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.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Maryam Kundi
- 电话号码:+923405754453
- 邮箱:maryam.kundi@riphah.edu.pk
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Low Back Pain Intensity
大体时间: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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional Disability due to Low Back Pain
大体时间: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
大体时间: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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise and Treatment Adherence
大体时间: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
|
合作者和调查者
调查人员
- 首席研究员:Taqdees Sohail、Riphah International University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RIU/RCRAH-ISB/REC/MSPT/02463
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.