Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058622) titled 'The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Okayama City Hospital
Condition:
Condition - Pregnancy-related low back pain and pelvic girdle pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effectiveness of an exercise programme and pelvic belt use in women with pregnancy-related low back and pelvic girdle pain.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - An exercise programme delivered via instructional video
Interventions/Control_2 - An exercise programme delivered via instructional video plus pelvic belt use
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1. Within one week postpartum and experiencing pregnancy-related low back and pelvic girdle pain
2. Not wearing a pelvic belt at the time of study enrolment and not planning to wear one, or currently wearing a pelvic belt but willing to switch to the study-provided belt if allocated to the exercise programme plus pelvic belt group
Key exclusion criteria - 1. Individuals unable to participate in exercise therapy
2. Individuals with hypersensitivity to pelvic belts
3. Individuals with a history of lumbar or pelvic fracture or surgery
4. Individuals who underwent postpartum hysterectomy or uterine artery embolisation
5. Individuals with comorbid psychiatric disorders
Target Size - 160
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 03 Month 11 Day
Date of IRB - 2025 Year 03 Month 11 Day
Anticipated trial start date - 2025 Year 07 Month 28 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067007
Disclaimer: Curated by HT Syndication.
