Efficacy of high intensity laser therapy in treatment of patients with lumbar disc protrusion: A randomized controlled trial

Abstract

OBJECTIVE:

This study aims to evaluate the effect of high intensity laser therapy (HILT) in patients with lumbar disc protrusion (LDP).

METHODS:

This study included 63 patients suffering from protrusion of lumbar intervertebral disc; they were divided into Groups 1 ( $n=$ 32) and 2 ( $n=$ 31). Group 1 was treated with HILT and spinal decompression system (SDS). Patients in Group 2 received SDS alone. Evaluations were conducted on oswestry disability index (ODI), lumbosacral portion pain, and lower limb radiation pain with visual analogue scale (VAS) of two patient groups before treatment, two weeks after treatment, and 1 month after follow-up visit. Lumbar flexion range and angle of straight leg raising before treatment and 2 weeks after treatment.

RESULTS:

After two weeks of treatment of two patient groups, ODI, VAS, lumbar flexion range and angle of straight leg raising significantly improved compared with their conditions before treatment ( $P<$ 0.01). A significant difference was noted in ODI, lumbar flexion range, and angle of straight leg raising between groups after two weeks of treatment ( $P<$ 0.05). Non-statistical significant difference was observed in lumbosacral portion pain and lower limb radiation pain with VAS ( $P>$ 0.05). However, difference in was VAS smaller in Group 1. All groups showed significantly different results in terms of ODI, lumbosacral portion pain, and lower limb radiation pain with VAS.

CONCLUSION:

As one of available treatments for LDP, HILT can speed up improvement in lumbar segment motion, angle of straight leg raising, and overall function and allow early return of patients to their family and society. Treatment effect is long-lasting and can be widely promoted and applied clinically.

Keywords

High intensity laser lumbar disc protrusion spinal decompression system

Table 1
Comparison of general conditions and illness state of two patient groups

Item	Group 1 ( $n=$ 32) ( $\bar{{x}}$ $\pm$ s)	Group 2 ( $n=$ 31) ( $\bar{{x}}$ $\pm$ s)	$P$ value
Age (year)	39.27 $\pm$ 12.58	43.00 $\pm$ 12.19	0.288
Gender (male/female)	22/10	19/12	0.533
Height (cm)	166.00 $\pm$ 6.47	166.93 $\pm$ 7.67	0.646
Weight (kg)	59.74 $\pm$ 7.10	62.34 $\pm$ 7.16	0.201
Course of disease this time (day)	4.01 $\pm$ 1.78	4.17 $\pm$ 2.42	0.206
Total course of disease (month)	22.53 $\pm$ 17.87	20.43 $\pm$ 19.15	0.430
Body mass index (kg/m ${}^{2}$ )	21.68 $\pm$ 2.42	22.79 $\pm$ 2.43	0.108
LDP part (case)	(%)	(%)
L3/L4	7 (21.88%)	6 (19.35%)	1.131
L4/L5	23 (71.88%)	22 (70.97%)	1.013
L5/S1	10 (31.25%)	11 (35.48%)	0.881
Multilevel	8 (25.00%)	8 (25.81%)	0.969
With lower limb radiation pain (case)	11 (34.38%)	13 (41.94%)	0.820

1. Introduction

Lumbar disc protrusion (LDP) is one of the most common causes of low back pain (LBP) [1]. A survey revealed that 70%–85% of people suffer from LBP, annual incidence rate reaches as high as 15%–45% [2], and 26.3 million dollars is used for health care of LDP every year, causing serious economic burden to the society [3]. Therefore, studies on such a disease focus on seeking economical and effective treatment methods.

At present, patients with protrusion of lumbar intervertebral disc (PLID) mainly adopt conservative treatments. As one of conservative treatment methods, spinal decompression system (SDS) became an effective treatment method for PLID [4, 5]. As irritation and compression of protruding lumbar intervertebral disc on nerve root also cause inflammatory reaction of local tissues, better improvement effect can be observed with SDS in mechanical compression of lumbar intervertebral disc on nerve roots. Chemical irritation around nerve roots and recovery of muscle function often require complementary physical therapies.

High intensity laser therapy (HILT) is a new application of laser treatment. This procedure is painless, noninvasive and convenient, realizes large-area mobile action on body surface, and effectively stimulates deep tissues, with functions including anti-inflammation, anti-pain, and detumescence effects [6, 7, 8, 9, 10]. Studies proved that HILT significantly affects chronic LBP [6, 11], gonitis [12, 13], shoulder pain [14], and diabetic foot ulcer trauma repair [15]. This method can reduce pain with improvement of bodily functions.

This study uses oswestry disability index (ODI) [16], visual analogue scale (VAS) [17], lumbar flexion range [18], and angle of straight leg raising [19] to evaluate effects of HILT in patients with LDP. This study explores economic and effective methods for treatment of LDP.

2. Materials and methods

2.1 General materials

A total of 63 patients suffering from PILD accepted treatment in the Rehabilitation Department of Third Affiliated Hospital of Southern Medical University from December 2015 to November 2016. Patients were divided into Groups 1 ( $n=$ 32) and 2 ( $n=$ 31) according to a random number table, and they showed no significant difference ( $P>$ 0.05) in age, gender, height, body mass index, course of disease and other aspects, thus ensuring comparability. Details are provided in Table 1. This study was approved by the Medical Ethics Committee of our hospital. Patients provided consent and signed informed consent forms.

2.2 Inclusion criteria and exclusion criteria

Inclusion criteria were as follows: (1) patients who were diagnosed with PLID upon computed tomography or magnetic resonance imaging examination of lumbar vertebrae; (2) patients who suffered from LBP or lower limb pain with typical lumbosacral nerve root radiation pain [20]; (3) patients aged 18–60 years old; (4) patients who did not undergo systematic rehabilitation one month before the study; (5) patients who signed informed consent forms and volunteered to participate in tests.

Exclusion criteria were as follows: (1) patients with combined lumbar spondylolisthesis, bony spinal canal stenosis, fracture of lumbar vertebra or spinal structure dysplasia (spondylolysis.); (2) patients with spinal tuberculosis and tumor; (3) patients who underwent lumbar spinal fusion or exhibited operation indications; (4) patients with serious heart, liver, and kidney diseases and tumors; (5) pregnant patients; (6) patients with serious osteoporosis; (7) patients who presented tattoo or melanocytic nevi in or near treatment areas; (8) patients with lupus or any other autoimmune diseases, thrombophlebitis or anemia, and skin hypersensitivity; (9) patients who did not receive therapies as required.

2.3 Intervention method

SDS: DRX9000 SDS was used. Patients lay in supine position, and their gender, height, weight, vertebral lesions location, and other parameters were encoded into the instrument before traction. During the first treatment, tractive force was 50% of patient’s weight and was adjusted according to patient’s actual tolerance (with adjustment range of 2–5 kg). Treatment segment was determined according to patient’s pain location and imaging data, and traction angle was adjusted according to treatment segments. Each treatment was performed 28 times, lasted for 30 s, and completed 12 tension cycles. Patients were treated for five days every week, with two consecutive weeks of treatment considered as one course of treatment.

HILT: BTL-6000 HILT was used. The device utilized gallium-arsenide diode laser (BTL-6000 laser) and manually set to biostimulation mode with power of 12 W, 150 J/cm ${}^{2}$ , wavelength measuring 1064 nm, and spot beam diameter area of 1 cm ${}^{2}$ . Under these conditions, laser was applied with continuous movements. In one session, total energy delivered to patient measured 7500 J through three phases of treatment. The initial phase was performed with fast manual scanning with a total energy of 3000 J. In the intermediate phase, key treated areas comprised pain points between rib inferior margin and posterior superior iliac spine, utilizing 1500 J total energy. The final phase was the same as the initial phase except that slow manual scanning was employed. Application time for all three phases lasted for 10 min with the total energy delivered to patients reaching 7500 J during one session. Patients lay in prone position. Treatment probe was placed vertical to the skin and horizontally moved along the skin. Treated areas were located between rib inferior margin and posterior superior iliac spine. Patients were treated for five days a week, with two consecutive weeks of treatment considered as one course of treatment.

Group 1 was treated with HILT and SDS. Patients in Group 2 only received SDS.

2.4 Evaluation standards of curative effect

Evaluation was performed on ODI, lumbosacral portion pain, and lower limb radiation pain with VAS of two patient groups before treatment, two weeks after treatment, and one month after follow-up visit. Lumbar flexion range and angle of straight leg raising were observed before and two weeks after treatment. Clinical effect time was observed in the two groups.

2.4.1 ODI

ODI consisted of 10 items, including pain degree, personal life and self-help ability, carrying, walking, sitting, standing, sleep, sexual life, social life, and travel. Each item incurred 0–5 points according to actual situations, with total scores within 0–50 points. Higher score indicated more serious dysfunction.

2.4.2 VAS

Subjects placed a mark in a 10-cm-long segment according to pain sensation. The left end received 0 score, indicating absence of pain pain, whereas the right end was scored 10, representing the most intense pain. VAS was used to evaluate degree of lumbosacral portion pain and lower limb radiation pain.

2.4.3 Lumbar flexion range

The distance between tip of middle finger to ground was measured while patients were standing. Patients bent forward to reach spine limit, and distance between tip of middle finger to ground was measured again. The difference between two distances was calculated and recorded.

2.4.4 Angle of straight leg raising

Patients lay in spinal position and extended both lower limbs. The examiner held the affected knee of the patient with one hand to extend the knee joint and held the ankle with the other hand to raise it slowly until the patient presented radiation pain in lower limbs; the angle between lower limb and bed surface was recorded.

Table 2
Comparison of test results in ODI, lumbosacral portion pain with VAS, lumbar flexion range, and angle of straight leg raising of two patient groups before treatment, after treatment, and during follow-up visit ( $\bar{{x}}$ $\pm$ s)

Item	Time	Group 1 ( $n=$ 32) ( $\bar{{x}}$ $\pm$ s)	Group 2 ( $n=$ 31) ( $\bar{{x}}$ $\pm$ s)	$P$ Value
ODI (score)	Before treatment	21.23 $\pm$ 7.24	20.03 $\pm$ 6.0	0.52
	Two weeks after treatment	6.05 $\pm$ 4.72	9.47 $\pm$ 5.08	0.02
	One month after follow-up visit	3.14 $\pm$ 2.03	7.93 $\pm$ 3.93	$<$ 0.001
$P$ value		$<$ 0.001	$<$ 0.001
Lumbosacral portion pain	Before treatment	6.73 $\pm$ 1.17	6.77 $\pm$ 1.22	0.91
VAS (score)	Two weeks after treatment	1.95 $\pm$ 1.12	2.22 $\pm$ 1.01	0.38
	One month after follow-up visit	1.18 $\pm$ 0.91	2.03 $\pm$ 1.00	$<$ 0.001
$P$ value		$<$ 0.001	$<$ 0.001
Lumbar flexion range (cm)	Before treatment	34.66 $\pm$ 17.68	38.27 $\pm$ 15.78	0.44
	Two weeks after treatment	56.00 $\pm$ 9.04	49.55 $\pm$ 10.29	0.02
$P$ value		$<$ 0.001	$<$ 0.001
Angle of straight leg raising ( ${}^{\circ}$ )	Before treatment	39.01 $\pm$ 8.37	41.07 $\pm$ 9.61	0.53
	Two weeks after treatment	77.14 $\pm$ 10.76	71.37 $\pm$ 7.63	0.03
$P$ value		$<$ 0.001	$<$ 0.001

Table 3

Comparison of results for lower limb radiation pain with VAS in two patient groups before treatment, after treatment, and during follow-up visit ( $\bar{{x}}$ $\pm$ s)

Item	Time	Group 1 ( $n=$ 11) ( $\bar{{x}}$ $\pm$ s)	Group 2 ( $n=$ 13) ( $\bar{{x}}$ $\pm$ s)	$P$ value
Lower limb radiation pain	Before treatment	7.59 $\pm$ 0.92	7.69 $\pm$ 0.75	0.77
VAS (score)	Two weeks after treatment	3.15 $\pm$ 1.24	3.69 $\pm$ 1.03	0.14
	One month after follow-up visit	1.45 $\pm$ 1.13	3.40 $\pm$ 1.05	$<$ 0.001
$P$ value		$<$ 0.001	$<$ 0.001

2.5 Statistical analysis

Measurement data in this study were expressed as ( $\bar{{x}}$ $\pm$ s), and SPSS 20.0 statistical software package was used for data analysis. T-test and single-sample variance analysis were carried out, and $\chi^{2}$ test was used for comparison of measurement data. $P<$ 0.05 indicated statistically significant difference. Bonferroni was used for back testing.

3. Results

The two patient groups showed no statistical significance difference in ODI, VAS, lumbar flexion range, and angle of straight leg raising before treatment ( $P>$ 0.05). After two weeks of treatment, ODI, VAS, lumbar flexion range, and angle of straight leg raising of two patient groups significantly improved compared with their conditions before treatment ( $P<$ 0.01). Group 1 presented more significant degrees of improvement in ODI, lumbar flexion range, and angle of straight leg raising, and compared with Group 2, their differences were statistically significant ( $P<$ 0.05). Group 1 also showed more significant degrees of improvement in lumbosacral portion pain and lower limb radiation pain VAS, and compared with Group 2, their differences were not statistically significant ( $P>$ 0.05). One month after follow-up, compared with Group 2, statistically significant difference was noted in ODI, lumbosacral portion pain, and lower limb radiation pain with VAS of Group 1 ( $P<$ 0.05). Details are described in Tables 2–3.

4. Discussion

PLID is a syndrome that causes pathological chan- ges, including necrocytosis, exudation, edema and other inflammations, local microcirculation changes, muscle vasospasm, diseased tissue ischemia, hypoxia and edema, lesion area pain due to increases in algogenic substance, and decrease in daily life functions due to degeneration of intervertebral disc, anular disruption, nucleus pulposus herniation irritation, or nerve root compression. Treatment for PLID through SDS can significantly improve intervertebral space width in patients and promote reduction in protrusion of intervertebral discs, thus achieving compression removal, pain relief, and recovery of intervertebral disc shape and function. Many studies revealed [21, 22, 23] that SDS is safe and effective in treating protrusion of intervertebral discs. With accurate positioning, whole-course comfort, and other advantages, SDS is one of the most common treatment methods for protrusion of intervertebral discs. This study only selected patients with PLID treated by SDS. After two weeks of treatment, significant improvement was observed in degree of lumbosacral portion pain and lower limb radiation pain in patients, further verifying that SDS effectively treats protrusion of intervertebral discs.

As effective means of physical factor therapy, lasers aid in recovery of tissue structure and pain relief [24, 25, 26] by speeding up tissue metabolism, strengthening mitochondrial activity, promoting cell proliferation and differentiation, and inhibiting apoptosis, thus reducing inflammatory reaction, eliminating oxidative stress and muscle fatigue, inhibiting nociceptive transmission of nerve stimulation, increasing microcirculation, promoting $\beta$ intrinsic factor secretion, and initiating immunoreaction and nerve regeneration. Available therapies feature significant curative effects on acute and chronic pain. Many studies proved that HILT yields better effects in improvement of pain in neck and waist, shoulder and knee joints, and other skeletal and muscular diseases and dysfunction [6, 11, 12, 13, 14]. PLID is characterized by longer course of disease and repeated attacks and is accompanied by low back muscle atrophy and adipose tissue infiltration into muscle, thus decreasing functions of low back muscle group. This study used a HILT instrument, which is a new laser treatment method launched in recent years. This therapy exhibits the same but stronger and immediate photo treatment effect of ordinary lasers, with its wavelength reaching 1064 nm. As human skin does not feature adequate concentrations of endogenous chromophores, during treatments with such wavelength window, lasers penetrates the body more easily, reaches deeper levels, realizes scattering in tissues, increases oxidation reaction of mitochondria, increases generation of ATP, RNA, and DNA, enhances photobiological effects on tissues [27], activates muscles, and improves function of core muscles, thus improving state of patients with PLID and their daily life functions. Furthermore, treatment effect lasts long. According to follow-up visit to patients one month after treatment, compared with Group 2, Group 1 presented statistically significant differences in ODI and lumbosacral portion pain, lower limb radiation pain with VAS ( $P<$ 0.05). This significance may be related to capacity of HILT to activate lumbosacral portion muscle at deeper levels, improve function of surrounding muscle group, and reduce inflammatory pathological reactions around protrusions; these conditions are conducive to consolidating treatment and maintaining effects on patients with PLID.

Study results revealed that Group 1 patients exhibited superior degree of improvement than those in Group 2 in terms of ODI, lumbar flexion range, and angle of straight leg raising. Lumbar segment motion and overall function of patients in Group 1 recovered more rapidly, possibly as a result of treatment of SDS which increased intervertebral space height of affected segments and relieved compression of protrusion to nerve root. HILT of antiphlogosis and detumescence promoted local issue inflammation resolution, local damage repair, and reduction of protrusion in patients with PLID and speeded up function recovery of patients with PLID, coinciding with results of a previous study. Compared with low-level lasers, HILT realizes real-time, dynamic, large-area, deep-level, and large-dose actions on diseased tissues of the body. This treatment also improves multi-segment lesions of patients with PLID, meeting illness state, which plays an important role in relieving pain and promoting functional recovery [28, 29].

Therefore, as one of available treatments for PLID, HILT can speed up improvement of patients’ lumbar segment motion, angle of straight leg raising, and overall function, enable early return of patients to their family and society, and achieve lasting treatment effect, which are all related to capacity of HILT to improve ill states. Hence, HILT deserves clinical promotion and application.

However, this study features certain limitations. This study discussed analysis of clinical curative effects on patients with PLID through HILT and failed to discuss mechanisms of its curative effect. Conducted evaluation only assessed clinical curative effect of subjective indicators and failed to adopt musculoskeletal color ultrasound and other objective evaluation markers. To obtain more accurate, more realistic, and more objective results, treatment effect shall be verified by additional long-term and multiple evaluation indicators and cutting-edge high-quality basic tests and clinical tests.

Footnotes

Acknowledgments

The authors express their appreciation to all subjects who participated in this study with all content and cooperation and give special thanks to their colleagues at the Department of Rehabilitation Medicine, The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong, China.

Conflict of interest

The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

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Efficacy of high intensity laser therapy in treatment of patients with lumbar disc protrusion: A randomized controlled trial

Abstract

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

Table 1 Comparison of general conditions and illness state of two patient groups

2. Materials and methods

2.1 General materials

2.2 Inclusion criteria and exclusion criteria

2.3 Intervention method

2.4 Evaluation standards of curative effect

2.4.1 ODI

2.4.2 VAS

2.4.3 Lumbar flexion range

2.4.4 Angle of straight leg raising

Table 2 Comparison of test results in ODI, lumbosacral portion pain with VAS, lumbar flexion range, and angle of straight leg raising of two patient groups before treatment, after treatment, and during follow-up visit ( x ¯ ± s)

3. Results

4. Discussion

Footnotes

Acknowledgments

Conflict of interest

References

Table 1
Comparison of general conditions and illness state of two patient groups

Table 2
Comparison of test results in ODI, lumbosacral portion pain with VAS, lumbar flexion range, and angle of straight leg raising of two patient groups before treatment, after treatment, and during follow-up visit ( $\bar{{x}}$ $\pm$ s)