Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial

Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness...

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Published inBMC pregnancy and childbirth Vol. 15; no. 1; p. 36
Main Authors Flack, Natasha A M S, Hay-Smith, E Jean C, Stringer, Mark D, Gray, Andrew R, Woodley, Stephanie J
Format Journal Article
LanguageEnglish
Published England BioMed Central 15.02.2015
BioMed Central Ltd
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Abstract Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651 , 25th August, 2014.
AbstractList BACKGROUNDPregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use).METHODSUnblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week.RESULTSTwenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported.CONCLUSIONThese preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful.TRIAL REGISTRATIONAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651 , 25th August, 2014.
BACKGROUND: Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). METHODS: Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. RESULTS: Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference −0.1; 95% CI: −2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference −2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. CONCLUSION: These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651, 25th August, 2014.
Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651 , 25th August, 2014.
Background: Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Methods: Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Results: Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. Conclusion: These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. 38 references
Background Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Methods Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Results Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference −0.1; 95% CI: −2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups’ data, function and pain were significantly improved at three weeks (mean difference −2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. Conclusion These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651, 25th August, 2014.
ArticleNumber 36
Author Hay-Smith, E Jean C
Flack, Natasha A M S
Stringer, Mark D
Woodley, Stephanie J
Gray, Andrew R
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SSID ssj0017850
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Snippet Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support...
Background Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic...
BACKGROUNDPregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic...
Background: Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed...
BACKGROUND: Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed...
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Index Database
StartPage 36
SubjectTerms Activities of Daily Living
Adult
Back pain
Biomechanics
Braces
Clinical trials
Evidence-based medicine
Female
Humans
Pain Management - instrumentation
Pain Management - methods
Pain Measurement
Patient Compliance
Patient Preference
Pelvic Girdle Pain - diagnosis
Pelvic Girdle Pain - etiology
Pelvic Girdle Pain - physiopathology
Pelvic Girdle Pain - therapy
Pregnancy
Pregnancy complications
Pregnancy Complications - diagnosis
Pregnancy Complications - etiology
Pregnancy Complications - physiopathology
Pregnancy Complications - therapy
Questionnaires
Text messaging
Treatment Outcome
Womens health
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Title Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial
URI https://www.ncbi.nlm.nih.gov/pubmed/25885585
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https://pubmed.ncbi.nlm.nih.gov/PMC4339641
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