NCT06914271

Brief Summary

Low back pain (LBP) is pain, muscle tension, or stiffness under the costal border and above the inferior gluteal folds, with or without leg pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    The Visual Analogue Scale (VAS) is a way of measuring pain intensity. It is often utilized in investigations concerning pain management. Visual analog scales (VAS) are psychometric measuring tools created to record the characteristics of disease-related symptom severity in individual patients and utilize this to achieve a quick (statistically observable and reproducible) classification of symptom severity and disease control. Scores are taken by placing a handwritten mark along a 10-cm line that depicts a pain spectrum between ""no pain"" and ""worst pain.""

    12 Months

  • Oswestry Disability Index (ODI)

    The Oswestry Disability Index (ODI) is a widely used instrument for determining the degree of impairment and how low back pain affects a person's ability to do daily chores. Each of its 10 sections focuses on a different aspect of everyday life, such as pain severity, personal cleanliness, walking, lifting, sitting, standing, sleeping, and social life. A person's scores for each component are added based on the severity of their condition to determine their total disability percentage, which can range from 0% (no impairment) to 100% (severe disability). It is widely used in clinical settings to track changes over time and assess the effectiveness of treatments for low back pain (27). The Oswestry Disability Index (ODI) exhibits great validity (correlation with VAS: r= 0.67; Roland Morris: r=0.76) and high reliability (Cronbach's α \> 0.70, ICC \> 0.90)

    12 Months

  • Goniometer

    A Goniometer is simple yet effective tool used to measure the range of motion of a joint. 0% to 20%: minimal disability: 21%-40%: moderate disability: 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.

    12 Months

Study Arms (2)

Kendall Exercise

EXPERIMENTAL
Combination Product: Kendall Exercise

Kabat Exercises

ACTIVE COMPARATOR
Combination Product: Kabat Exercises

Interventions

Kendall ExerciseCOMBINATION_PRODUCT

The Kendall Exercises focus on correcting posture, strengthening the core, and re-educating muscles to improve spinal alignment and reduce pain .These exercises primarily target specific muscles and joint actions to help patients regain their range of motion.

Kendall Exercise
Kabat ExercisesCOMBINATION_PRODUCT

The principle of the Kabat exercises is based on a series of neuromuscular facilitation techniques that emphasize dynamic movement patterns, flexibility, and coordination to enhance functional mobility and alleviate pain.

Kabat Exercises

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both Genders
  • Adults Aged Between 30-65
  • Low Back pain should be Persistent for more than 12 weeks
  • Visual Analogue scale or VAS of 3 or higher
  • Idiopathic pain
  • Ability to engage in physical activity and participate in the intervention program
  • Willingness and ability to provide informed consent to participate in the study

You may not qualify if:

  • Low back pain due to other causes
  • Fibromyalgia
  • Previous spine surgery
  • Spondylolisthesis
  • Spondylolysis
  • Rheumatoid arthritis or Ankylosing spondylitis
  • Spinal inflammation or tumor
  • Spinal or pelvis fracture
  • Osteoporosis
  • Respiratory or heart diseases
  • Stroke
  • Pregnancy
  • Persistent use of pain medication
  • Patients who had undergone any other treatments, such as acupuncture or physical therapy, in the last 3 months
  • Anticipated inability to comply with study protocols or attend scheduled."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Younas hospital daska

Sialkot, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations