- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484594
Integrated Trunk Stabilization With Osteoarthritis Rehabilitation in Knee-Spine Syndrome
April 30, 2026 updated by: Riphah International University
Integrating Trunk Stabilization Exercises With Conventional Rehabilitation Protocol for Osteoarthritis in Patients With Knee-Spine Syndrome
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the effects of integrating trunk stabilization exercises with conventional rehabilitation protocols for patients with knee-spine syndrome.
It seeks to determine whether improving trunk stability can positively influence knee joint mechanics, leading to a reduction in knee pain and improvements in physical function, mobility, and overall functional performance in individuals with knee osteoarthritis.
The findings may support a more comprehensive rehabilitation approach addressing both spinal and knee involvement in osteoarthritis management.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Suman Sheraz, PhD
- Phone Number: 03335646361 03335646361
- Email: suman.sheraz@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PhD
- Phone Number: 03324390125 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
-
Rawalpindi, Pakistan
- Bahria Active
-
Contact:
- Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
-
Contact:
- Suman Sheraz, PhD
- Phone Number: 03335646361 03335646361
- Email: suman.sheraz@riphah.edu.pk
-
Sub-Investigator:
- Tooba Rauf, MS-OMPT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trunk Stabilization exercises with conventional Rehab
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 :
|
The protocol for will be followed for 6 weeks, where individuals will perform trunk stabilization exercises with conventional rehabilitation for knee osteoarthritis.
|
|
Other: Conventional Rehabilitation
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.
|
The protocol for will be followed for 6 weeks, where conventional rehabilitation for knee osteoarthritis will be implemented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 6 weeks
|
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)
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range Of motion (ROM)
Time Frame: 6 weeks
|
A Goniometer is used to measure active and passive ROM for knee flexion and extension while the patient lies supine
|
6 weeks
|
|
Flexicurve (Lumbar Range of motion)
Time Frame: 6 weeks
|
Flexicurve is a flexible plastic-coated metal ruler molded to the lumbar spine's sagittal contour (typically T12 to S1) to non-invasively measure lordosis angle via traced perpendicular heights, serving as a radiation-free alternative to X-rays
|
6 weeks
|
|
Time-Up-and-Go (TUG)
Time Frame: 6 weeks
|
This test is a widely used assessment of functional mobility, particularly in patients with knee osteoarthritis.
The test measures the total time it takes for a patient to stand up from a chair, walk 3 meters at a comfortable pace, turn around, walk back to the chair, and sit down.
A shorter time indicates better functional performance
|
6 weeks
|
|
Oswestry Disability Index (ODI)
Time Frame: 6 weeks
|
It is a questionnaire that gives a subjective percentage score of level of function/disability in activities of daily living of patients with low back pain.
It contains 10 items, each scored from 0 to 5, with the total score converted to a percentage ranging from 0% to 100%.
Higher percentages indicate greater disability, i.e., worse outcomes, while lower percentages indicate less disability/better outcomes.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suman Sheraz, PhD, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
July 15, 2026
Study Completion (Estimated)
August 15, 2026
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 16, 2026
First Posted (Actual)
March 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tooba Rauf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
Clinical Trials on Trunk Stabilization exercises with conventional Rehab
-
Ahi Evran University Education and Research HospitalRecruitingCore Exercises Training | Rotator Cuff Injury (RCI)Turkey (Türkiye)
-
Riphah International UniversityCompleted
-
Riphah International UniversityRecruitingCerebral Palsy Spastic DiplegiaPakistan
-
Lahore University of Biological and Applied SciencesRecruiting
-
University of Social Welfare and Rehabilitation...CompletedLow Back PainIran, Islamic Republic of
-
University of VermontEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Riphah International UniversityCompletedScapular DyskinesisPakistan
-
Riphah International UniversityNot yet recruitingAdhesive CapsulitisPakistan
-
Başakşehir Çam & Sakura City HospitalActive, not recruitingStrokeTurkey (Türkiye)