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Linköping University Post Print Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial Annelie Gutke, Jenny Sjödahl and

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Linköping University Post Print Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial Annelie Gutke, Jenny Sjödahl and Birgitta Öberg N.B.: When citing this work, cite the original article. Original Publication: Annelie Gutke, Jenny Sjödahl and Birgitta Öberg, Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial, 2010, Journal of Rehabilitation Medicine, (42), 10, Copyright: Foundation for Rehabilitation Information Postprint available at: Linköping University Electronic Press Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial Annelie Gutke, PhD, Jenny Sjödahl, RPT, Birgitta Öberg, PhD Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, SE Linköping, Sweden Short title: Stabilizing exercises as home training Abstract Objective: To investigate the efficacy of home-based specific stabilizing exercises focusing on the local stabilizing muscles as the only intervention in the treatment of persistent postpartum pelvic girdle pain (PGP). Design: A prospective, randomized, single-blinded, clinically controlled study. Subjects: Eighty-eight women with pelvic girdle pain were recruited 3 months after delivery. Methods: The treatment consisted of specific stabilizing exercises targeting the local trunk muscles. The reference group had a single telephone contact with a physiotherapist. Primary outcome was disability measured with Oswestry Disability Index. Secondary outcomes were pain, health-related quality of life (EQ-5D), symptom satisfaction, and muscle function. Results: No significant differences between groups could be found at 3- or 6-month follow-up regarding primary outcome in disability. Within-group comparisons showed some improvement in both groups in terms of disability, pain, symptom satisfaction and muscle function compared with baseline although the majority still experienced pelvic girdle pain. Conclusion: Treatment with this home-training concept of specific stabilizing exercises targeting the local muscles was no more effective in improving consequences of persistent postpartum pelvic girdle pain than the clinically natural course. Regardless of whether treatment with specific stabilizing exercises was carried out, the majority of women still experienced some back pain almost one year after pregnancy. Journal of Rehabilitation Medicine; Annelie Gutke; Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, SE Linköping, Sweden; Key words: low back pain; postpartum; physical therapy; exercise therapy, pelvic floor; specific stabilizing exercises; trunk muscles. Introduction Approximately 50% of all pregnant women experience lumbopelvic pain to some degree during pregnancy (1). For the majority of women, this pain disappears within 3 months after delivery (2). However, the pain is persistent postpartum for a substantial number of women (3, 4) and in 7% the pain is severe (1). Of women with recurrent lumbopelvic pain, 10 to 20% relate their first episode of pain to pregnancy (5, 6). Research aiming to identify effective and early treatment strategies for persistent pregnancy-related lumbopelvic pain is important. Recent studies demonstrated the importance of subgrouping lumbopelvic pain (7-9). In this study we have chosen to focus on the subgroup with pelvic girdle pain (PGP) (10) or PGP in combination with lumbar pain (combined pain) since these groups were shown to have the highest impact on daily life (9). Dysfunction of load transfer in the lumbopelvic region has been raised as one possible explanation to lumbopelvic pain (11). A theoretical model of lumbopelvic pain presents a self-locking mechanism of the pelvic joints based on the principles of form closure and force closure (12). The local stabilizing muscles, i.e. the transversely oriented abdominal, the lumbar multifidus, and the pelvic floor muscles, are reported to play an important role in load transfer in the lumbopelvic region (13-15). Likewise muscle dysfunction has been associated with PGP (16). It has been suggested that improving the activation pattern of the local stabilizing muscles results in functional improvement in lumbopelvic pain patients (17, 18). Treatment that includes specific stabilizing exercises for the local muscles is effective for women with PGP during pregnancy using a home training approach (19). After pregnancy, Stuge et al. (20) successfully used a treatment concept including training of the global and local muscles, ergonomic advices, body awareness, and when indicated massage, mobilization, and stretching. Home training, following introduction of the exercises by a physiotherapist, is a common approach in the clinic settings for specific stabilizing exercises. The aim of the present study was to investigate if home-based specific stabilizing exercises focusing on the local stabilizing muscles are sufficient as treatment for women with persistent postpartum PGP or combined pain. Methods Study Design This was a prospective, randomized, clinically controlled study. The randomization procedure took place after a baseline examination was completed and eligibility was determined. The participants draw sealed envelopes (from the research physiotherapist) to assign to the treatment group or the reference group. The research physiotherapists who conducted the follow-ups were blinded to group assignments. Study participants Women with lumbopelvic pain were recruited from two geographical areas in Sweden during May 2002 to December 2004 (area 1) and during April 2007 to August 2008 (area 2), respectively. In area 1, women with persistent lumbopelvic pain 3 months postpartum belonging to an ongoing cohort study were identified (8). In area 2, midwifes identified women with persistent lumbopelvic pain at the follow-up visit 8-12 weeks after delivery. In both areas, the women were examined by one of two research physiotherapists. Classification of the pain problem was based on an examination starting with a standardized history. It was followed by mechanical assessment of the lumbar spine according to the Mechanical Diagnosis and Therapy protocol (MDT) (21) and pelvic pain provocation tests performed in the mentioned order; distraction test, posterior pelvic pain provocation test, Gaenslen s test, compression test, sacral thrust (22). To consider a pelvic pain provocation test positive it had to reproduce the women s familiar pain regarding localisation and quality. The active straight leg raising (ASLR) test (4-point scale, sum: 0-6) (23), hip rotation range-of-motion test, and a neurological examination were performed. The clinical examination is reliable and has been described in detail (22). Inclusion criteria for PGP were 2 positive pelvic pain provocation tests, pain onset during a pregnancy or within 3 weeks from delivery and pain located distal and/or lateral to the L5-S1 area in the buttocks. In addition to the criteria for PGP, some women also had pain localised in the lumbar region, centralization or peripheralization phenomenon and/or pain/symptoms during repeated movements/positions of the lumbar spine according to the classification of MDT. These women were considered to have PGP in combination with lumbar pain (combined pain) and were also included. Exclusion criteria were: systemic locomotor disease, a verified diagnosis of spinal problems in the previous two months, a history of fracture, neoplasm, or previous surgery of the spine, pelvis, or femur, insufficient Swedish language skills, treatment with specific stabilizing exercises during the previous 3 months, and ongoing pregnancy. All participants received oral and written information about the study before oral consent. Intervention The women assigned to the treatment group were instructed to exercise 2 times per day and to perform each exercise with 10 repetitions. The training consisted of specific stabilizing exercises and focused on the transversely oriented abdominal, the lumbar multifidus, and the pelvic floor muscles (24). Specific stabilizing training model includes principles of motor learning theory and consists of three stages: (1) local segmental control, (2) closed chain segmental control, and (3) open chain segmental control; in the present study with emphasize on daily activities. An individual program was made for each woman and exercises were chosen among 15 standardized and predesigned exercises. The level of the exercises was progressively increased during the treatment period with the goal to reach stage 3. In addition to the home training, individual guidance and adjustment of the exercise program were performed every second week by one of two treating physiotherapists. To measure compliance with the training program, a daily training diary was kept during the training period. The women in the reference group had one telephone contact with a physiotherapist. They received information about PGP and combined pain, including the fact that it is a common problem during pregnancy and that it disappears within a couple of months postpartum in the majority of the cases. They were instructed to resume their normal activities. Assessment In addition to the clinical examination, all participants completed questionnaires and underwent muscle function tests at inclusion approximately 3 months postpartum and again 3, 6, 12, and 24 months later. In this paper, the 3- and 6-month follow-ups are reported. Questionnaires Demographic data was collected at baseline, consisting of age, body mass index, physical activity level (1-6; 6 = most active; 1-3 = manage all household duties, including gardening and light physical activity; or 4-6: the aforementioned activities + exercises at increasing intensity) (25), current physical exercise frequency (never/sometime per month, 1-2 times/week, or 2 times/week) urinary leakage (yes/no), number of pregnancies, and number of children. Additionally, questions regarding delivery and pregnancy, i.e. weight of the newborn, breast feeding (yes/no), delivery mode (vaginal/caesarean), injuries during delivery (yes/no), lumbopelvic pain during pregnancy (yes/no), treatment of the lumbopelvic pain during pregnancy (yes/no), and postpartum depressive symptoms measured with the Edinburgh Postnatal Depression Scale (26) were evaluated at baseline. Questions regarding symptom satisfaction (delighted to mostly satisfied or mixed to terrible feelings) (27) and expectations of treatment (completely restored, quite improved, not improved but to get some relief of the symptoms, or no expectations of being restored) were collected. The primary outcome measure was disability, based on the Oswestry Disability Index (ODI) version 2.0 (28). Pain intensity was measured with a visual analogue scale (VAS) (0-100 mm) for current pain and average pain during the previous week. Pain frequency was also measured (always, day and night to several times per week, or occasionally to never). The EuroQol instrument (EQ-5D and EQ-VAS) was used to capture the women s perceived health-related quality of life (HRQL) (29). Wellbeing was measured with VAS (0-100 mm) having defined end-points (low value indicating high wellbeing). Muscle function Muscle function tests were performed to evaluate whether the treatment had targeted the muscle function or not. No encouragement was given during the tests. The tests were conducted as described below. Pelvic floor muscles The activity of the pelvic floor muscles was evaluated with surface electromyography (EMG). The EMG activity was recorded with Periform TM vaginal probe (Neen HealthCare, Dereham, UK). EMG signals were collected with NeuroTrac TM ETS (Verity Medical LDT, Surrey, UK). A ground electrode and an amplifier were placed on the right hip at the iliac crest in order to reduce noise from the recordings of the pelvic floor muscles. The between-trial reliability has been found to be good to high for the probe (ICC (3,1) = , CV = %) (30). The woman was supine on an examination bench with the legs extended. She was asked to contract her pelvic floor muscles as much as possible for 5 seconds and then to relax for 5 seconds. This sequence was repeated 5 times. Gait The women were timed walking barefoot for a distance of 20 meters at a comfortable speed on a horizontal floor (modified from Ljungqvist et al.) (31). Hip extensors Maximal voluntary isometric hip extension was measured by a dynamometer (Chatillon CSD 500 strength dynamometer, Ametek, Largo FL, US) with a fixed sensor. A sling was placed on the women s thigh at the distal end of the femur and pulled in extension. They were instructed to pull as hard as they could. Two training repetitions were performed. The mean of the next 3 repetitions were used for analyses. Each repetition consisted of 5 seconds work and 5-10 seconds rest. The procedure was performed on both legs; all women started with the right leg. Back flexors Isometric endurance of the back flexors was tested with women in the supine position with arms crossed over their chest, hips bent, and knees and feet apart. They were asked to nod and to continue to lift their head and shoulders until the inferior angle of the scapula was lifted from the examination bench, and to hold the position for as long as possible (modified from McQuade et al.) (32). The time that the position was maintained was recorded in seconds and the test was interrupted after a maximum of 120 seconds. Back extensors Isometric endurance of the back extensors was tested with women in the prone position with arms crossed over the chest and the trunk horizontal and transversely outside the examination bench. The pelvis and the lower legs were fixated to the examination bench by straps and by the tester, respectively (modified from Biering-Sörensen) (33). The time that the position was maintained was recorded in seconds and the test was interrupted after a maximum of 120 seconds. Statistical analysis Power analysis was based on a cohort of postpartum women (8). With a beta level of 80% and a difference between the groups in ODI of 10%, 21 participants per group were required. Two-group comparisons were made with Student s t-test for continuous data. The Mann-Whitney U test was used for ordinal data and the χ 2 test or, when appropriate, the Fisher exact test was performed on nominal data. Within-group comparisons were made with paired t-test for continuous data, the Wilcoxon signed rank for data on ordinal level, and the McNemar test was used for dichotomous variables. Statistical significance was set at an alpha level of The statistical software package SPSS was used (version 17.0; SPSS, Inc., Chicago, IL). The Regional Research Ethics Committee approved the study (Ö414-00, T018-07). Results Study sample A total of 88 women were included in the study. Sixty-five (74 %) and 60 (68 %) women completed the 3-month and 6-month follow-up, respectively (Fig.1). There were no significant differences between groups from the two geographical areas at the baseline. The age of the participants and weight of the newborn babies differed significantly between the treatment group and the reference group (Table I). No differences could be detected between the groups at the baseline regarding disability, pain intensity, pain frequency, HRQL, or muscle parameters (Tables II and III). The severity of the PGP measured with the ASLR test did not differ between the treatment group (median score 0; range 0-2) and the references group (median 0; range 0-4)(P = 0.150). The only woman who scored 4/6 (none scored 3) did not participate in any follow-up. Of the 21 participants who were not included in the three months follow-up, a lower proportion reported urinary leakage (2/21 (10 %) vs. 21/65 (32%) P=0.040), had less number of children living at home (P=0.046), and had a lower proportion of cesarean delivery (0/21 vs. 12/65 (18.5%) P=0.034) than the 65 included. The 26 participants who were not included in the six months follow-up, were older than the 60 included (32 years vs. 30; P=0.040). There was no difference in primary outcome (ODI) between women included and women not included in the two follow-ups. Intervention outcome On average 5 (SD 3) physiotherapy sessions were performed and on average 7 (SD 3) exercises were prescribed to the women by the treating physiotherapist. No woman trained 2 times/day in average during their training period, 10 woman trained 1.5 times/day in average and 15 woman trained 1.5 times/day. Seven diaries were not handed in. Seventy-eight percent of the women in the treatment group reached stage 3 in the treatment program. Eight women in the treatment group received additional treatment (acupuncture, transcutaneous electrostimulation, ultrasound treatment, massage, pelvic belt) along with specific local stabilizing exercises. Disability For the primary outcome, ODI, no difference could be demonstrated between the two groups at 3- or 6-month follow-up (P = 0.205; P = 0.358) (Table II). Within-group difference for the ODI was shown for the treatment group at 3-month follow-up. Both groups showed within group differences at 6-month follow-up compared with baseline (Table II). Pain, HRQL, and wellbeing A significant difference in pain frequency was demonstrated between the two groups at the 3-month follow-up (P = 0.011) in favor of the treatment group. Pain was experienced always, day and night to several times per week in 87% of women in the reference group and in 58% of women in the treatment group. No differences could be detected between the groups regarding pain intensity, HRQL or wellbeing (Table II). Within-group comparisons showed that the pain intensity had decreased in the two groups both at 3- and 6-month follow-up compared with baseline (Table II). The pain frequency decreased in the reference group at the 6-month follow-up compared with baseline (P = 0.022). Fifty-nine percent in the reference group experienced pain always, day and night to several times per week at the 6-month follow-up compared with 87% at the baseline (in the treatment group 54% vs 79% at baseline (P = 0.180)). Symptom satisfaction No differences were found between the two groups regarding symptom satisfaction at 3- or 6-month follow-up (Table II). The treatment group had improved symptom satisfaction (P = 0.039) at 3-month follow-up. Fifty-four percents were delighted to mostly satisfied compared with 27% at the baseline. At 6-month follow-up, both groups had improved symptom satisfaction. Sixty-three percent of the women in the treatment group were delighted to mostly satisfied compared with 27% at the baseline (P = 0.001); in the reference group 77% vs 33% at the baseline (P = 0.022). Muscle function A significant difference was demonstrated between the two groups for the mean hip extension left at 3-month follow-up (P=0.047)(Table III). Within-group comparisons showed an improvement in several of the global muscles measured but not the pelvic floor muscles in both groups at the 3- and 6-month follow-up compared with baseline (Table III). Discussion The main finding of this study was that the concept of home-based specific stabilizing exercises focusing on the transversely oriented abdominal muscles, the lumbar multifidus, and the pelvic floor muscles were no more effective in improving back-related disability, HRQL, or reducing pain than the clinically natural course in women with persistent postpartum PGP or combined pain. A difference in pain frequency was demonstrated between the two groups at the 3-month follow-up in favor of the treatment group. Based on within group comparisons, there were tendencies in the same direction with the women in the treatment group rating the disability and the con
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