Abstract
Introduction
E
There is no correlation between the degree of severity of the illness and how severe the symptoms are, as more severe symptoms can occur in relatively mild cases of endometriosis. 5 Mostly, the pain is localized in the lower abdomen and deep pelvis. It is often described as a dull, aching pain, which patients in severe cases may suffer throughout their cycle. 6 A relationship between infertility and endometriosis is known to exist. The path of the egg to the uterus may be completely blocked by scarring, but fertility can be impaired even in milder cases. 7 Approximately, one quarter of women who had a laparoscopy due to pelvic pain were diagnosed with endometriosis, while it present in 20%, of infertile women, and it fell to 4.1% in women who had received tubal legation. 6,8 Currently, laparoscopy is the only effective means of diagnosing endometriosis to determine the degree of adhesions, which are rated as minimal, mild, moderate, and severe 9,10 by the American Society for Reproductive Medicine.
Endometriosis is present in about 10% of women of reproductive age, with the incidence increasing in middle-aged women. 11 The spectrum of possible symptoms is wide and may include dysmenorrhea, dyspareunia, chronic pelvic pain, and pain related to ovulation, varying with the form and locus of endometrial foci. 12 –14 It can result in fatigue, infertility, abnormal bleeding from the uterus, and problems with the bladder and bowel. It also has negative effects on quality of life, impacting on social life, and work as well as on reproduction and ability to have a family. 15,16 Additional symptoms which may develop include allergies, fibromyalgia, asthma, eczema, autoimmune inflammatory disease, chronic fatigue syndrome, and hypothyroidism, 17 as well as in women diagnosed with the disease after the age of 40, an increased risk of breast cancer due to prolonged exposure to raised levels of endogenous aestrogen. 18
Treatment goals for endometriosis include pain alleviation, preserving fertility and minimizing adhesions. The most common reason for a woman to seek treatment is pain alleviation. 19 However, the ideal medical treatment remains to be developed. All treatments presently available have side effects, and there is no medical therapy effective in improving fertility. 20,21 Retrospective findings show poor long-term symptom reduction from the medical and surgical treatments commonly available, and each is associated with numerous side effects. 22 Medical treatment mimics physiological states; when treatment ends, the symptoms often reoccur; often as early as 6 months after the end of treatment. 23 As medical therapies and surgery require repeated follow-up and have side effects, it is common for patients to resort to low-cost methods that are both nonmedical and nonaggressive. 24
Pulsed high-intensity laser therapy (HILT) penetrates deeply into the tissue, causing chemical and mechanical changes as well as inducing thermal mechanisms. 25 HILT fields have physical properties that may be responsible for observed profibrinolytic effects, including mechanical and thermal effects. HILT is quick to reduce inflammation and painful symptoms. 26 It uses a specific waveform, in which regular amplitude peaks and shot time produce photochemical and photothermic effects in the deep tissues, resulting in increases in blood flow, vascular permeability, cell metabolism, and the tissue's photomechanical level, attaining very fast application times. 27 Therefore, this study aims to determine the effectiveness of pulsed HILT on pain, adhesions, and quality of life in women with endometriosis.
Materials and Methods
Subjects
Forty women from hospitals in Makkah who suffered severe pelvic pain and had been diagnosed by laparoscopy as suffering from mild or moderate endometriosis, as defined by the revised classification of endometriosis of the American Society of Reproductive Medicine, participated in this study. The patients were between 24 and 32 years of age, with a body mass index not greater than 29 kg/m2. They were also free from diabetes, impaired sensation, gynecological hemorrhage, and tubo-ovarian abscesses. All participants signed informed consent forms agreeing to participate and to the publication of the results of the study. All participants received the usual regimen of hormonal treatment for endometriosis (100 mg medroxyprogesterone acetate every 2 weeks for 1 month, then once monthly). No physical therapies were given while the study was in progress. The research committee of the Physical Therapy Department, Faculty of Applied Medical Sciences in Umm Al-Qura University, Makkah, Saudi Arabia approved the study.
Randomization
Patients were randomly assigned into two groups, group I (HILT group) and group II (control group), using a simple random sample technique. Group I patients received pulsed HILT three times per week for 8 weeks, while those in group II received sham laser at the same frequency for the same time period. Before the intervention, one assessor (a physician) blinded to the study outcome evaluated the clinical assessment parameters, while another assessor (a physician) evaluated the outcome measures after the intervention. Both assessors were not aware of the prescription of interventions, the primary investigator was aware of the intervention and implemented it to the patients, so that the patients and the assessors were blinded, while the therapist was not.
Laser protocol
Group I participants HILT via a pulsed Nd:YAG laser from a HIRO 3 device (ASA, Vicenza, Italy). The apparatus used postulates (Nd:YAG), with pulsed emission (1064 nm), a peak power of 3 kW, energy density fluency from 810 to 1780 mJ/cm2, a 120–150 μs pulse duration, and a duty cycle of 0.1%, with a frequency of 10–40 Hz. The total average energy of the HILT application was 1300 J administered in three phases, with the patient lying supine in a comfortable and relaxed position supported by small cushions under their knees, back, and neck accommodating body curvature. In the first phase, laser fluency was 510 mJ/cm2 for an average total energy of 500 J, including fast scanning for the suprapubic area and the left and right iliac fossa. The intermediate phase was applied using a headpiece to 15 points, of which 5 were in the suprapubic area and 10 were over the iliac fossa region on each side with 20 J, a fluency of 610 mJ/cm2, and 14 sec at each point, with a total applied energy applied of 300 J. The last phase was identical to the first phase, except that scanning was slower and the total application time was ∼20 min. Table 1 shows all parameters of HILT that were applied in this study.
Outcome measures
Participants were quizzed on the severity of pain using present pain intensity (PPi), 28 a graphic rating scale in which numerical values are at equal distances along a line where 0 represents no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 describes an unbearable level of pain. For both groups, this was performed before and after the course of treatment. The pain relief (PR) scale 28 was also used after the course of treatment to indicate how much PR had been experienced. PR operates in a way similar to PPi, in that, 0 represents no relief, 1 is slight relief, 2 is good relief, 3 is excellent relief, and 4 describes complete relief.
Laparoscopy was performed by a gynecologist to determine the degree of endometriosis in accordance with the American Society for Reproductive Medicine score 10 for all patients in both groups, before the course of treatment began and at its end. Quality of life was evaluated using the Endometriosis Health Profile (EHP-5), 29 a valid instrument for that purpose. It contains 11 markers, 5 indicate difficulty in walking, lack of control or being powerless, mood swings, lack of social support, and self-image all from the core questionnaire. The other six are taken from the modular questionnaire and may not be applicable to every woman suffering from endometriosis. They include difficulties with work, difficulties with intercourse, worries about infertility, worries about treatment, relationships with children, and relationships with medical professionals. Each item is ranked using a five-point scale, with never = 0, rarely = 1, sometimes = 2, often = 3, and always = 4. There is also the option to mark an indicator as not relevant. 30
Data analysis
Data analysis was performed using IBM SPSS version 19.0 (IBM Corp, Armonk, NY). Frequencies and improvement percentages were also reported. In addition, mean, standard deviation (SD), and mean difference (MD) were also reported. The Wilcoxon test was performed for two related samples and the Mann–Whitney test for two independent samples. The results were considered statistically significant when p < 0.05.
Results
Pain severity
PPi scale
As shown in Table 2, before the course of treatment began, most HILT group members felt severe pain or unbearable pain (90%). This was significantly (p < 0.001) reduced after treatment, with the majority of participants reporting no or mild pain (85%). In the control group, the results before beginning treatment were very close to those in the HILT group. After treatment was completed, many participants complained of moderate or severe pain (75%).
Significant p < 0.05.
HILT, high-intensity laser therapy; N, number of patients; Tx, treatment.
Present relief scale
Many participants (85%) in the HILT group experienced complete or excellent relief after the treatment course as shown in Table 3, while in the control group, complete and excellent relief were only reported by four participants (20%). The posttreatment mean values of PR were significantly (p < 0.0001) different between the two groups.
Significant p < 0.05.
Degree of endometriosis as assessed by adhesion score
Before treatment, more than half of the HILT group suffered from moderate endometriosis (60%) as shown in Table 4, but all participants were found to have minimal or mild endometriosis, with no cases of moderate endometriosis, after treatment. In the control group, 65% of the cases suffered from moderate endometriosis before treatment, with nearly half of the cases (55%) found to have minimal endometriosis or mild endometriosis after treatment. In addition, the posttreatment mean adhesion scores were significantly (p < 0.0001) different between groups.
Significant p < 0.05.
Quality of life
Table 5 shows a comparison of the level of quality of life between the groups. After treatment, the HILT group had a better quality of life in comparison with the control group as evidenced by higher scores in all five domains of EHP-5 and a significant difference in the mean value of quality-of-life scores.
Significant p < 0.05.
Discussion
The purpose of this study was to determine the effectiveness of pulsed HILT in alleviating pain and reducing adhesions in women suffering from endometriosis. The study results showed that the HILT group experienced a statistically significant decrease in severity of pain and adhesions, with a highly statistically significant improvement in their quality of life (p < 0.0001). Numerous studies have found HILT to be more effective than low-level laser therapy (LLLT), which has been attributed to HILT's higher intensity and the greater depth reached by the laser. 26 It should also be noted that the laser's effectiveness relies on specific factors, including wavelength, locus, duration, dose, and target tissue depth. Earlier research suggests that the ability to penetrate human skin is dependent on wavelength, 31,32 but there have been no studies that investigated how HILT affected the treatment of women suffering from endometriosis.
HILT's sedative action may result from a number of mechanisms that involve its capacity to decrease conduction of pain impulses and to raise the rate of production of substances in human tissue that mimic the action of morphine. 26 It may also be able to block the transmission of pain through Aδ- and C-fiber, increasing blood flow, vascular permeability, and cell metabolism. 33 There is a paucity of literature on the use of HILT as an intervention compared with LILT, and a few studies have discussed HILT use in the management of several musculoskeletal disorders such as knee osteoarthritis, 34,35 low-back pain, 36,37 cervical spondylosis, 38 neck pain, 39 subacromial impingement syndrome (SAIS), 40 and osteoporosis. 41 Although there is limited evidence about the effectiveness of HILT in diseases affecting, very few studies have been conducted. A recent randomized clinical trial investigated the efficacy of HILT versus pulsed electromagnetic field (PEMF) in the management of primary dysmenorrhea, finding that both interventions were effective, but HILT induced a more significant decrease in pain and prostaglandin levels than PEMF. 42 In the current study, HILT also showed a significant improvement (p < 0.0001) compared with sham laser treatment in women with endometriosis in terms of PR, decreasing the adhesions and improving the quality of life. However, the current study provided a different comparison group from the above study and used a different laser protocol based on the type of patients, which may influence the generalization of the results.
This study's results are consistent with those of Kheshie et al., 34 who found that HILT was more effective than LILT in the management of people with knee osteoarthritis. The authors concluded that HILT combined with exercise was more effective than LLLT with exercise on pain reduction and functional improvement. Furthermore, other studies have reported that HILT was more effective than some forms of physiotherapy modalities. According to Santamato et al., 40 HILT was more effective than therapeutic ultrasound in treating patients with SAIS after 10 treatment sessions in the following outcomes: pain, shoulder movement, function, and muscle strength. However, this study did not include a control or a placebo group, had no follow-up period, and the intervention period was only 2 consecutive weeks which may limit the generalization of study results. Another study compared HILT and traction therapy with the Saunders device in the treatment of cervical spondylosis. 38 The results showed that both interventions demonstrated analgesic efficacy and had similar effect immediately after the treatment and after 4 weeks in pain and disability improvement, but after 12 weeks, HILT significantly maintained the beneficial therapeutic effects in comparison to traction.
The current study also supports the findings of Alayat et al., 36 who investigated the effect of HILT in the management of chronic low-back pain. The authors concluded that HILT combined with exercise demonstrated a greater benefit to patients with chronic low back pain (CLBP) than HLLT alone or placebo laser with exercise with regard to the lumbar range of motion (ROM), pain, and disability. Moreover, HILT was significantly superior compared to placebo laser in the treatment of chronic neck pain in terms of cervical ROM, pain, and functional activity after 6 weeks of treatment. 39 However, both these studies included only male participants, which may limit their results only to a male population.
The present findings agree with Bjordal et al., 43 who described laser treatment as effective for acute pain and bringing about short-term pain reduction by reducing inflammation. They also support the findings of Soliman et al. 44 that LLLT and reflexology could significantly improve ROM and reduce the severity of pain in diabetic patients with adhesive capsulitis. Therefore both therapies may be recommended to treat a frozen shoulder until more data have been obtained on their individual effectiveness. Furthermore, Teixeira et al. 45 reported that LLLT treatment prevents intra-abdominal adhesions with no compromise to the abdominal wall's strength or healing.
This study's results are also consistent with those of Hwang et al., 46 who found that LLLT has the ability to significantly suppress an inflammatory (macrophage-conditioned medium induced) response in annulus fibrosus cells in a manner dependent on both time and wavelength. They concluded that LLLT has potential in anti-inflammatory therapy for patients suffering from painful disc degeneration. In addition, Jin et al. 47 reported that laser therapy was effective and safe in managing hypertrophic scars.
A meta-analysis reported that laser therapy has a positive effect on wound tensile strength, reducing the size, healing time, and total collagen content of wounds, resulting in an overall treatment effect size ≥2.22; this meta-analysis showed the largest average effect size to be derived from energy densities between 19 and 24 J/cm2. 48 Another meta-analysis on the effect of laser therapy on tissue repair in clinical cases showed a positive effect described as small to moderate, with an overall mean effect size being +0.34 [95% confidence interval (CI) = −0.25 to 0.94]. 49 All these findings support the hypothesis that suitable laser therapy is effective for both pain and function, and that a broad range of parameters are effective in laser therapy.
Conclusions
In conclusion, HILT is effective in treating and reducing endometriosis symptoms and in improving patients' quality of life. It is suitable for use as an alternative conservative therapy to current medications, which are associated with numerous side effects.
Footnotes
Acknowledgments
Many thanks to Dr. Sameh Baz who performed the laparoscopy diagnosis and referred the patients from gynecology departments of Makkah hospitals. We also take the opportunity to thank all patients who participated in this study.
Author Disclosure Statement
No competing financial interests exist.
