NCT07105683

Brief Summary

the effect of kinetic control training and hotpack and compare it with hotpack alone on postnatal low back pain

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

15 days

First QC Date

July 4, 2025

Last Update Submit

August 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and after 8weeks of intervention

Secondary Outcomes (1)

  • Lumbar Range of Motion (Flexion and Extension) Using Modified Schober Test

    Baseline and after 8weeks of intervention

Study Arms (2)

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

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.

Other: hot pack therapyGenetic: Kinetic control training

Interventions

Application of a commercial hot pack to the lumbar region for 20-30 minutes per session, twice daily, for 6 weeks.

Hot Pack Therapy + Kinetic Control Training (Experimental Group)Hot Pack Therapy Only (Control Group)

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

Hot Pack Therapy + Kinetic Control Training (Experimental Group)

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details\*\*Inclusion Criteria:\*\* * 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. * 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Positive result in the extension uncontrolled movement test, indicating:
  • Loss of lumbopelvic control.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

physical therapy cairo University

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammed Fawzy, Phd

    Om el masryen hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

dr mohamed awad and dr marwa mahran prof and doctor, phd /master

CONTACT

Marwa Mahran, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 4, 2025

First Posted

August 6, 2025

Study Start

August 10, 2025

Primary Completion

August 25, 2025

Study Completion

September 15, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations