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Active, not recruiting

NCT Number: NCT07777731

Effect of Tele-Rehabilitation on Low Back Pain, Fatigue, and Psychological Well-being in Postpartum Women Following C-Section

The goal of this study is to learn whether tele-rehabilitation helps postpartum women recover from low back pain after a cesarean section (C-section). The study will also look at whether tele-rehabilitation helps reduce fatigue, improve psychological well-being, and make daily activities easier.

The main questions it aims to answer are:

* Does tele-rehabilitation reduce low back pain in postpartum women after a C-section? * Does it reduce postpartum fatigue? * Does it improve psychological well-being? * Does it improve the ability to perform daily activities?

Participants will:

* Be selected using a computer-generated random sampling method from eligible postpartum women. * Complete assessments before and after the treatment program. * Receive therapeutic exercises and ergonomic education through tele-rehabilitation if assigned to the intervention group. * Receive ergonomic education about posture, breastfeeding, lifting, carrying, and back care if assigned to the control group. * Complete questionnaires about their pain, fatigue, psychological well-being, and ability to perform daily activities.

The study may help determine whether tele-rehabilitation is a practical way to provide physiotherapy support to women recovering at home after a C-section.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Institute of Medical Sciences (PIMS)

Islamabad, Punajb, 44000, Pakistan

About this study

Detailed Description

This study will evaluate the effect of a structured tele-rehabilitation program on low back pain, fatigue, and psychological well-being among postpartum women following cesarean section. The study will use a two-arm randomized controlled trial design. Participants will be recruited according to predefined eligibility criteria and will be randomly allocated to either an intervention group or an active comparator group.

The study will include postpartum women aged 20 to 40 years who have experienced low back pain following cesarean section and who are able to participate in tele-rehabilitation sessions. Participants with postpartum complications, neurological deficits, diagnosed spinal pathology, current physiotherapy treatment, or contraindications to exercise will be excluded. The study will be conducted over a 6-week intervention period, with assessments performed before and after the intervention. The synopsis specifies a postpartum recruitment period of approximately 2-6 weeks after delivery.

Participants will be randomly allocated using computer-generated randomization into two groups. The intervention group will receive tele-rehabilitation consisting of therapeutic exercises combined with ergonomic education and back-care advice. The active comparator group will receive ergonomic education and back-care advice without the therapeutic exercise component. Randomization will be performed independently of outcome assessment, and outcome assessors will be blinded to group allocation where feasible.

The therapeutic exercise program will be designed for postpartum women following cesarean section and will progress gradually according to participants' tolerance. The program will include gentle mobility exercises, pelvic and core muscle activation, pelvic floor exercises, strengthening exercises, and postural control activities. Exercises will include ankle pumps, heel slides, pelvic rocking, pelvic tilts, butterfly stretching, Kegel exercises, bridging, bow-and-arrow exercises, and shoulder rolls. Participants will also be encouraged to follow a gradually progressive walking program.

Ergonomic education will be provided to both groups. The education will focus on posture correction and safe performance of common postpartum activities. Participants will receive guidance regarding sitting and standing posture, breastfeeding and feeding positions, lifting and carrying the baby, bed mobility, bending and reaching, household activities, avoidance of prolonged flexed postures, back-care strategies, and activity pacing. Educational material will also be provided for home reference.

The tele-rehabilitation sessions will be delivered remotely through video-based communication platforms. Participants will receive guidance and supervision during the intervention and will be instructed to perform the prescribed exercises at home. Adherence will be monitored through follow-up communication, exercise records, or self-reported practice. Any pain or discomfort experienced during exercise will be monitored, and the exercise program will be modified when necessary.

The primary outcomes will include low back pain intensity, fatigue, and psychological well-being. Low back pain will be assessed using the Visual Analog Scale (VAS), fatigue will be assessed using the 9-item Fatigue Severity Scale (FSS), and psychological well-being will be assessed using the WHO-5 Well-Being Index. Functional disability related to low back pain will be assessed as a secondary outcome using the Oswestry Disability Index (ODI). The outcomes will be measured at baseline and immediately after completion of the 6-week intervention.

The study will determine whether adding therapeutic exercises through tele-rehabilitation to ergonomic education will provide greater improvements in low back pain, fatigue, and psychological well-being than ergonomic education alone. The findings will help assess whether remotely supervised rehabilitation can provide a practical and accessible physiotherapy approach for postpartum women who may experience difficulties accessing in-person rehabilitation after cesarean section.

The study will also provide information about the potential role of tele-rehabilitation in improving functional ability and reducing the impact of postpartum low back pain on daily activities. The results may support the development of accessible home-based physiotherapy programs for postpartum women, particularly in settings where regular face-to-face physiotherapy may be difficult to access.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Postpartum women between 2-6 weeks after delivery
  • Age 20-40 years
  • Primiparous or multiparous
  • Mild to moderate low back pain
  • Able to participate in tele-rehabilitation sessions
  • Post caesarian women

Exclusion criteria

  • • Postpartum complications (e.g., infection, delayed healing)
  • Neurological deficits
  • Diagnosed spinal pathology (e.g., disc herniation, spondylolisthesis)
  • Currently receiving physiotherapy treatment / taking analgesics
  • Contraindications to exercise
  • Nomal vaginal delivery women

Treatment and study plan

Therapeutic Exercise

Behavioral

Participants will receive a structured therapeutic exercise program through tele-rehabilitation. The exercises will be performed at home under remote guidance and supervision. The program is designed to reduce low back pain and fatigue and improve functional ability among postpartum women following cesarean section.

Ergonomic Education

Behavioral

Participants will receive ergonomic education focused on posture correction and back care during the postpartum period. Education will include appropriate breastfeeding posture, sitting and standing mechanics, safe lifting and carrying techniques, and strategies to reduce strain on the lower back during daily activities.

Primary outcomes

  1. Low Back Pain Intensity measured by Visual Analog Scale (VAS)

    Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)

    Low back pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Lower scores indicate lower pain intensity. The VAS will be used to assess changes in low back pain following the intervention.

  2. Fatigue Severity measured by Fatigue Severity Scale (FSS)

    Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)

    Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), which evaluates the impact of fatigue on daily functioning. Higher scores indicate greater fatigue severity. Changes in FSS scores will be assessed before and after the intervention.

  3. Psychological Well-being measured by WHO-5 Well-Being Index

    Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)

    Psychological well-being will be assessed using the WHO-5 Well-Being Index. Higher scores indicate better psychological well-being. Changes in psychological well-being will be assessed before and after the intervention.

Secondary outcomes

  1. Functional Disability measured by Oswestry Disability Index (ODI)

    Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)

    Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). Higher scores indicate greater functional disability. Changes in functional disability will be assessed before and after the intervention.

Sponsors and collaborators

Lead sponsor

Shifa Tameer-e-Millat University

Other

Registry information

Acronym: TELEREHAB-LBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 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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