NCT07484594

Brief Summary

This study aims to evaluate the effects of integrating trunk stabilization exercises with conventional rehabilitation in patients with knee-spine syndrome. It further examines whether improving trunk stability can reduce knee pain and enhance functional outcomes in knee osteoarthritis

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable knee-osteoarthritis

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

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Study Timeline

Key milestones and dates

Study Progress38%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Knee OsteoarthritisKnee-Spine SyndromeTrunk Exercise

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    The Visual Analog Scale (VAS) is a simple and reliable tool for assessing pain intensity on a continuous visual scale. The extreme limits of pain are represented by the straight line's ends, where 0 indicates no pain, and 10 indicates the worst pain a person has ever felt.

    6 weeks

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    It is widely used in the evaluation of knee osteoarthritis to assess activities of daily living, functional mobility, gait, general health, and quality of life. It has 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The scores range from 0 to 4 for each subscale. The score ranges from 0 to 96, where zero indicates no pain, stiffness, and functional limitation. Higher scores indicate worse pain, stiffness, and functional limitation.

    6 weeks

Secondary Outcomes (4)

  • Range Of motion (ROM)

    6 weeks

  • Time-Up-and-Go (TUG)

    6 weeks

  • Oswestry Disability Index (ODI)

    6 weeks

  • Flexicurve (Lumbar Range of motion)

    6 weeks

Study Arms (2)

Trunk Stabilization exercises with conventional Rehab

EXPERIMENTAL

The intervention will include the conventional knee osteoarthritis rehabilitation protocol comprising mobilization, stretching, and strengthening exercises, along with the following trunk stabilization exercises performed for 6 repetition followed by 30 second rest : 1. Prone extension 2. Back bridge 3. Unilateral back bridge 4. Sideways step-up 5. Bird dog

Other: Trunk Stabilization exercises with conventional Rehab

Conventional Rehabilitation

OTHER

The conventional rehabilitation protocol for knee osteoarthritis included Maitland's mobilization performed at a rate of 2-3 oscillations per second for 2 minutes, followed by stretching exercises held for 30 seconds across three sets. Muscle strengthening exercises were also incorporated, consisting of 10 repetitions with a 15-second hold, performed over four sets.

Other: Conventional Rehabilitation

Interventions

The protocol for will be followed for 6 weeks, where individuals will perform trunk stabilization exercises with conventional rehabilitation for knee osteoarthritis.

Trunk Stabilization exercises with conventional Rehab

The protocol for will be followed for 6 weeks, where conventional rehabilitation for knee osteoarthritis will be implemented.

Conventional Rehabilitation

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-60 years
  • Both Genders
  • Bilateral Knee osteoarthritis diagnosed according to the American College of Rheumatology Clinical Classification system
  • Kellgren \& Lawrence grade 2 and 3 with complaint of pain, crepitations, stiffness and bony enlargement
  • History of backpain for the past 3 months with no complaint of radiating pain
  • Able to walk independently/unaided

You may not qualify if:

  • Kellgren \& Lawrence grade 4
  • Intra-articular corticosteroid injections in the last 3 months or hyaluronic knee injection in the previous 6 months.
  • History of lower limb or lumbar trauma/surgery, presence of fracture or deformity, or planned surgery within the study period
  • Lumbar pathologies, for example, spondylolisthesis, ankylosing spondylitis, or any diagnosed severe cardiovascular, pulmonary, neurological, or psychological disease or impairment except lumbar spondylosis
  • BMI\>30
  • Presence of infection, cauda equina syndrome, or meningitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria Active

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Suman Sheraz, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations