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Effects Of Multimodal Physical Therapy Intervention On Musculoskeletal Function And Low Back Pain In Postpartum Women

25. srpna 2026 aktualizováno: Riphah International University

Postpartum low back pain is a common musculoskeletal problem that affects women's functional ability, childcare activities, and quality of life after childbirth. Hormonal, biomechanical, and muscular changes during pregnancy and the postpartum period, including reduced core stability and pelvic floor weakness, contribute to persistent lumbopelvic pain and disability. In Pakistan, awareness and access to postpartum physiotherapy rehabilitation remain limited despite the high prevalence of postpartum low back pain.

Evidence suggests that multimodal physiotherapy interventions, including core stabilization exercises, pelvic floor training, manual therapy, ergonomic advice, and patient education, can effectively reduce pain and improve functional outcomes in postpartum women. However, limited randomized controlled trials have been conducted in Pakistan to evaluate these interventions.

The aim of this study is to determine the effects of a multimodal physical therapy intervention on low back pain, musculoskeletal function, core endurance, fatigue, and quality of life in postpartum women.

This study will be conducted as a single-blinded, two-arm parallel randomized controlled trial at Ayub Medical Complex Abbottabad and CMH Abbottabad. A total of 40 postpartum women aged 20-40 years with low back pain within six months after delivery will be recruited and randomly allocated into experimental and control groups.

The experimental group will receive a six-week multimodal physiotherapy program consisting of core stabilization exercises, pelvic floor muscle training, manual therapy, posture correction, ergonomic education, and home exercise guidance. The control group will receive routine postpartum care only.

Outcome measures will include the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), core endurance tests, SF-36 Quality of Life Questionnaire, and PROMIS® Fatigue Short Form. Assessments will be conducted at baseline, post-intervention, and follow-up.

Data will be analyzed using SPSS version 29 with appropriate statistical tests for within-group and between-group comparisons. Ethical approval and informed consent procedures will be ensured before data collection.

This study is expected to provide evidence regarding the effectiveness of multimodal physiotherapy in improving pain, function, and quality of life among postpartum women and may support the integration of physiotherapy into routine maternal healthcare services in Pakistan.

Přehled studie

Detailní popis

Postpartum low back pain is a common musculoskeletal condition that significantly affects women's physical function, mobility, childcare activities, emotional well-being, and quality of life after childbirth. During pregnancy and the postpartum period, women experience several hormonal, biomechanical, and musculoskeletal changes, including ligamentous laxity, altered posture, weakened abdominal and pelvic floor muscles, reduced core stability, and changes in spinal alignment, all of which may contribute to persistent lumbopelvic pain and functional limitations. Repetitive infant care activities such as lifting, carrying, breastfeeding, bending, prolonged sitting, and sleep-related postural stress may further aggravate symptoms and delay recovery. Despite the high prevalence of postpartum low back pain, rehabilitation services for postpartum women remain limited in Pakistan due to inadequate awareness, sociocultural barriers, lack of structured physiotherapy programs, and limited integration of rehabilitation within maternal healthcare systems. Consequently, many women continue to experience untreated pain, fatigue, disability, reduced physical performance, and impaired quality of life during the postpartum period. Current evidence supports the effectiveness of multimodal physiotherapy interventions for postpartum musculoskeletal dysfunction, particularly approaches combining core stabilization exercises, pelvic floor muscle training, manual therapy, ergonomic education, posture correction, activity modification, and patient counseling. However, most available evidence originates from high-income countries, and there is limited research evaluating the effectiveness of structured multimodal rehabilitation programs in Pakistani postpartum women. Therefore, this study aims to evaluate the effects of a multimodal physical therapy intervention on low back pain and musculoskeletal function in postpartum women. Secondary outcomes include assessment of core muscle endurance, functional disability, fatigue, and health-related quality of life. The study will be conducted using a single-blinded, two-arm parallel randomized controlled trial design in tertiary healthcare settings. Eligible postpartum women experiencing low back pain within six months after delivery will be recruited and randomly allocated into either an intervention group or a control group. The intervention group will receive a structured six-week multimodal physiotherapy program consisting of supervised core stabilization exercises, pelvic floor muscle activation and strengthening, manual therapy techniques, ergonomic training, posture correction, pain management education, safe lifting techniques, breastfeeding posture guidance, sleep positioning advice, and home exercise instruction. The control group will receive routine postpartum care without supervised physiotherapy intervention. Outcome measures will include pain intensity, functional disability, core muscle endurance, fatigue, and quality of life assessed using standardized clinical tools at baseline, post-intervention, and follow-up. Ethical approval and informed consent procedures will be ensured prior to commencement of the study, and participant confidentiality will be maintained throughout the research process. The findings of this study may contribute to the development of evidence-based postpartum rehabilitation protocols, improve awareness regarding women's health physiotherapy, support integration of physiotherapy services into routine maternal healthcare practices, and enhance postpartum recovery, functional independence, and quality of life among women in Pakistan.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Within six months postpartum following vaginal or caesarean delivery.
  • Experiencing low back pain or lumbopelvic pain after childbirth.
  • Pain intensity ≥3 on the Numeric Pain Rating Scale during activity or rest.
  • Able to attend supervised physiotherapy sessions for six consecutive weeks.
  • Willing to provide informed consent and participate in follow-up assessments.

Exclusion Criteria:

  • History of spinal surgery or diagnosed structural spinal deformities such as scoliosis, spondylolisthesis, or disc herniation.
  • Severe postpartum complications including postpartum haemorrhage, infection, or wound dehiscence limiting physical activity.
  • Pelvic organ prolapse grade II or above or severe pelvic floor dysfunction requiring specialized care.
  • Uncontrolled systemic illness such as diabetes mellitus, hypertension, or thyroid dysfunction affecting exercise tolerance.
  • Current participation in another structured physiotherapy or rehabilitation program for low back pain.
  • Neurological disorders or musculoskeletal conditions unrelated to postpartum low back pain that may affect outcomes.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Multimodal Physiotherapy
Participants will complete baseline assessment of pain (NPRS), disability (ODI), core endurance, quality of life (SF-36), and fatigue (PROMIS® Fatigue Short Form). They will receive a multimodal physiotherapy program, 3 sessions/week for 45 minutes, comprising: (1) core stabilization exercises (abdominal bracing, pelvic tilts, partial curl-ups, bridging, modified side bridge, bent-knee lowering) with progressive supervised loading; (2) manual therapy (soft tissue mobilization and Maitland mobilization, Grades I-III) to lumbopelvic and paraspinal structures; and (3) patient education on posture, lifting ergonomics, sleep positioning, pain management, home exercise adherence, and graded activity return. Post-intervention reassessment will use the same outcome measures, with monitoring of adherence, adverse effects, and satisfaction. A follow-up at two weeks post-program will assess maintenance of outcomes and long-term adherence to exercise and lifestyle changes.

Here's the Detailed Description of Intervention field for the experimental group, at ~1000 characters:

Multimodal Physiotherapy: Participants will receive a structured physiotherapy program delivered 3 sessions/week, 45 minutes/session, comprising three components. (1) Core stabilization exercises: abdominal bracing, pelvic tilts, partial curl-ups, bridging, modified side bridge, and bent-knee lowering, with progressive supervised loading. (2) Manual therapy: soft tissue mobilization and Maitland joint mobilization (Grades I-III) applied to lumbopelvic and paraspinal structures. (3) Patient education: guidance on posture correction, lifting ergonomics, sleep positioning, pain self-management, home exercise adherence, and graded return to activity. Baseline and post-intervention outcomes (pain via NPRS, disability via ODI, core endurance, SF-36 quality of life, and PROMIS® Fatigue Short Form) will be recorded, alongside monitoring of adherence, adverse effects, and satisfaction.

Aktivní komparátor: Conventional Postpartum Care
Participants will undergo baseline assessment of pain (Numeric Pain Rating Scale), functional disability (Oswestry Disability Index), core muscle endurance, health-related quality of life (SF-36), and fatigue (PROMIS® Fatigue Short Form), followed by education on study procedures and collection of informed consent. Participants will receive usual postpartum care only, consisting of standard hospital discharge instructions on rest, basic posture care, and general physical activity, with no supervised physiotherapy sessions or structured exercise plan provided. Following the intervention period, participants will be reassessed using the same battery of outcome measures (NPRS, ODI, SF-36, core endurance tests, and PROMIS® Fatigue Short Form). A follow-up assessment will be conducted two weeks after the sixth-week evaluation to allow comparative monitoring of pain and functional recovery relative to the experimental group.
Participants will receive standard postpartum care as routinely provided at hospital discharge, with no supervised physiotherapy sessions or structured exercise plan. This will include general instructions on rest, basic posture care during daily activities and infant care, and advice on gradual resumption of general physical activity, delivered as part of routine discharge counseling by hospital staff. No formal core stabilization exercises, manual therapy, or individualized graded exercise progression will be provided. Baseline and post-intervention outcomes (pain via NPRS, disability via ODI, core endurance, SF-36 quality of life, and PROMIS® Fatigue Short Form) will be recorded at the same time points as the experimental group, allowing direct comparison. A follow-up assessment will be conducted two weeks after the sixth-week evaluation to monitor pain and functional recovery over time, without any additional structured intervention provided during the follow-up period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Low Back Pain Intensity
Časové okno: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 8)
Low back pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 ("no pain") to 10 ("worst imaginable pain"). The scale will be used to evaluate changes in pain severity in postpartum women receiving multimodal physical therapy intervention compared with routine postpartum care.
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 8)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Disability due to Low Back Pain
Časové okno: Baseline (Week 0), Week 6, and Week 8
Functional disability will be assessed using the Oswestry Disability Index (ODI), a validated 10-item questionnaire evaluating limitations in activities of daily living caused by low back pain. Higher scores indicate greater disability.
Baseline (Week 0), Week 6, and Week 8
Core Endurance Tests
Časové okno: 4 months
Partial Curl-Up Test assesses abdominal muscle endurance by recording the maximum number of controlled trunk flexions performed at a fixed pace while maintaining correct form. Bent Knee Lowering Test evaluates lower abdominal control and core stability by assessing pelvic control while the knees are lowered from a flexed position. Modified Bridge Endurance Test measures trunk and hip extensor endurance by recording the duration a bridge position is maintained with correct alignment. Seated Trunk Flexor Endurance Test assesses anterior trunk endurance by timing maintenance of a 60° seated flexed position without support. Modified Side Bridge Test evaluates lateral trunk endurance by recording the duration a side bridge position is maintained on the forearm and knees.
4 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Exercise and Treatment Adherence
Časové okno: During Weeks 1-6
Participant adherence to supervised physiotherapy sessions and prescribed home exercise programs will be monitored throughout the 6-week intervention period using attendance and compliance records.
During Weeks 1-6

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Taqdees Sohail, Riphah International University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

5. října 2026

Dokončení studie (Odhadovaný)

30. prosince 2026

Termíny zápisu do studia

První předloženo

25. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. srpna 2026

První zveřejněno (Aktuální)

27. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • RIU/RCRAH-ISB/REC/MSPT/02463

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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