NCT06756685

Brief Summary

The study aims to compare the effects of core strengthening versus motor control training on pain, disability \& endurance in patients with low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

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

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 13, 2024

Last Update Submit

August 24, 2025

Conditions

Keywords

back paindisabilityendurancecore strengtheningmotor control

Outcome Measures

Primary Outcomes (6)

  • Goniometer

    A goniometer will be used to measure ranges of motion of Trunk in Flexion, Extension, lateral Flexion and Rotation

    8 weeks

  • Lower body strength

    One-repetition maximum (1-RM) leg press at 70% 1-RM will be used to evaluate lower body strength.

    8 weeks

  • Modified Oswestry disability index

    The Oswestry Disability Index is considered one of the best accepted tools for assessment of low back pain. It is a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in chronic low back pain. The ODI is made up of 10 items. Each item consist of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. ODI = (Sum of items scored/Sum of sections answered) X 100

    8 weeks

  • Tampa scale of kinesiophobia

    The Tampa Scale of Kinesiophobia (TSK) was first developed in 1991 by R. Miller, S. Kopri, and D. Todd. A self-reported questionnaire that quantifies fear of movement, or (re)injury.It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree).The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.Scores above 37 (17-item) are generally considered to indicate kinesiophobia.

    8 weeks

  • Visual analog scale

    The pain VAS is a uni dimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Test-retest reliability has been shown to be good and moderate to good reliability for disability in patients with chronic musculoskeletal pain.

    8 weeks

  • Japanese orthopedic association back pain evaluation questionnaire

    The JOABPEQ includes twenty-five questions that are subdivided into five sub scales: lower back pain, lumbar function, walking ability, social life function, and mental health. These questions are Intended to evaluate individuals with low back pain from five different perspectives.scores range from 0 to 100, with higher scores indicating a better patient condition. Both kappa and weighted kappa were more than 0.50 for all but one item, which was 0.48.

    8 weeks

Study Arms (2)

Core Strengthening Exercises

EXPERIMENTAL

Core Strengthening Exercises

Other: Core Strengthening Exercises

Motor Control Training

ACTIVE COMPARATOR

Motor Control Training

Other: Motor Control Training

Interventions

The Core Strengthening Program participants will have supervised gym-based sessions for 8 weeks. In the first 4 weeks , participants will attend two 1 hour training sessions, followed by self-selected one or two sessions per week. The session will begin with 20min of aerobic conditioning of walking or running on a treadmill, starting at 65% and moving to 85% of HR max. The 5 key elements of focus are i. Centering ii. Breathing iii. Head and neck placement iv. Shoulder placement v. Chest wall placement

Core Strengthening Exercises

Participants in Motor Control group will receive two physiotherapy sessions of 1hour / week in the first 4 weeks, during stage 1. i. Abdominal drawing-in maneuver (ADIM) : isometric contraction of the local stability muscles (e.g., lumbar multifidus, transversus abdominis) in minimally loading positions (supine lying, quadruped, sitting, and standing) by maintaining a neutral spine while maintaining normal breathing. During Phase 2, One 1 hour session / week in the second 4 weeks. Activation and facilitation of transversus abdominis, lumbar multifidus and pelvic floor motor control(36).Exercises target the transversus abdominis, multifidus and pelvic floor muscles plus postural correction to restore optimal motor control during non-weight-bearing activities. Exercises and progressions will follow previous protocols of motor control exercise.

Motor Control Training

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-specific Chronic low back pain (\>3 months)
  • Pain between the T12 vertebra and gluteal fold with pain of 2-8 on the numerical rating scale of 0-10
  • Both Genders
  • Age of 25 and above

You may not qualify if:

  • Participants fall in this category would be excluded of the study.
  • Lumbar radiculopathy
  • Structural scoliosis
  • Traumatic spinal injury
  • Cauda equina syndrome
  • History of seizures, epilepsy, stroke or head injury
  • Metal implants
  • Pregnancy or considering pregnancy in near future
  • Body mass \>/= 100kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mediplex Health Care Center

Rawalpindi, Punjab Province, 46060, Pakistan

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sabiha Fayyaz, MS-NMPT*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2024

First Posted

January 3, 2025

Study Start

August 7, 2024

Primary Completion

January 1, 2025

Study Completion

January 10, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations