ 30) and control group (N ¼ 32) (P > 0.05) (Table 1). Significant improvement was observed in all parameters in the treatment group post-treatment (P < 0.001). All parameters of pain and functional status in the treatment group were significantly better than those in the control group post-treatment (P < 0.001). Clinical evaluations are shown inTables 2 and 3. Post hoc ef-fect sizes of the post-treatment findings were calcu-lated, which showed that the effect size of the study was large (Table 2).
Discussion
In the present study, significant improvement was observed post treatment in shoulder ROM, the severity of pain, and functional status in the treatment group, vs significant improvement only in active external rotation and flexion angles, and patient and doctor global as-sessments in the control group. All of the study param-eters were significantly better in the treatment group post-treatment.
The literature includes a few studies on the effect of acupuncture on SAIS. One study on combined single-point acupuncture and physiotherapy that included 425 patients with SAIS reported that the acupuncture group had significantly better functional status than the physiotherapy-only group [27]. Another study with a 12-month follow-up compared 10 sessions of combined acupuncture and exercise to corticosteroid injection and reported that there was significant improvement in both groups [28]; however, a Cochrane analysis of the effect of acupuncture on shoulder pain reported that acupunc-ture was more effective than sham acupuncacupunc-ture in the short term. A recent meta-analysis showed that acu-puncture was an effective treatment method for SAIS [29]. In the present study, acupuncture points previously reported to be effective for the treatment of shoulder pain were used. The majority of these points were located around the shoulder, on the shoulder capsule, and at the Figure 2 Acupuncture points for subacromial
subacromial interval. These points were stimulated using LILT, which is easy to administer and noninvasive and is not associated with any side effects [30,31]. To date, no standard treatment protocol for laser acupuncture (dose and wavelength) has been published.
It remains unclear whether satisfactory results can be obtained by stimulating the acupuncture points with LILT only, without needle penetration [10]. The skin and the subdermal tissue are obvious barriers to absorption of laser rays. In addition, such factors as the thickness of the administration area, patient age, skin color, and
local collagen anisotropy can affect the optical proper-ties of the skin [10]. These factors are typically not given much consideration when laser treatment is adminis-tered [10]. Nevertheless, it is thought that laser acu-puncture is as effective as needle acuacu-puncture due to neural blockade at the skin level [32].
Owing to the nature of LILT, it can be easily used as a sham, as the laser causes no noticeable sensation when the acupuncture points are irradiated. Sham ad-ministration of laser acupuncture is unequivocal on ac-count of the nonvisible infrared wavelengths used. The
Table 1
The comparison of the sociodemographic features
Variables Category Group-1 (LILT) Group-2 (Sham LILT) P
Age (y), mean (range) 64.5 (31–75) 63 (32–70) 0.296
Gender, N (%) Female 21 (70) 22 (68.8) 0.916
Male 9 (30) 10 (31.3)
BMI, mean (range) 25.55 (21.98–33.51) 24 (20.86–32.02) 0.218
Work status, N (%) Unemployed 19 (63.3) 19 (59.4) 0.632
Working 5 (16.7) 4 (12.5)
Retired 6 (20.0) 9 (28.1)
Education level, N (%) Primary 10 (33.3) 5 (15.6) 0.112
Middle 9 (30) 11 (34.4)
High 11 (36.7) 16 (50)
BMI¼ body mass index; LILT ¼ low intensity laser therapy.
Table 2
The comparison of clinical features of two groups
Group 1 Group 2
Group 1–2 Effect size
Mean 6 SD, median (min–max) Mean 6 SD, median (min–max)
Week 0 Week 4 P Week 0 Week 4 P P Cohen d
VAS 2.36 6 2.20 0.56 6 0.93 0.00 2.84 6 2.39 3.62 6 1.93 0.208 0.00* 2.01 Rest 2 (0–7) 0 (0–3) 3 (0–7) 4 (0–7) VAS 7.0 6 1.59 2.30 6 1.48 0.00 6.5 6 1.31 6.03 6 1.37 0.085 0.00* 2.61 Activity 7 (4–9) 3 (0–6) 7 (4–9) 7 (3–8) VAS 6.5 6 2.37 1 6 1.48 0.00 6.15 6 2.08 5.46 6 2.09 0.052 0.00* 2.46 Night 8 (0–9) 0 (0–5) 7 (2–9) 6 (0–8) PGA 6.40 6 1.49 1.73 6 1.01 0.00 6.75 6 0.98 5.93 6 1.45 0.001 0.00* 3.36 7 (4–9) 2 (0–4) 7 (5–9) 6 (2–8) DGA 6.0 6 1.33 1.46 6 1.04 0.00 6.5 6 1.01 5.84 6 1.46 0.010 0.00* 3.45 6 (4–9) 1 (0–4) 6 (5–9) 6 (2–8) SPADI 35.73 6 8.01 14 6 5.78 0.00 37.0 6 7.02 34.5 6 9.55 0.00 0.00* 2.59 Pain 38 (18–50) 12.5 (5–23) 37 (22–48) 35.5 (12–52) SPADI 42.26 6 14.92 15.83 6 9.52 0.00 44.56 6 10.8 41.62 6 10.48 0.010 0.00* 2.57 Disability 43.5 (16–65) 13 (2–35) 40 (24–65) 38.5 (20–64) SPADI 77.66 6 21.98 31.23 6 14.7 0.00 81.65 6 16.76 76.12 6 18.6 0.00 0.00* 2.67 Total 80 (38–112) 33.5 (8–57) 76.5 (49–109) 74 (36–109)
DGA¼ doctor’s global assessment; PGA ¼ patient’s global assessment; SPADI ¼ shoulder pain disability index; VAS ¼ visual analog scale.
combination of the two methods, the high technology of lasers combined with the glamour of acupuncture, might be considered to culminate in a super-placebo ef-fect [10]. In addition to this super-placebo effect, as the analgesic effect of LILT on the shoulder capsule and the laser acupuncture points increase exercise capacity, these treatments may be more effective when combined with exercise [31].
A recent meta-analysis of surgical and nonsurgical treat-ment in 2,300 SAIS patients reported that, whereas LILT alone was not effective, LILT combined with exer-cise was effective [29]. A randomized controlled study that included 80 patients with SAIS compared LILT (10 sessions for four points at a dose of 2–4 joules/cm2, at 890 nm, total dose ¼ 16 joules per session) plus exer-cise with sham LILT plus exerexer-cise and reported signifi-cant improvement in all VAS scores and ROM measurements in the LILT group [8]. Another study car-ried out in patients with SAIS compared laser and exer-cise with exercise only; 10 laser sessions were administered at 904 nm and 1.6 joules per session, and there wasn’t a significant difference between groups re-garding night pain and SPADI scores [33]. When these studies are analyzed, it appears that LILT doses and ap-plication times are very low.
A study of adhesive capsulitis for which NSAID treat-ment and physiotherapy were not effective reported that three sessions of laser acupuncture administered to two acupuncture points for eight weeks (5.4 joules per point; total dose ¼ 10.8 joules) was effective based on two years of follow-up; however, the lack of a control group and low treatment dose limit the findings’ ability to ad-equately demonstrate LILT’s effectiveness for shoulder pain. In the present study, low-intensity laser was ad-ministered to 11 acupuncture points at 4 joules/cm2 (total dose per session ¼ 44 joules/cm2; 15 sessions. To the best of our knowledge, only one other study re-ported using a similar treatment protocol. Eslamian et al. [34] administered a total dose of 40 joules per session for 10 sessions given three days per week in
patients with rotator cuff syndrome and reported that the treatment was effective for pain and functional sta-tus, but not for ROM. The 11 acupuncture points used in the present study were located around the shoulder, which is a wide area. We think that the higher dose and longer course of treatment used in the present study, as compared with the earlier study, were associated with the observed positive effects on SAIS. In addition, the present findings are strengthened by the inclusion of a control group and the use of a hot pack and exercise treatment. The significant improvement noted in the sham group might have been due to the previously re-ported positive effect of exercise on SAIS and the super-placebo effect of the laser.
The lack of differences in treatment administration, with respect to the absorption level of laser rays, according to individual patient characteristics, could be considered a limitation of the present study. A few studies have taken into account the depth of acupuncture points; nevertheless, there is no detailed study on SAIS. In add-ition, the lack of follow-up evaluations is another limita-tion. The duration of treatment effectiveness is an important factor, and additional studies with longer follow-up periods are necessary.
In conclusion, laser acupuncture administered to a suffi-cient number of acupuncture points around the shoul-der and distal points at suitable doses reduced pain and improved ROM and functional status in patients with SAIS. To the best of our knowledge, the present study is the first to report the effectiveness of laser acu-puncture for SAIS. We think that the present findings should be used as the basis for longer-term laser acu-puncture studies that examine different acuacu-puncture points and different wavelengths.
Acknowledgments
We are indebted to the patients for their contributions.
Table 3
The comparison of the range of motions of two groups
Group 1 Group 2 Group 1–2 Week 0 Week 4 P Week 0 Week 4 P P
Mean 6 SD Mean 6 SD Mean 6 SD Mean 6 SD
FLX-active 136 6 27.86 163.06 6 23.80 0.00 140 6 29.21 143.75 6 28.31 0.001 0.00* FLX-passive 158.33 6 28.41 171.33 6 14.79 0.001 156.87 6 27.61 158.59 6 26.09 0.039 0.039* ABD-active 135.66 6 27.75 160.66 6 26.38 0.00 138.43 6 22.34 140.93 6 20.76 0.101 0.001* ABD-passive 162.0 6 29.29 171 6 19.71 0.002 156.7 6 21.12 159.06 6 20.88 0.017 0.006* ER-active 66.16 6 19.19 81.66 6 14.22 0.00 68.75 6 14.36 71.40 6 14.09 0.004 0.002* ER-passive 75.16 6 16.58 83.16 6 11.92 0.001 78.90 6 12.03 79.21 6 11.64 0.157 0.052
ABD¼ abduction; ER ¼ external rotation; FLX ¼ flexion. *p< 0.001.
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