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

NCT07790848 | Not Yet Recruiting DMC

• 1 other identifier: RIU/RCRAH-ISB/REC/MSPT/02463
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Back Biomechanical Dysfunctions; Post Partum

Keywords

Postpartum Women Low Back Pain Multimodal Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Low Back Pain Intensity

  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)

Secondary Outcomes (2)

• Functional Disability due to Low Back Pain

  Baseline (Week 0), Week 6, and Week 8

• Core Endurance Tests

  4 months

Other Outcomes (1)

• Exercise and Treatment Adherence

  During Weeks 1-6

Study Arms (2)

Multimodal Physiotherapy

EXPERIMENTAL

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.

Other: Multimodal Physiotherapy

Conventional Postpartum Care

ACTIVE COMPARATOR

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.

Other: Standard Postpartum Care

Interventions

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.

Multimodal Physiotherapy

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.

Conventional Postpartum Care

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Eligible participants may self-identify as women, who are biologically female and have experienced pregnancy and childbirth within the specified postpartum period.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead
• Combined Military Hospital Abbottabad: collaborator

Study Officials

• Taqdees Sohail

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Kundi

CONTACT

+923405754453; maryam.kundi@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share