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CRE0010.1177/0269215520941059Clinical RehabilitationAbdel-Aal et al.
CLINICAL
Original Article REHABILITATION
Clinical Rehabilitation
erythematosus: a double-blinded,
randomized controlled trial
Abstract
Objective: To determine the efficacy of high-intensity laser therapy (HILT) on arthropathy of the hands
in patients with systemic lupus erythematosus.
Design: A double-blinded randomized, controlled study.
Setting: Outpatient setting
Participants: Fifty patients, 30–50-years-old, suffering from arthropathy of the hands were randomly
assigned either into the experimental group, received HILT plus the routine physical therapy program or
the control group, received sham HILT plus the same routine physical therapy program.
Intervention: All treatment interventions were applied at a frequency of three sessions per week for
eight weeks.
Outcome measures: Handgrip strength, joints swelling counts, joints tenderness counts, visual analog
scale (VAS) were measured before and after eight-weeks of interventions.
Results: There were statistically significant differences in handgrip strength, joint swelling count, joint
tenderness count and VAS in favor of the study group (P < 0.05). After eight-weeks of intervention,
the mean (SD) for handgrip strength, joint swelling counts, joint tenderness count, and pain score
was 28.34 ± 8.3 kg, 4.4 ± 2.18, 5 ± 2.1, and 35.6 ± 13.87 mm in the study group, and 22.96 ± 8.76 kg,
7.36 ± 2.14, 9.08 ± 1.63, and 58.8 ± 10.54 mm in the control group, respectively. The MD (95%CI) for
handgrip strength, joint swelling counts, joint tenderness count, and pain score was 5.38(0.53,10.23) kg,
−2.96(−4.19, −1.73), −4.08(−5.15, −3.01), and −23.2(−30.2, −16.2) mm between groups, respectively.
1
epartment of physical therapy for Basic Sciences, Faculty of
D Corresponding author:
Physical Therapy, Cairo University, Giza, Egypt Nabil Mahmoud Abdel-Aal, Department of Physical Therapy
2
Department of physical therapy for Surgery, Faculty of for Basic Science, Faculty of Physical Therapy, Cairo
Physical Therapy, Cairo University, Giza, Egypt University, 7th Ahmed Elzayat St., Been Elsarayate, Dokki,
Giza, P.O. 11432, Egypt.
Emails: nabil.mahmoud@cu.edu.eg; nabil_45@hotmail.com
2 Clinical Rehabilitation 00(0)
Conclusions: Adding HILT to the routine physical therapy program might be more effective than routine
physical therapy program alone in improving handgrip strength, decreasing joint swelling counts, joint
tenderness counts, and pain in patients with arthropathy of the hands.
Keywords
High-intensity laser, arthropathy of the hands, handgrip strength, joint swelling and tenderness, pain
met the inclusion criteria of being between the age fingers to relieve joint pain and increase the range
of 30–50 years, females’ subjects, less than one of motion. Strengthening exercises were in the
year since the beginning of the disease, and up to form of isometric exercise for hand muscles and
two years with systemic lupus erythematosus from fingers to maintain muscles strength, and joints
diagnosis. Patients were excluded if they had one flexibility.20,21
or more of the following: positive rheumatic factor, Patients in the study group received high-inten-
circulatory disorders, neurological disease, diabe- sity laser therapy with neodymium- yttrium alu-
tes, pregnant woman, communication problems, or minum garnet (Nd:YAG) laser, produced by a
skin diseases. Those who refused to join the study, HIRO 3 device (ASA Laser, Arcugnano, Italy)
or to sign the written consent form were excluded three sessions per week, over eight successive
as well. weeks. The device is equipped with a standard
Apriori sample size was calculated by G*Power handpiece endowed with a fixed spacer and has a
(version 3.1.9.2; Germany,) [F tests- MANOVA: diameter of 0.5 cm and a spot size of 0.2 cm2.15,16,18
Repeated measures, within-between interaction], During the application of high-intensity laser
with effect size equals 0.56,19 80% power analysis therapy, safety procedures were taken to prevent its
and a two-sided 5% significance level. Therefore, adverse events. Both patient and the treating inves-
the total estimated sample size was thirty-nine tigator wore specific eye protection goggles to pre-
patients, and the number increased by 15% to be 45 vent damage to the retina of eyes. The treating
patients to consider the drop out from the time of investigator moved the laser probe constantly to
randomization to the end of the treatment protocol. prevent discomfort from its thermic effects.
Fifty female patients were randomly assigned Patients were informed that some of them might
equally to high-intensity laser therapy and routine experience an exacerbation of their symptoms
physical therapy program (study group) or sham shortly after treatment because of a burst of inflam-
high-intensity laser therapy and the same routine mation. Patients were reassured that inflammation
physical therapy program (control group) using has to take place so that a therapeutic effect is tak-
computer-generated block randomization. The ing place.
block size was four to eliminate selection bias and The participants were treated while assuming a
reduce the variability between the two groups. sitting position, with their hand rested at the table.
Concealed allocation was done by the use of sealed, In every session, the total energy dose of high-
sequentially numbered opaque envelopes. intensity laser therapy was 2100 J and was applied
Randomization was generated by the first author in three phases of treatment. The first phase was
who was not involved in data collection. The sec- performed with fast scanning (60 cm2/30 s) applied
ond author opened the envelope, and hence pro- transversely and longitudinally around the wrist,
ceeded with treatment according to group hand, and the fingers with three respective fluen-
allocation. Data collection at baseline and after the cies set at 510, 610, and 710 mJ/cm2 for a total dose
end of the intervention period were done by the of 300 J. The second phase was performed by hold-
third author who was blinded to group allocation. ing the handpiece vertically to 90° on a total of 10
fixed points around the metacarpophalangeal, and
interphalangeal joints. In this phase, each point was
Interventions radiated for 15 s, using a fluency of 710 mJ/cm2,
All patients of the study and control groups 150 J/point, and a total dose of 1500 J. The third
received the same routine physical therapy pro- phase was the same as the first phase, but at a much
gram for 30 minutes, and three times per week for slower rate (60 cm2/60 s) with a total energy of 300
eight weeks in the form of hot therapy, stretching J. The total time of high-intensity laser therapy was
and strengthening exercises. Hot therapy, in the approximately 10 minutes for all phases. Patients
form of warm baths for 10 minutes, was applied in the control group received sham high-intensity
before stretching exercises on the wrist joint and laser therapy, where all parameters were set up
4 Clinical Rehabilitation 00(0)
without switching on the start button and high- Descriptive statistics were conducted for compari-
intensity laser therapy machine was switched on son of subject characteristics between and within
with a visible light beam only. groups. Normal distribution of data was checked
The outcome measures included handgrip using the Shapiro-Wilk test for all variables.
strength, tender joints count, swollen joints count, Levene’s test for homogeneity of variances was
and visual analog scale. All assessments were con- conducted to test the homogeneity between groups.
ducted pre and post-treatment by one of the authors Mixed MANOVA was performed to compare
who was blind to groups’ assignment. within and between groups effects on hand strength,
joint swelling, joint tenderness and VAS. The F
•• Handgrip strength measured by Jamar hand- value used based on Wilks’ lambda and Partial
held dynamometer device 12-0600. It is graded squared eta was considered as the effect size. When
from zero to two hundred pounds and from the MANOVA demonstrated a significant effect
zero to ninety kilograms.9 Handgrip strength (P < 0.05), a follow-up univariate ANOVAs was
was measured with the elbow at about 90° performed. Post-hoc tests using the Bonferroni cor-
according to the recommendations of American rection were carried out for subsequent multiple
Society of Hand Therapists.22 Three consecu- comparisons to protect against the possibility of the
tive measurements were performed with a two type I error. The level of significance for all statisti-
minutes inter-measurement interval, and the cal tests was set at P < 0.05.
mean strength value of the three trials was cal-
culated and considered as the handgrip
Results
measure.
•• Joint tenderness count was the sum of the ten- The patients flow diagram throughout the study is
der joints at the dominant hand before and after shown in Figure 1. No patient complained or
the treatment.23 reported adverse effects during or after high-inten-
•• Joint swelling count was the sum of the swollen sity laser therapy application. The demographic
joints at the dominant hand before and after the data of all patients at the baseline for the study and
treatment.23 control groups are given in Table 1. No statistically
•• Visual Analog Scale was used for measuring significant differences were found between groups
the pain intensity. It is a horizontal continuous for baseline demographic characteristics (P > 0.05).
line of 100 mm, starting with no pain at the left The results showed no statistically significant
side and end with worse pain at the right side of differences between groups regarding handgrip
the line. The patients were asked to mark on the strength, number of joints swelling, number of
visual analog at the point that represents their joints tenderness, and pain at baseline (P > 0.05).
pain intensity. Then, the researcher measures After treatment, there was a significant increase in
the distance (mm) on the line between the “no handgrip strength of the study group compared
pain” at the left side end and the patient’s mark, with that of the control group (P = 0.031), and a sig-
providing a range of scores from 0–100 mm.24 nificant decrease in joint swelling count, joint ten-
derness count and pain of the study group compared
with that of the control group (P < 0.001) as shown
Statistical analysis in Table 2.
Statistical analysis was performed using SPSS Two way mixed design multivariate analysis
software for Windows, version 25.0 (Chicago, IL, was conducted to assess the difference between
USA). Intention to treat analysis was conducted, in patients in the study and control groups in the
which the last observation carried forward model amount of change in their scores on the four out-
used for the missing data. This technique uses the come measures. Significant multivariate effects
last recorded value for each outcome measure and were found for the effect of treatment, Wilk’s
applying it to the remaining missing value(s).25 A = 0.54; F(4, 45) = 9.69, P < 0.001, η2 = 0.46; time,
Abdel-Aal et al. 5
Figure 1. Flow diagram showing the progress of subjects at each stage of the clinical trial.
Wilk’s A = 0.03; F(4, 45) = 363.23, P < 0.001, (P < 0.001). Also, there was a significant decrease
η2 = 0.97; and the interaction of treatment and time, in number of joint swelling, joint tenderness and
Wilk’s A = 0.19; F(4, 45) = 47.35, P < 0.001, η2 = 0.81. pain after treatment compared with that before
Follow-up univariate ANOVAs showed significant treatment in both groups (P < 0.001) as in Table 2.
change for handgrip outcome variable, F(1,48) = 4.97,
P = 0.031, η2 = 0.094; for joint swelling outcome
Discussion
variable, F(1,48) = 23.49, P < 0.001, η2 = 0.33; for
joint tenderness outcome variable, F(1,48) = 58.81, The finding of this study revealed that there was a
P<0.001, η2 = 0.55; and Visual Analog Scale out- statistically significant improvement in handgrip
come variable, F(1,48) = 44.36, P < 0.001, η2 = 0.48. strength of the study group compared with that of
Within-group comparison: There was a signifi- the control group (P = 0.031). Also, there was a sta-
cant increase in handgrip strength in each group tistically significant decrease in joint swelling
after treatment compared with that before treatment counts, joint tenderness counts, and pain of the
6 Clinical Rehabilitation 00(0)
Outcomes HILT group Sham HILT group Mean difference 95% CI P value
(n = 25) (n = 25)
Age (years) 41.48 ± 5.09 40.16 ± 5.98 1.32 (−1.84, 4.48) 0.41
SLE duration (Months) 14.8 ± 3.04 15.88 ± 3.73 −1.08 (−3.02, 0.86) 0.27
Arthritis duration (Months) 5.44 ± 2.06 6.32 ± 2.06 −0.88 (−2.05, 0.29) 0.14
Dominance, n (%) 20(80)/5(20) 23(92)/2(8) X2 = 1.5 - 0.22
Right/Left
Marital status, n (%) 15(60)/10(40) 10(40)/15(60) X2 = 2 - 0.16
Single/Married
Education level, n (%) 15(60)/10(40) 18(72)/7(28) X2 = 0.8 - 0.37
Secondary/University
Employment, n (%) 13(52)/12(48) 9(36)/16(64) X2 = 1.3 - 0.26
Employed/Unemployed
HILT: High-Intensity Laser Therapy; CI: Confidence Interval; SLE: systemic lupus erythematosus; X2: Chi-square.
*Data are mean ± SD, P-value <0.05 indicate statistical significance.
study group compared with that of the control group laser therapy superior to conventional therapy for
(P < 0.001). The results of the current study might the improvement of joints function and decrease
prove that high-intensity laser therapy with tradi- pain.15,27,32–34
tional physical therapy program have greater effec- Despite the benefits exercises, patients with
tive strategies in improving handgrip strength, and chronic pain often reduced their mobility or refrain
reducing joint swelling, joint tenderness, and pain to do any physical activities to avoid pain. This
than conventional physical therapy alone. In within leads to muscle weakness, decrease range of
group comparison, there was a significant increase motion, increase joint stiffness and decrease physi-
in handgrip strength (P < 0.001), and a significant cal performance.34 Adding high-intensity laser
decrease in joint swelling counts, joint tenderness therapy to exercises, in the current study, encour-
counts, and pain (P < 0.001) after treatment com- aged the patients to do more physical activities,
pared with that before treatment in both groups. significantly improved the handgrip strength, and
Pulsed Nd:YAG laser therapy, a form of high- decrease joint pain as high-intensity laser therapy
intensity laser therapy, has been used for a wide slows the transmission of the pain stimulus and
range of conditions.15–17,26–29 The analgesic effect increases the production of morphine-mimetic sub-
of high-intensity laser therapy is based on different stances in the body.10,31,32
mechanisms of action.10,30,31 The treatment might The biological effect of high-intensity laser
also increases blood flow, vascular permeability, therapy depends on its parameters, that is, the
and cell metabolism.14,32 wavelength, mode, pulse duration, energy, and
The current study aimed to investigate the effect power. High-intensity laser therapy (pulsed Nd:
of adding high-intensity laser therapy to the con- YAG) wavelengths have deep penetration energy
ventional physical therapy program on arthropathy which enhance cell metabolism without any dis-
of the hands of patients with systemic lupus erythe- ruptive changes.35 The photomechanical and ther-
matosus. Most of previous studies focused on the modynamic of Nd:YAG laser cause cellar
efficacy of pulsed Nd:YAG laser on different mus- mechanical stress which enhance cellular bio-stim-
culoskeletal conditions but, to the best of the ulation, venous and lymphatic microcirculations,
authors’ knowledge, no study focused on hands’ the cells mitotic index, extracellular ion transport,
arthritis due to autoimmune disease as systemic and healing process.35,36
lupus erythematosus. The results of this study were According to the results of this study, high-
in line with other studies that found pulsed Nd:YAG intensity laser therapy might be an effective method
Abdel-Aal et al. 7
0.48
0.33
0.55
*Data are mean± SD, P-value <0.05 indicate statistical significance. Negative mean difference scores (95% CI) on visual analog scale, number of joint swelling and tenderness are indicative of
interaction P (η2)
0.1
High-intensity laser therapy could control inflam-
mation by reducing C-reactive protein, neopterin,
interleukin 1, and prostaglandin levels.38 The cur-
Table 2. Outcome data for handgrip, joint swelling, joint tenderness and VAS at baseline and after eight-weeks of intervention (N = 50)*.
independency.41
HILT: High-Intensity Laser Therapy; CI: Confidence Interval; VAS: visual analog scale (based on 100-mm scale); MD: Mean Difference; η2: partial eta square
In this study, the exercise program in the control
group also increased the handgrip strength,
weeks
58.8 ± 10.54
7.36 ± 2.14
9.08 ± 1.63
After eight
11.52 ± 1.94
4.4 ± 2.18
84.4 ± 7.12
11 ± 2.29
VAS (mm)
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