Low Back PainKCT-PLBPNCT07105683
Effect of Kinetic Control Training on Postnatal Low Back Pain
A study testing hot pack therapy in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
the effect of kinetic control training and hotpack and compare it with hotpack alone on postnatal low back pain Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- hot pack therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients with postnatal low back pain (PLBP) that lasted for at least 6 months.
- Pain intensity ≥ 5 on the Visual Analog Scale (VAS).
- Limitation score ≤ 5 on the Modified Schober Test.
- Age between 25 and 35 years.
- Body mass index (BMI) between 20-25 kg/m².
- Medically stable and able to provide informed consent.
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- Positive result in the extension uncontrolled movement test, indicating:
- Loss of lumbopelvic control.
- Overactivity of global extensors during functional tasks. *Exclusion Criteria:**
- Any neurological or rheumatological disorders.
- Previous spinal surgery.
- Pregnancy or planning to become pregnant during the study period.
- BMI outside the 20-25 kg/m² range.
- Inability to participate in exercise or physical activity.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
dr mohamed awad and dr marwa mahran prof and doctor, phd /master contact
About this study
the effect of kinetic control training and hotpack and compare it with hotpack alone on postnatal low back pain
Read the detailed description
Background: Postnatal low back pain (PLBP) is a common condition affecting women after childbirth due to musculoskeletal and biomechanical changes during pregnancy. Effective rehabilitation strategies are essential for pain relief and functional recovery.
Objective: This study aims to evaluate the effect of kinetic control training in postnatal women with low back pain.
Methods: A total of 66 postnatal women with low back pain were randomly selected from WENGAT Hospital and EL SHATBY Hospital in Alexandria. Participants were divided into two equal groups:
Group A: 33 women treated with hot pack for 20 minutes twice daily for 6 weeks. Group B: 33 women treated with a combination of kinetic control training and hot pack 3 sessions/week for 6 weeks.
Pain intensity will be assessed using the Visual Analog Scale (VAS) and Pressure Algometer. Range of motion (ROM) will be evaluated using the Modified Schober Test.
- Conditions
- Low Back Pain
- Being tested
- hot pack therapy, Kinetic control training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot pack therapyOther
Application of a commercial hot pack to the lumbar region for 20-30 minutes per session, twice daily, for 6 weeks.
Kinetic control trainingGenetic
is an evidence-based rehabilitation approach, focused on retraining movement patterns by addressing and improving motor control of the lumbar spine and pelvis, correcting faulty movement strategies, enhancing stability in functional tasks. The principles of KCT entail the identification of direction-specific motor control deficit, uncontrolled extension, followed by focused retraining of movement control through specific exercises designed to improve the coordination and activation of deep stabilizing muscle systems, including the transversus abdominis, multifidus, and pelvic floor muscles. This approach is especially relevant in postpartum women, where motor control deficits and poor load transfer capabilities are commonly observed . Based on the clinical presentation of patients with postnatal low back pain, demonstrated symptoms that were aggravated during lumbar extension movements or when maintaining prolonged upright postures. The
| Study group | Role | What they receive |
|---|---|---|
| Hot Pack Therapy Only (Control Group) | Active comparator | Participants in this arm receive hot pack therapy as a standard physiotherapeutic intervention. A moist hot pack is applied to the lumbar region for 20-30minutes per session, twice daily, over a period of 8weeks. This intervention is intended to provide superficial heat to reduce pain, promote muscle relaxation, and improve local circulation. No additional therapeutic exercises are administered to this group Receives: Other: hot pack therapy |
| Hot Pack Therapy + Kinetic Control Training (Experimental Group) | Experimental | Participants in this arm receive both hot pack therapy and kinetic control training. The hot pack is applied to the lumbar region for 20-30minutes per session, twice daily, for 8weeks. In addition, participants undergo kinetic control training, which includes therapist-guided exercises targeting the deep stabilizing muscles of the lumbar-pelvic region. Exercises focus on improving muscle coordination, movement control, and spinal stability. Sessions are conducted three times per week for 8 weeks. Receives: Other: hot pack therapy; Genetic: Kinetic control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool for measuring subjective pain levels. Participants will indicate their pain level on a 10 cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10). This measurement will help evaluate the effectiveness of kinetic control training in reducing postnatal low back pain compared to hot pack therapy alone
Measured: Baseline and after 8weeks of intervention
Secondary outcomes (1)
Lumbar Range of Motion (Flexion and Extension) Using Modified Schober Test
This measure assesses the flexibility and mobility of the lumbar spine using the Modified Schober Test. A non-invasive tape measure method is used to evaluate the difference in spinal segment length during full flexion and extension compared to the neutral standing posture. The outcome reflects the degree of lumbar mobility, which may be affected by postnatal low back pain and improved through targeted interventions like kinetic control training.
Measured: Baseline and after 8weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ahmed Mohammed, Cairo University
- Investigators
- Mohammed Fawzy, Phd, Principal investigator, Om el masryen hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105683
- Sponsor's protocol ID
- P.T.REC/012/005122
- Other IDs
- P.T.REC/012/005122
- Acronym
- KCT-PLBP
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan for sharing deidentified individual participant data is under consideration. It will depend on institutional policies and ethical approvals. Further details will be provided once finalized.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Control Training on Postnatal Low Back Pain
- ClinicalTrials.gov ID
- NCT07105683
- Acronym / sponsor ID
- KCT-PLBP / P.T.REC/012/005122
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 6 Aug 2025 (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 effect of kinetic control training and hotpack and compare it with hotpack alone on postnatal low back pain
Detailed description
Background: Postnatal low back pain (PLBP) is a common condition affecting women after childbirth due to musculoskeletal and biomechanical changes during pregnancy. Effective rehabilitation strategies are essential for pain relief and functional recovery.
Objective: This study aims to evaluate the effect of kinetic control training in postnatal women with low back pain.
Methods: A total of 66 postnatal women with low back pain were randomly selected from WENGAT Hospital and EL SHATBY Hospital in Alexandria. Participants were divided into two equal groups:
Group A: 33 women treated with hot pack for 20 minutes twice daily for 6 weeks. Group B: 33 women treated with a combination of kinetic control training and hot pack 3 sessions/week for 6 weeks.
Pain intensity will be assessed using the Visual Analog Scale (VAS) and Pressure Algometer. Range of motion (ROM) will be evaluated using the Modified Schober Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot Pack Therapy Only (Control Group) | Active comparator | Other: hot pack therapyParticipants in this arm receive hot pack therapy as a standard physiotherapeutic intervention. A moist hot pack is applied to the lumbar region for 20-30minutes per session, twice daily, over a period of 8weeks. This intervention is intended to provide superficial heat to reduce pain, promote muscle relaxation, and improve local circulation. No additional therapeutic exercises are administered to this group |
| Hot Pack Therapy + Kinetic Control Training (Experimental Group) | Experimental | Other: hot pack therapy, Genetic: Kinetic control trainingParticipants in this arm receive both hot pack therapy and kinetic control training. The hot pack is applied to the lumbar region for 20-30minutes per session, twice daily, for 8weeks. In addition, participants undergo kinetic control training, which includes therapist-guided exercises targeting the deep stabilizing muscles of the lumbar-pelvic region. Exercises focus on improving muscle coordination, movement control, and spinal stability. Sessions are conducted three times per week for 8 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Female patients with postnatal low back pain (PLBP) that lasted for at least 6 months.
- Pain intensity ≥ 5 on the Visual Analog Scale (VAS).
- Limitation score ≤ 5 on the Modified Schober Test.
- Age between 25 and 35 years.
- Body mass index (BMI) between 20-25 kg/m².
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hot pack therapyApplication of a commercial hot pack to the lumbar region for 20-30 minutes per session, twice daily, for 6 weeks. | Other | Hot Pack Therapy + Kinetic Control Training (Experimental Group), Hot Pack Therapy Only (Control Group) |
| Kinetic control trainingis an evidence-based rehabilitation approach, focused on retraining movement patterns by addressing and improving motor control of the lumbar spine and pelvis, correcting faulty movement strategies, enhancing stability in functional tasks. The principles of KCT entail the identification of direction-specific motor control deficit, uncontrolled extension, followed by focused retraining of movement control through specific exercises designed to improve the coordination and activation of deep stabilizing muscle systems, including the transversus abdominis, multifidus, and pelvic floor muscles. This approach is especially relevant in postpartum women, where motor control deficits and poor load transfer capabilities are commonly observed . Based on the clinical presentation of patients with postnatal low back pain, demonstrated symptoms that were aggravated during lumbar extension movements or when maintaining prolonged upright postures. The | Genetic | Hot Pack Therapy + Kinetic Control Training (Experimental Group) |
Primary outcome
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline and after 8weeks of intervention
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool for measuring subjective pain levels. Participants will indicate their pain level on a 10 cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10). This measurement will help evaluate the effectiveness of kinetic control training in reducing postnatal low back pain compared to hot pack therapy alone
1 secondary outcome
Lumbar Range of Motion (Flexion and Extension) Using Modified Schober Test
Time frame: Baseline and after 8weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Official study information page hosted by Cairo University.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The plan for sharing deidentified individual participant data is under consideration. It will depend on institutional policies and ethical approvals. Further details will be provided once finalized.
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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.
dr mohamed awad and dr marwa mahran prof and doctor, phd /master contact
Mohammed Fawzy, Phd principal investigator
Om el masryen hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot pack therapy in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
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 14 inclusion and 0 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: opening soon, as of the sponsor's last update on 6 Aug 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr mohamed awad and dr marwa mahran prof and doctor, phd /master (01224955140 ext. 01276597490, awad18111972@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline and after 8weeks of intervention). 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 6 Aug 2025.