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Effects of acupuncture and stabilising exercises as adjunct to standar
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     1 Perinatal Center, Department of Obstetrics and Gynecology, Institute for the Health of Women and Children, Sahlgrenska Academy, East Hospital, 41685 Gothenburg, Sweden, 2 Department of Occupational Therapy and Physical Therapy, Sahlgrenska Academy, Sahlgrenska Hospital, Gothenburg, 3 Department of Orthopedics, Sahlgrenska Academy, Molndal Hospital, Molndal, Sweden

    Correspondence to: H Elden helen.elden@vgregion.se

    Objectives To compare the efficacy of standard treatment, standard treatment plus acupuncture, and standard treatment plus stabilising exercises for pelvic girdle pain during pregnancy.

    Design Randomised single blind controlled trial.

    Settings East Hospital, Gothenburg, and 27 maternity care centres in Sweden.

    Participants 386 pregnant women with pelvic girdle pain.

    Interventions Treatment for six weeks with standard treatment (n = 130), standard treatment plus acupuncture (n = 125), or standard treatment plus stabilising exercises (n = 131).

    Main outcome measures Primary outcome measure was pain (visual analogue scale); secondary outcome measure was assessment of severity of pelvic girdle pain by an independent examiner before and after treatment.

    Results After treatment the stabilising exercise group had less pain than the standard group in the morning (median difference = 9, 95% confidence interval 1.7 to 12.8; P = 0.0312) and in the evening (13, 2.7 to 17.5; P = 0.0245). The acupuncture group, in turn, had less pain in the evening than the stabilising exercise group (-14, -18.1 to -3.3; P = 0.0130). Furthermore, the acupuncture group had less pain than the standard treatment group in the morning (12, 5.9 to 17.3; P < 0.001) and in the evening (27, 13.3 to 29.5; P < 0.001). Attenuation of pelvic girdle pain as assessed by the independent examiner was greatest in the acupuncture group.

    Conclusion Acupuncture and stabilising exercises constitute efficient complements to standard treatment for the management of pelvic girdle pain during pregnancy. Acupuncture was superior to stabilising exercises in this study.

    Pelvic girdle pain is a common complaint among pregnant women worldwide,1 and it causes severe pain in one third of affected women.2 3 Strenuous work, previous low back pain, and previous pelvic girdle pain are known risk factors.3 4

    Pelvic girdle pain generally arises in relation to pregnancy, trauma, or reactive arthritis. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints. The pain may radiate in the posterior thigh and can occur in conjunction or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished.5 After pregnancy problems remain serious in about 7% of women with pelvic girdle pain, causing severe discomfort and reducing ability to work.3 6

    Most studies do not distinguish between lumbar back pain and pelvic girdle pain.6 Unspecified diagnosis is a problem, as the two conditions differ with respect to prognosis and treatment.2 5 If a patient with pelvic girdle pain is treated for low back pain, the symptoms may be aggravated.2 Pelvic girdle pain must be reproducible by specific pain provocation tests.3 5 7 8 The posterior pelvic pain provocation test and Patrick's fabere test have the best sensitivity if pain is evident in the sacroiliac joints.5 8 Modified Trendelenburg's test and palpation of the symphysis have better sensitivity if pain is evident in the symphysis pubis.8 These tests have high intertester reliability.5 8

    Standard treatment may consist of a pelvic belt, a home exercise programme, and patient education. A systematic review has shown that the efficacy of these interventions remains questionable.9 Current treatment increasingly includes stabilising exercises and acupuncture.10-12 However, insufficient evidence is available to give strong recommendations for or against any particular treatment modality for pelvic girdle pain.13 We compared the efficacy of acupuncture or stabilising exercises as an adjunct to standard treatment with standard treatment alone for the treatment of pelvic girdle pain in pregnant women.

    Methods

    The study was a randomised single blind trial done at East Hospital, Sahlgrenska Academy, and at 27 maternity care centres in the hospital's reference area in Gothenburg, Sweden, from 2000 to 2002.

    Participants

    Doctors and midwifes at the 27 maternity care centres preselected consecutive patients. Participants filled in a previously validated questionnaire2 and a diary for baseline information for one week before the inclusion visit. An independent specially trained physiotherapist then assessed patients who were eligible and willing to participate in the study. This assessment included a detailed standardised physical examination and collection of baseline data. The tests used were the posterior pelvic pain provocation test, Patrick's fabere test, a modified Trendelenburg's test, Lasegue test, and palpation of the symphysis pubis.5 8 The main inclusion criteria were healthy women at 12-31 completed gestational weeks, well integrated in the Swedish language, with singleton fetuses and defined pregnancy related pelvic girdle pain. We excluded patients with other pain conditions, systemic disorders, or contraindications to treatment. The participants gave informed consent.

    Randomisation

    A research assistant used a computer generated random table to determine the allocation sequence before the study. Groups were coded, and the allocation was transferred to a series of presealed opaque envelopes. The independent examiner randomised the patients individually after doing the baseline assessment.

    Treatment protocols

    The study comprised a one week baseline period, six weeks of treatment, and follow up one week after the last treatment. Patients were asked to avoid other treatments during the intervention period. Three experienced physiotherapists gave standard treatment, two experienced medical acupuncturists did acupuncture, and two experienced physiotherapists gave the stabilising exercises. All possible adverse events were recorded.

    Standard treatment group—Standard treatment consisted of general information about the condition and anatomy of the back and pelvis. Adequate advice was given about activities of daily living. The physiotherapist made sure that the patient understood and respected the relation between impairment, load demand, and actual loading capacity as well as the importance of necessary rest. The purpose of this information was to reduce fear and to enable patients to become active in their own treatment. The patients were given a pelvic belt (Puff Ig?ng AB, Sweden) and a home exercise programme designed to increase strength in the abdominal and gluteal muscles.

    Acupuncture—Patients received the same treatment as in the standard group but in addition had acupuncture. Local acupuncture points were selected individually after diagnostic palpation to identify sensitive spots.14 A total of 10 segmental points and seven extrasegmental points were used (table 1). The needles (Hegu AB, Landsbro, Sweden) were made of stainless steel (? 0.30) and inserted intramuscularly to a depth of 15-70 mm to evoke needle sensation (De Qi), described as tension, numbness, and often a radiating sensation from the point of insertion, reflecting activation of muscle-nerve afferents. The needles were left in situ for 30 minutes and manually stimulated every 10 minutes. Treatment was given twice a week over six weeks. Fetal heart rate and maternal heart rate and blood pressure were monitored before and after all treatments.

    Table 1 Acupuncture points, their anatomical position, and their innervation

    Stabilising exercises—Patients received the same treatment as in the standard group but in addition did stabilising exercises modified because of the pregnancy (box).15 16 The training programme started by emphasising activation and control of local deep lumbopelvic muscles. Training of more superficial muscles in dynamic exercises to improve mobility, strength, and endurance capacity was gradually included. Patients received treatments individually for a total of six hours during six weeks. They were told to integrate the exercises in daily activities and to exercise in short sessions on several occasions during the day.

    Outcome measures

    Primary outcome measure—Patients scored their current intensity of pelvic pain related to motion on a 100 point visual analogue scale every morning and every evening in the diaries.

    Secondary outcome measures—The independent examiner assessed recovery from symptoms. Patients were asked not to reveal any information about their treatment during assessment.

    Statistical analysis

    When planning the study we assumed that the mean pain score related to motion at baseline would be 60 mm (visual analogue scale) in all three groups. We did not expect any treatment effect in the standard group. We assumed that the mean pain score after treatment would be 60 mm in the standard group, 50 mm in one treatment group, and 40 mm in the other. To achieve a 90% power of detecting a significance (at the two sided 5% level), with an assumed standard deviation of 40, we needed 103 patients for each study group. To compensate for an anticipated loss to follow up of 20%, we needed 386 patients. When analysing the study we decided to apply the Mann-Whitney U test for comparing changes in pain scores, with Bonferroni's correction (P values multiplied by three). The power achieved with that method was 86% for comparison of the two most extreme groups, provided that μ/ = 0.5.

    Personnel from an independent institution coded all results from the study and entered them into a database. Analyses were done by intention to treat. The statistician who did the analysis was blinded to group and treatment. In the analysis of the pain diaries we defined the median visual analogue scale baseline levels in the mornings and in the evenings for each patient by calculating the median for the days before treatment (five to seven days). The same calculations of median pain were done for the first week after the end of treatment.

    Treatment protocol for the stabilising exercise group

    Additional information about anatomy and the genesis of pelvic pain and discussion about how the basic written regimen could be integrated at home and at work

    Exercises for stabilising the pelvis and back—that is, training of the transversus abdominis and the multifides facilitated by contractions of the pelvic floor muscles, according to Richardson and Jull but modified because of the pregnancy.16 While the standard positions (prone and supine) were not suitable the pressure biofeedback unit was not used. The exercises were done with the patient lying on her side, four point kneeling, sitting, and standing. Arm and leg movements were added when the basic movement was correct

    Exercises for increasing circulation in hip rotator muscles. The exercises were done with many repetitions during low force and in a limited range of motion in a side lying position with a pillow between the legs or sitting without foot support

    Massage, effleurage, and petrissage of hip extensors and rotators

    Stretching of hip external rotators and extensors in the sitting position: 20 sec/stretch

    We calculated the medians, quartiles, means, and standard deviations when possible. We used the Mann-Whitney U test to compare differences between the groups for continuous variables and 2 for categorical variables. Adjustments (multiplication by three) of the P values due to multiple comparisons were done by Bonferroni's method. We considered an adjusted P value < 0.05 to be statistically significant. We calculated median differences and confidence intervals for the differences between medians on the basis of the Mann-Whitney U test. We also did an analysis of treatment effects in patients divided into four subgroups17: one sided sacroiliac pain, double sided sacroiliac pain, one sided sacroiliac pain plus symphysis pubis pain, and pelvic girdle syndrome (double sided sacroiliac pain plus symphysis pubis pain). The results were analysed with the SAS software package, version V8.

    Results

    Randomisation and progress through the trial

    Of 558 women referred for the first assessment, 172 did not meet the inclusion criteria; 386 women were included in the trial. Baseline characteristics were similar in the three treatment groups (table 2). The figure show the progress of patients through the trial and withdrawals from the study.

    Table 2 Characteristics of 386 pregnant women with pelvic girdle pain included in trial. Values are numbers (percentages) unless stated otherwise

    Participants' progress through trial and withdrawals

    Primary outcome measure

    Table 3 shows improvements in pain scores. The reduction in pain was most pronounced in the evening in the acupuncture group one week after the end of treatment, compared with the other treatment groups.

    Table 3 Primary outcome measure: pain on visual analogue scale related to motion one week after treatment compared with baseline measurements

    Secondary outcome measures

    Table 4 shows that attenuation of pelvic girdle pain assessed by the independent examiner was greatest in the acupuncture group. Three of four subgroups of pelvic girdle pain improved after acupuncture compared with standard treatment and one of four subgroups improved compared with the stabilising exercise group.

    Table 4 Secondary outcome measure: assessment of severity of pelvic girdle pain by an independent examiner before intervention and at follow up after last treatment. Values are numbers (percentages) unless stated otherwise

    Side effects

    No serious complication occurred during treatments or during the follow up period after any of the treatments.

    Discussion

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    ((Helen Elden, midwife1, Lars Ladfors, hea)