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Department of Nursing, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanSchool of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanGraduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, TaiwanFooyin University College of Nursing, Kaohsiung, Taiwan
Address correspondence to Chun-Ting Liu, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Rd., Niaosong Dist., Kaohsiung 83301, Taiwan.
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanGraduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan
Laser acupuncture is a safe, non-invasive, and painless nonpharmacologic technique.
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Laser acupuncture improves the postpartum low back pain.
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Laser acupuncture diminishes the limitations of daily activity and physical activity, and perceived stress in women with postpartum low back pain.
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Laser acupuncture could be used as an alternative therapy for postpartum low back pain in the postpartum care setting.
Abstract
Background
Unresolved postpartum LBP may affect women...s physical and psychological health.
Aim
To investigate the analgesic effects of laser acupuncture therapy (LAT) for postpartum LBP.
Method
Postpartum women with LBP were recruited and randomly assigned to the intervention group or the control group from November 2017 to July 2018. The participants in the intervention group received LAT and standard care. The participants in the control group received only standard care. The primary outcome was the Visual Analogue Scale for LBP. Secondary outcomes were limitation of daily activities and physical activity; perceived stress scale; and salivary cortisol values.
Results
In all, 106 participants were recruited and assigned to the intervention group or the control group. As compared with the control group, the participants in the LAT group had significantly lower intensity of LBP (mean ± SD: 1.21 ± 0.99 vs 3.25 ± 1.14; p < .001), limitations of daily activities (mean ± SD: 3.17 ± 2.09 vs 10.40 ± 4.72; p < .001) and physical activity (mean ± SD: 3.04 ± 2.17 vs 9.79 ± 4.71; p < .001), perceived stress (mean ± SD: 26.13 ± 3.97 vs 28.85 ± 4.26; p = .001), and salivary cortisol levels (mean ± SD: 0.194 ± 0.131 vs 0.280 ± 0.234; p = .02) post-intervention.
Conclusions
For postpartum LBP, LAT combined with standard care had greater analgesic efficacy, lower perceived stress, lower limitations of daily activities and physical activity, and lower salivary cortisol levels than standard care alone.
The reported prevalence rate of postpartum low back pain (LBP) is 52% (
Risk of chronic low back pain among parturients who undergo cesarean delivery with neuraxial anesthesia: A nationwide population-based retrospective cohort study.
). The risk factors for postpartum LBP include the presence of back pain during pregnancy, multiparous pregnancy, heavy physical work, and epidural or spinal anesthesia for labor or cesarean section (
Risk of chronic low back pain among parturients who undergo cesarean delivery with neuraxial anesthesia: A nationwide population-based retrospective cohort study.
). In addition, infant care activities such as frequently lifting and carrying the baby or faulty posture without any propping while breastfeeding also could lead to postpartum LBP (
). Despite its interference with physical activity and daily living demands, including taking care of their babies, women often view LBP as a normal part of postpartum adaptation (
). Unresolved LBP, however, can negatively affect women's psychological health and consequently their ability to carry out their maternal roles after delivery (
). Most women experience pain and fatigue immediately after giving birth. They also experience changes in body shape and discomfort from episiotomy and breast engorgement. Additionally, the postpartum woman must establish a relationship with her infant(s). In the postpartum period, the woman learns to understand her infant's unique patterns of crying, sleeping, feeding, and other behaviors (
). If she cannot soothe her infant, she may view herself as a failure, which may also lead to psychologic stress. The physiologic and psychologic stress can activate the hypothalamus-pituitary-adrenal axis (HPAA) to release cortisol; consequently, the released cortisol enhances the breakdown of glycogen and body fat into energy and modulates inflammation to adapt to the stress (
). However, prolonged or exaggerated stress from unresolved LBP may cause cortisol dysfunction, such as cortisol depletion and glucocorticoid receptor resistance or down-regulation, followed by widespread inflammation and pain.
In traditional Chinese culture, postpartum confinement, a special practice known as “Tso Yueh-tzu” (“doing the month”) in Chinese, is a system of recovery involving rest and special foods for women after delivery lasting approximately one month. Traditionally, postpartum women are confined so as to ensure that they get complete rest; stay indoors; avoid exposure to wind or cold air; avoid washing their hair or taking a bath; eat warm food; avoid consuming cold water, vegetables, and fruits; and abstain from sexual intercourse (
). Taiwan has experienced a number of social and economic changes in recent decades. More and more young couples have migrated to urban areas and live independently. Now the position of women in modern Taiwan society has been greatly improved. Modern Taiwanese women have increased access to higher education, more opportunity for working outside the home, and more opportunity to contribute to decision-making in the family. These changes to traditional family structure in contemporary Taiwan make it difficult for women to fully embrace the ritual practices of “Tso Yueh-tzu” (
). In modern times, most postpartum women in Taiwan engage in this traditional practice at postpartum care centers rather than at home. Many postpartum care centers claim to offer traditional beliefs and modern health care in a modern facility, aiming to incorporate the traditional ritual practices of “Tso Yueh-tzu” into their modern lifestyle. Doctors and nurses in postpartum care centers provide care to the women and their babies for about 1 month. Because of contemporary scientific knowledge and modern facilities such as hair dryers and air conditioning, modifications to the traditional practice, such as taking baths, washing their hair, and eating vegetables and fruits, are no longer forbidden (
). After delivery, women in many East Asian countries mainly use complementary and alternative medicine (CAM), particularly noninvasive and nonpharmacologic strategies such as acupressure and massage, for pain relief and relaxation (
). According to the clinical practice guidelines from the American College of Physicians, nonpharmacologic treatments such as superficial heat, rehabilitation, acupuncture, massage, and low-level laser therapy should be initially used for the treatment of chronic LBP (
Clinical Guidelines Committee of the American College of Physicians Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians.
). The mechanism underlying the pain relief provided by stimulating acupuncture points is not fully understood. It may be that acupuncture stimulates somatic nerves, the autonomic nervous system, and the endocrine system, such that the body heals itself (
). Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity and non-thermal laser irradiation. LAT has become a common practice among acupuncture practitioners in recent years because of its minimal sensation, short duration of treatment, and minimal risks of infection, trauma, and bleeding complications (
). The mechanisms of LAT may include inducing peripheral neural blockade, suppressing central synaptic activity, modulating neurotransmitters, and reducing muscle spasm (
To our knowledge, no studies have examined the analgesic effects of laser acupuncture on postpartum LBP. Therefore, in this study, we aimed to investigate the analgesic efficacy of adjuvant LAT in reducing LBP among postpartum women. We hypothesized that adjuvant LAT would be more effective than standard postpartum care alone in reducing LBP, which in turn would reduce stress and improve daily activities.
Methods
Study Design
This study was a single-center, prospective, parallel randomized controlled trial conducted from November 2017 to July 2018 at Kaohsiung Chang Gung Memorial Hospital (KCGMH), a 2,600-bed tertiary medical center. The study protocol was reviewed and approved by the Institutional Review Board of the Chang Gung Medical Foundation (IRB no. 201700427B0C601). The postpartum women were recruited via poster advertising on the first day of admission to a postpartum care center. The nursing staff initially screened the postpartum women for inclusion criteria and asked them if they would like to join the study. A total of 114 postpartum women were contacted and assessed for eligibility by the study team. The recruited participants (n = 106) who met the inclusion criteria were randomly assigned to the intervention group (LAT plus standard postpartum care, n = 53) or the control group (standard postpartum care alone, n = 53). The study design based on the CONSORT 2010 is depicted in Figure 1. All participants provided written informed consent.
Postpartum women aged 20 years or older were contacted and assessed for the eligibility to participate in the study by research staff in the postpartum care center. LBP was defined as pain self-reported by postpartum women, located in the lumbar area between the twelfth rib and the gluteal fold, and characterized as a dull pain (
). The inclusion criteria were that the postpartum women had LBP with a visual analogue scale (VAS) score ≥1 and that the LBP was not relieved by rest for 30 minutes. The exclusion criteria were systemic diseases, cancers, psychiatric diseases, or treatment for severe pain by a physician. Written informed consents were obtained from all participants before randomization. All participants with postpartum LBP received standard postpartum care from the time of admission, provided by nursing staff who had no information about the group allocations.
Sample size calculation
No appropriate previous studies or preliminary data were available for the estimate of sample size. Under the assumptions of a power of 80% (1-β = 0.80), statistical significance (α = 0.05) of 95%, a medium effect size (d = 0.5), and a dropout rate of 5%, a total of 53 participants in each group was required in this trial, as determined with G Power software (G*Power 3.1.9.2, Heinrich-Heine-Universität-Düsseldorf, Germany).
Randomization and Blinding
All participants were informed that they would be randomly assigned to one of two intervention protocols for LBP. The participants were not notified about their group allocations before randomization or the intervention protocol that would be applied as a control. Randomization was conducted using block randomization with two treatment groups and a block size of 2 by computer-generated randomized sequencing. The randomization procedure was performed by an independent researcher who was not involved in the recruitment, treatment, or assessment procedures. All participants received standard postpartum care provided by their nurses, and participants in the LAT group received adjuvant LAT performed by a certified traditional Chinese medicine (TCM) doctor. The nursing staff and the TCM doctor were not involved in the outcome assessment. The outcomes were assessed by an investigator who was blinded to the treatment allocation.
Intervention
Control group/Standard postpartum care
The standard postpartum care in this study was based on modern scientific knowledge rather than traditional practices. All participants maintained modern standards of hygiene and were encouraged to eat a well-balanced diet from all food categories. In addition, the standard postpartum care contained full assessments of physical, social, and psychological well-being, including: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance. Standard postpartum care provides an opportunity for a mother to ask questions about her labor, childbirth, and any complications. To prevent deterioration and reduce the severity of LBP, nursing staff explained the causes of LBP to participants and educated them on correct posture during baby care activities. The participants were referred to a specialist if their VAS scores for pain exceeded 7. The participants in control group did not receive LAT after the study.
In addition to the standard postpartum care, the participants in the LAT group underwent 10 sessions of daily LAT in the morning for 2 weeks, except on weekends. The LAT was applied with a gallium aluminum arsenide Laser Pen (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany; B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz). The participants in the LAT group chose a comfortable position, lying on their left or right sides in the bed in the patient's room, and received 0.375 J of energy at each of the following acupoints bilaterally (Fig. 2): BL23 (Shenshu, B2), BL25 (Dachangshu, B2), BL26 (Guanyuanshu, B2), BL40 (Weizhong, B2), and SP6 (Sanyinjiao, B2). The laser treatment was applied to each point for 5 seconds, for a total treatment dose of 4.5 J/cm2. These acupoints are mainly located on the lower back and lower leg. All acupoints were selected and localized according to the World Health Organization (WHO) Standardized Acupuncture Point Location guidelines (
). The selected acupoints were based on TCM theory. BL23, BL25, and BL26, located on the lower back, are used to produce local analgesic effects. According to TCM theory, BL40 is a principle acupoint for treating LBP, and SP6 is a principle acupoint for treating diseases and promoting health in women. To ensure the consistency and quality of the LAT, each LAT session was performed by the same Chinese medicine practitioner, who had more than 10 years of experience in acupuncture and Chinese medicine.
Figure 2Acupoints used in the study: BL23, BL25, BL26, BL40, SP6.
The primary outcome was subjective intensity of LBP. Secondary outcomes were limitations of daily and physical activity, perceived stress, and salivary cortisol values as an objective biomarker. The outcomes were measured at baseline and after the completion of the intervention at 2 weeks after the baseline.
Low back pain intensity
The subjective intensity of LBP was measured using scores on a 0 to 10 cm VAS with anchor points of 0 (no pain) to 10 (worst possible pain). Participants pointed to a specific anchor point to show the intensity of their pain. A higher score indicated a higher intensity of LBP.
Limitations of daily activities and physical activity
Many postpartum women decrease their physical activity and daily activities because of LBP. In 1998, the International Program on Primary Care of Back Pain proposed a standardized outcome measurement questionnaire for LBP studies in order to facilitate data interpretation. The questionnaire contains the Roland-Morris Disability Questionnaire (RMDQ) for daily activities and the modified version of the Oswestry Disability Questionnaire for physical activities (
). The Chinese version of the RMDQ contains 24 dichotomously scored items to evaluate the effect of back pain on daily activities. If respondents check “yes” on a question, a score of 1 is given, indicating an effect on daily activities or function. Conversely, if respondents check “No”, a score of 0 is assigned, indicating no effect on daily activities or function. The total score ranges from 0 to 24, with higher scores indicating a higher level of limitation of daily activities. The Chinese version of the RMDQ has good reliability and validity, as indicated by a Cronbach's alpha of 0.85 (
Chinese Translation and Adaptation of the Roland-Morris Low Back Pain Disability Questionnaire [Chinese Translation and Adaptation of the Roland-Morris Low Back Pain Disability Questionnaire].
Formosan Journal of Physical Therapy.2003; 28: 324-332
). The limitation of physical activity was scored on the Chinese version of the Oswestry Disability Index (ODI) version 2.1. The ODI includes 1 item on pain and 9 items on physical activities of daily living (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is rated on a scale of 0 (able to perform) to 5 (unable to perform). In this study, items 8 (sex life) and 10 (travelling) were omitted because of the conflict with the cultural practice of postpartum confinement in Taiwan. Postpartum women in Taiwan are unlikely to engage in sexual behavior or travel outside their homes for 4 to 6 weeks after childbirth. The total score of the ODI ranges from 0 to 40, with higher scores indicating greater limitation of physical activities. The Chinese version of the ODI version 2.1 has good reliability and validity, with a Cronbach's alpha of 0.90 (
), which is used to assess the degrees to which situations in one's life can be considered stressful. The PSS was translated into a Chinese version, which was reported to be reliable in a previous study by Leung et al. (
). The PSS contains 7 items with positive subscales and 7 items with negative subscales. Each item is rated from 0 to 4 (0 = never, 4 = very often). In this study, we reversed the scores on the seven positive items and then summed the scores across all 14 items so that higher scores indicated higher levels of perceived stress.
Salivary cortisol
Our study used salivary cortisol values as an objective biomarker of physiologic and psychologic stress associated with pain (
). The salivary cortisol was collected by having participants spit saliva into a collection cup in the morning before brushing their teeth or breaking their nocturnal fast. After collection, salivary samples were kept cold to prevent bacterial growth in the specimen. The samples were immediately refrigerated at 4°C and, within 4 hours of collection, stored at -20°C until analysis. The salivary cortisol values were determined by Salimetrics® Cortisol Enzyme Immunoassay Kit (Item No. 1-3002, Salimetrics LLC, State College, PA) according to the manufacturer's instructions.
Statistical Analyses
All analyses were performed in SPSS 22.0 for Windows (Statistics 22.0, SPSS, IBM, New York, NY). For demographic characteristics, the categorical and quantitative variables were compared using the chi-square test and independent t test, respectively. The outcomes, including the VAS, RMDQ, ODI, and PSS scores and the salivary cortisol levels, were compared between the two groups by independent t test. A paired t test was performed to compare differences in VAS, RMDQ, ODI, and PSS scores and salivary cortisol levels before and after intervention in each group. Analysis of covariance (ANCOVA) was used to compare the post-intervention scores between the two groups after adjustment for their respective baseline levels. Differences with p values of less than .05 were considered statistically significant in all analyses.
Data Monitoring
No data monitoring committee (DMC) was needed because laser acupuncture is a general practice and noninvasive intervention. However, all participants were instructed to report any adverse events to the research staff at each study visit. Adverse events after the intervention, such as transient dizziness, headaches, and fatigue, were recorded throughout the trial.
Results
A total of 106 participants were recruited and randomly assigned to the LAT group (n = 53) and the control group (n = 53). The flowchart is shown in Figure 1. All participants in the LAT group completed the 2-week intervention. In the control group, one participant was withdrawn by the study team because of severe mastitis and the resultant determination of unsuitability to continue this study. Their mean age was 33.6 years (SD = 4.30 years). Sixty-one (58.1%) women were primipara and 44 (41.9%) women were multipara. Detailed characteristics are shown in Table 1. There were no significant differences in demographic and obstetrics characteristics between the two groups. The results of the outcome measurements are presented in Table 2.
Table 1Demographic and Obstetrics Characteristics of the Participants
Variables
Total (n=105)
LAT group (n=53)
Control group (n=52)
p
M ± SD or n (%)
M ± SD or n (%)
M ± SD or n (%)
Continuous variables
Age
33.6 ± 4.30
34.3 ± 3.71
32.8 ± 4.75
.08
BMI (kg/m2)
24.4 ± 2.97
23.9 ± 2.45
25.0 ± 3.37
.07
Category variables
Education level
.42
Senior high school
14 (13.3)
7 (13.2)
7 (13.5)
College
65 (61.9)
30 (56.6)
35 (67.3)
Master and above
26 (24.8)
16 (30.2)
10 (19.2)
Delivery type
.13
Vaginal delivery
70 (66.7)
39 (73.6)
31 (59.6)
Caesarean
35 (33.3)
14 (26.6)
21 (40.4)
Obstetrical analgesia
.08
No analgesia
54 (51.4)
25 (47.2)
29 (55.8)
Spinal
37 (35.4)
17 (32.1)
20 (38.5)
Epidural
14 (13.3)
11 (20.8)
3 (5.8)
Parity
.27
Primipara
61 (58.1)
28 (52.8)
33 (63.5)
Multipara
44 (41.9)
25 (47.2)
19 (36.5)
Feeding status
Breastfeeding
47 (44.8)
22 (41.5)
25 (48.1)
.50
Mixed feeding
58 (55.2)
31 (58.5)
27 (51.9)
Comparisons were conducted using chi-square analysis for categorical variables and t tests for continuous variables. LAT = laser acupuncture therapy; M = mean; SD = standard deviation; BMI = body mass index.
p values: compared LAT group and control group using independent t-test. F for ANCOVA: compared post-intervention scores between two groups after adjusting for their respective baseline levels
LAT = laser acupuncture therapy; M = mean; SD = standard deviation; VAS = visual analogue scale; RMDQ = Roland Morris Disability Questionnaire; ODI = Oswestry Disability Index; PSS = Perceived Stress Scale.
a p values: compared LAT group and control group using independent t-test. F for ANCOVA: compared post-intervention scores between two groups after adjusting for their respective baseline levels
b p < .001.
c p < .001, compared with baseline using paired t test.
d p < .05, compared with baseline using paired t test.
e p < .01, compared with baseline using paired t test.
After the intervention, the VAS scores were statistically lower than the baseline scores in both groups (both, p < .001). VAS scores post intervention were significantly lower in the LAT group than in the control group (mean ± SD; 1.21 ± 0.99 and 3.25 ± 1.14, respectively, p < .001), indicating that participants in the LAT group had a lower intensity of LBP than that of the control group. We used ANCOVA to compare post-intervention scores after adjusting the baseline pain scores of the two groups, and the difference remained statistically significant (F = 144.63, p < .001) (Table 2).
Secondary Outcomes
The RMDQ score of the LAT group was statistically lower than the baseline after intervention (p < .001); however, it was higher in the control group. Comparison of the ANCOVAs between the two groups indicated a significant difference in RMDQ (F = 149.16, p < .001). This difference suggested that the limitation of daily activities was lower in the LAT group than in the control group (Table 2).
ODI scores in the LAT and control groups were statistically lower than the baseline scores after intervention (p < .001 and p < .05, respectively). ODI scores post intervention were significantly lower in the LAT group than in the control group (mean ± SD; 3.04 ± 2.17 and 9.79 ± 4.71, respectively, p < .001). Comparison of ANCOVAs with baseline levels adjusted also showed a significant difference between the two groups (F = 171.87, p < .001), indicating that levels of limitation of physical activity were lower in the LAT group than in the control group (Table 2).
PSS scores in the LAT group were statistically lower than baseline scores after intervention (p < .01); however, they were statistically higher in the control group (p < .05) after intervention. Comparison of ANCOVAs with baseline levels adjusted showed a significant difference between the two groups (F = 14.75, p < .001), indicating that perceived stress was lower in the LAT group than in the control group (Table 2).
The morning salivary cortisol values in the LAT and control groups had no significant changes from baseline to the end of the intervention (p = .73 and .24, respectively). However, after the intervention, the mean value of change in salivary cortisol decreased in the LAT group (mean ± SD; 0.194 ± 0.131) and increased in the control group (mean ± SD; 0.280 ± 0.234) as compared with the baseline data. The salivary cortisol values post-intervention were significantly lower in the LAT group than in the control group (mean ± SD; 0.194 ± 0.131 and 0.280 ± 0.234, respectively, p = .02). Comparison of ANCOVAs between the two groups also showed a significant difference in salivary cortisol after adjustment of their baseline scores (F = 5.47, p < .05) (Table 2).
Adverse Events
Typically, patients do not feel any sensation while receiving LAT; however, some participants reported a tingling or light touch sensation, which was considered normal. No adverse events after intervention, such as transient dizziness, headaches, and fatigue, were reported during the trial.
Discussion
This report presents the first randomized controlled study of LAT for postpartum LBP. The data showed that the subjective pain intensity and biomarker salivary cortisol level were significantly lower in the LAT group than in the control group, suggesting that adjuvant LAT had greater analgesic efficacy for postpartum LBP than did standard postpartum care alone. The result was consistent with a previous study on chronic LBP (
) reporting that adjuvant LAT provides more beneficial effects than does exercise alone. Furthermore, according to a previous meta-analysis study, clinically meaningful pain reduction can be achieved with low-level laser therapy, and the pain relief can persist up to 12 weeks post-completion of treatment, especially with a higher laser dosage (
Postpartum care is very important to a mother's well-being. Postpartum women's recovery from birth can be assisted through increased physical activity. However, unresolved postpartum LBP can reduce women's daily physical activities and increase their perceived stress. In our study, the RMDQ and ODI scores were significantly lower in the participants receiving adjuvant LAT than in those receiving standard postpartum care alone. These findings suggest that adjuvant LAT is more beneficial than standard postpartum care alone in reducing the limitation of daily activities and physical activity of postpartum women. They also imply that the positive effect of LAT on reducing limitations of daily activities and physical activity could be ascribed to the greater amelioration of LBP. In addition, the scores on the PSS post intervention were lower in the LAT group than in the control group, suggesting that LAT has the potential to directly improve postpartum psychological conditions or to indirectly do so through reduction of pain severity. Better pain control and consequent improvement of physical activity may simultaneously help postpartum women to care for their babies and adjust to postpartum stress.
In addition to the subjective pain intensity measurement, salivary cortisol values were also measured as an objective biomarker of stress associated with pain so as to investigate the effect of LAT. This measurement was chosen for its advantages of being easy to perform, non-invasive, and strongly correlated with free cortisol measured in plasma and serum (
). Cortisol is often called the "stress hormone" because of its connection to the stress response. The authors propose that higher postpartum LBP and postpartum-related stress could activate HPAA to release more cortisol in response to pain and stress. The study results indicated that salivary cortisol values were significantly lower in the LAT group than in the control group during the postpartum period, which suggested that adjuvant LAT may reduce the HPAA-related stress response from postpartum LBP by reducing the level of cortisol more than standard postpartum care alone does. Moreover, none of the participants reported adverse reactions or side effects during the periods of LAT in the study. The study results showed that 10 sessions of LAT can significantly reduce the pain intensity and physical functional status in postpartum women with LBP within 1 month after childbirth. However, further research is needed to investigate the long-term effects of LAT on postpartum LBP.
Limitations
This study had some limitations. First, the study was conducted at a single postpartum care center in southern Taiwan. The specificity of the population may reduce the generalizability of this trial. Future studies could recruit study participants from more postpartum care centers in different areas or include participants of different ethnicities or nationalities. Second, the study did not use a sham-LAT control group under the consideration of the highest standards of ethical conduct. Another reason is that, despite the intervention for postpartum LBP being free of charge, the medical expenses in postpartum care centers must be paid by the patient herself; the National Health Insurance of Taiwan provides no reimbursement for such care. Thus, the concept of the study design was to allow participants to receive treatment for LBP regardless of group assignment. The participants did not know which group was the control group or what the differences between the two intervention protocols in the study were because the women in the postpartum care center were all housed in single-occupancy wards and received treatment separately. Therefore, despite the absence of a sham-LAT control group, the authors believe that such a design could be accepted by the patients relatively easily and had little effect on the research results.
Conclusions
In women with postpartum LBP, LAT combined with standard postpartum care led to significant reductions in pain intensity, perceived stress, limitations of daily activities and physical activity, and salivary cortisol levels than did standard postpartum care alone. LAT is a safe and feasible intervention as an adjuvant therapy for women with postpartum LBP in the postpartum care setting.
Conflict of interest
The author(s) declare that they have no conflict of interests.
Acknowledgements
The authors gratefully acknowledge all the postpartum women who participated in this research for their cooperation.
This study was supported by the Chang Gung Memorial Hospital research grant: (Grant No: CMRPG8G0941, CPRPG8G0161, and CPRPG8G0162).
The Clinical Trial Registry identifier on ClinicalTrials.gov. was NCT04238117. This protocol had been reviewed and approved by the Institutional Review Board of the Chang Gung Medical Foundation (IRB no. 201700427B0C601).
References
Chen S.M.
Liu M.F.
Wang B.M.
Huang M.H.
Chinese Translation and Adaptation of the Roland-Morris Low Back Pain Disability Questionnaire [Chinese Translation and Adaptation of the Roland-Morris Low Back Pain Disability Questionnaire].
Formosan Journal of Physical Therapy.2003; 28: 324-332
Risk of chronic low back pain among parturients who undergo cesarean delivery with neuraxial anesthesia: A nationwide population-based retrospective cohort study.
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