ClinicalTrials.gg
CompletedNCT07777731TELEREHAB-LBPUpdated Sep 16, 2026

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

An interventional study of Therapeutic Exercise and Ergonomic Education in Low Back Pain, Postpartum Fatigue and Psychological Well-being, sponsored by Shifa Tameer-e-Millat University. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2026, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 223 studies in Low Back Pain with a site in Pakistan — 67 open to participants now, 79 under way, none of them phase 3. Low Back Pain · Pakistan.

Enrollment
176th of 216
30 · median 42
Started
2026
with 30 others
No phase
216 of 223
66 open now
Registered
213th of 223
by date

Among the 223 studies in Low Back Pain with a site in Pakistan, this one is the 176th largest by enrollment of the 216 interventional ones that give a count, is one of 31 that started in 2026, is one of 216 with no phase, and was the 213th registered.

Low Back Pain

2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.

Browse Low Back Pain studies →

Open to participants now

67 of the 223 studies in Low Back Pain with a site in Pakistan are open now. Recruiting first, the newest first:

62 more — sign in →

All 67 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 332 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 210 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.

This study: 20 Years to 40 Years · female · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Low Back Pain
  • Postpartum Fatigue
  • Psychological Well-being
  • Functional Disability

Keywords

  • Postpartum low back pain
  • Cesarean section
  • Postpartum women
  • Tele-rehabilitation
  • Therapeutic exercise
  • Ergonomic education
  • Postpartum fatigue
  • Psychological well-being
  • Functional disability
04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
      • to exercise
      • Nomal vaginal delivery women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Tele-Rehabilitation Group

    Participants will receive tele-rehabilitation combining therapeutic exercises and ergonomic education. Therapeutic exercises will be delivered remotely through WhatsApp video sessions, with participants receiving guidance and supervision during the exercise program. Ergonomic education will include posture correction and back-care advice related to breastfeeding, sitting, standing, lifting, carrying, and other daily activities. Participants will complete the intervention at home and will undergo outcome assessments before and after the treatment program.

    Behavioral: Therapeutic Exercise · Behavioral: Ergonomic Education

  • Active comparator
    Ergonomic Education Group

    Participants will receive ergonomic education focused on posture correction and back care during the postpartum period. Education will include guidance on appropriate breastfeeding posture, sitting and standing mechanics, safe lifting and carrying techniques, and strategies for reducing strain on the lower back during daily activities. Participants will receive the education remotely and will complete outcome assessments before and after the treatment program.

    Behavioral: Ergonomic Education

Interventions

  • BehavioralTherapeutic Exercise

    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.

  • BehavioralErgonomic Education

    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.

06

What researchers measure

Primary outcomes

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

    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.

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

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

    Description: Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), which consists of 9 items scored from 1 to 7, with a total score ranging from 9 to 63. Higher scores indicate greater fatigue severity (worse outcome). Changes in Fatigue Severity Scale scores will be assessed before and after the intervention.

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

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

    Description: Psychological well-being will be assessed using the World Health Organization-Five Well-Being Index (WHO-5). Each item is scored from 0 to 5, with a raw total score ranging from 0 to 25. The raw score may be converted to a percentage score ranging from 0 to 100. Higher scores indicate better psychological well-being (better outcome). Changes in World Health Organization-Five Well-Being Index scores will be assessed before and after the intervention.

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

Secondary outcomes

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

    Description: Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). The index consists of 10 sections, with each section scored from 0 to 5, giving a total score of 0 to 50, which can be expressed as a percentage from 0% to 100%. Higher scores indicate greater functional disability (worse outcome). Changes in Oswestry Disability Index scores will be assessed before and after the intervention.

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

07

Study locations

1 site
  • Pakistan Institute of Medical Sciences (PIMS)
    Islamabad, Punajb 44000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2026 to primary completion in Aug 2026, 3 months.

Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's 3 months is below that.

Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
May 4, 2026
Primary completionActual
Aug 21, 2026
CompletionActual
Aug 31, 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777731
Lead sponsor
Shifa Tameer-e-Millat University
Responsible party
Fouzia Batool (Assistant Professor, Shifa Tameer-e-Millat University) — Principal investigator
First posted
Aug 20, 2026
Start date
May 4, 2026
Primary completion
Aug 21, 2026
Completion
Aug 31, 2026
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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