Low Back PainTELEREHAB-LBPNCT07777731
Effect of Tele-Rehabilitation on Low Back Pain, Fatigue, and Psychological Well-being in Postpartum Women Following C-Section
A study testing Therapeutic Exercise and Ergonomic Education in people with Low Back Pain and Postpartum Fatigue, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Low Back Pain, Postpartum Fatigue, Psychological Well-being
- What is being tested?
- Therapeutic Exercise and Ergonomic Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences (PIMS)
Islamabad, Punajb, 44000
About this study
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:
Read more
- 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.
- Being tested
- Therapeutic Exercise, Ergonomic Education
- Keywords
- Postpartum low back pain, Cesarean section, Postpartum women, Tele-rehabilitation, Therapeutic exercise, Ergonomic education, Postpartum fatigue, Psychological well-being, Functional disability
- Medical subject headings
- Low Back Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Rehabilitation Group | Experimental | 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. Receives: Behavioral: Therapeutic Exercise; Behavioral: Ergonomic Education |
| Ergonomic Education Group | Active comparator | 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. Receives: Behavioral: Ergonomic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
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.
Measured: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
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.
Measured: 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.
Measured: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start4 May 2026
- Primary completion21 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two parallel groups. The intervention group will receive tele-rehabilitation combining therapeutic exercises and ergonomic education, while the control group will receive ergonomic education alone. Both groups will undergo pre-treatment and post-treatment assessments, and outcomes will be compared between the groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouzia Batool, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777731
- Sponsor's protocol ID
- 053-26
- Acronym
- TELEREHAB-LBP
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tele-Rehabilitation on Low Back Pain, Fatigue, and Psychological Well-being in Postpartum Women Following C-Section
- ClinicalTrials.gov ID
- NCT07777731
- Acronym / sponsor ID
- TELEREHAB-LBP / 053-26
- Keywords
- Postpartum low back pain, Cesarean section, Postpartum women, Tele-rehabilitation, Therapeutic exercise, Ergonomic education, Postpartum fatigue, Psychological well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two parallel groups. The intervention group will receive tele-rehabilitation combining therapeutic exercises and ergonomic education, while the control group will receive ergonomic education alone. Both groups will undergo pre-treatment and post-treatment assessments, and outcomes will be compared between the groups.
| Arm | Type | Receives |
|---|---|---|
| Tele-Rehabilitation Group | Experimental | Behavioral: Therapeutic Exercise, Behavioral: Ergonomic EducationParticipants 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. |
| Ergonomic Education Group | Active comparator | Behavioral: Ergonomic EducationParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Postpartum women between 2-6 weeks after delivery
Key exclusion criteria (6 listed)
- • Postpartum complications (e.g., infection, delayed healing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic ExerciseParticipants 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. | Behavioural | Tele-Rehabilitation Group |
| Ergonomic EducationParticipants 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. | Behavioural | Ergonomic Education Group, Tele-Rehabilitation Group |
Primary outcome
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.
Fatigue Severity measured by Fatigue Severity Scale (FSS)
Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
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.
Psychological Well-being measured by WHO-5 Well-Being Index
Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
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.
1 secondary outcome
Functional Disability measured by Oswestry Disability Index (ODI)
Time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise and Ergonomic Education in people with Low Back Pain and Postpartum Fatigue, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain Intensity measured by Visual Analog Scale (VAS) (time frame: Baseline (pre-treatment) and immediately after completion of the intervention (post-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.