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NCT Number: NCT07790848

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal physiotherapy

Other

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.

Standard Postpartum Care

Other

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.

Primary outcomes

  1. Low Back Pain Intensity

    Time frame: 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.

Secondary outcomes

  1. Functional Disability due to Low Back Pain

    Time frame: 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.

  2. Core Endurance Tests

    Time frame: 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.

Other outcomes

  1. Exercise and Treatment Adherence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maryam Kundi

CONTACT

[email protected]

+923405754453

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Collaborators

  • Combined Military Hospital Abbottabad

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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