- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317375
Effectiveness of Stanley Paris Manual Therapy vs. Conventional Physiotherapy in Reducing Pain and Improving Function in Grade II Knee Osteoarthritis (SPMT vs CPT in)
Effectiveness of Stanley Paris Manual Therapy Concept Versus Conventional Physiotherapy in Pain Reduction and Functional Improvement in Grade II Knee Osteoarthritis
This study aims to compare two different physiotherapy approaches for people suffering from Grade II Knee Osteoarthritis (OA) - a condition that causes knee pain, stiffness, and difficulty in walking.
The first approach is the Stanley Paris Manual Therapy Concept, which involves hands-on treatment techniques such as joint mobilization, soft tissue massage, and movement correction. The second is Conventional Physiotherapy, which uses traditional exercises and electrotherapy (like heat, ultrasound, or TENS) to reduce pain and improve strength.
The study will include 50 patients aged 40-60 years who have moderate knee osteoarthritis. They will be randomly divided into two groups - one receiving manual therapy and the other receiving conventional physiotherapy - for 6 to 8 weeks.
Researchers will measure pain, knee function, range of motion, balance, and quality of life before and after treatment to see which method gives better results.
By identifying which therapy works more effectively, this study will help patients, families, and healthcare providers choose the most beneficial and evidence-based treatment for improving movement, reducing pain, and enhancing daily living activities in people with knee osteoarthritis.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.
- Other: Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.
Detailed Description
Knee osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and loss of mobility, often leading to functional limitations and reduced quality of life. In Grade II OA, cartilage damage is moderate and potentially reversible through appropriate rehabilitation strategies. This stage offers an important opportunity for physiotherapy interventions to restore function and delay further joint deterioration.
The Stanley Paris Manual Therapy Concept emphasizes a biomechanical and hands-on approach to rehabilitation. It includes joint mobilization, soft tissue manipulation, neural mobilization, and correction of faulty movement patterns to restore normal joint motion and neuromuscular control. In contrast, Conventional Physiotherapy typically focuses on pain management using electrotherapy modalities, strengthening exercises, and general mobility training.
This randomized controlled trial (RCT) is designed to compare the effectiveness of these two treatment approaches in individuals with Grade II knee osteoarthritis. Fifty participants will be randomly allocated into two equal groups: one receiving the Stanley Paris manual therapy and the other receiving conventional physiotherapy, for a period of 6-8 weeks. Standardized assessment tools - including the Visual Analog Scale (VAS) for pain, the Knee Injury and Osteoarthritis Outcome Score (KOOS) for function and quality of life, and the Berg Balance Scale for proprioception and stability - will be used to evaluate outcomes at baseline, mid-intervention, and post-intervention.
The study will generate clinical evidence on whether manual therapy provides superior outcomes in terms of pain relief, functional improvement, and patient satisfaction compared to conventional physiotherapy. Results are expected to assist clinicians in developing more effective rehabilitation protocols for managing knee osteoarthritis and improving patients' independence and overall well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan
- Ibadat international University islamabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with Grade II knee osteoarthritis based on radiographic and clinical criteria.
- Participants experiencing knee pain for at least three months.
- Ability to walk independently without assistive devices.
- Willingness to participate in a structured physiotherapy program.
Exclusion Criteria:
- Presence of Grade III or IV knee osteoarthritis.
- History of knee surgery or joint replacement.
- Rheumatoid arthritis or other inflammatory joint diseases.
- Neurological conditions affecting lower limb function.
- Contraindications to manual therapy or exercise interventions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stanley Paris group
Participants in this group will receive treatment based on the Stanley Paris Manual Therapy Concept, which emphasizes hands-on techniques to restore joint biomechanics and improve movement patterns.
Interventions will include joint mobilization (Maitland and Kaltenborn grades II-IV), soft tissue and myofascial release, neural mobilization, proprioceptive training, and functional movement retraining.
Sessions will be conducted 4 times per week for 6 weeks by trained physiotherapists following a standardized treatment protocol.
|
This intervention follows the Stanley Paris Manual Therapy Concept, a hands-on approach emphasizing biomechanical correction and functional movement restoration.
Treatment will include Maitland and Kaltenborn joint mobilization (Grades II-IV), patellar glides, soft tissue and myofascial release, neural mobilization, and movement pattern retraining.
Sessions will also include proprioceptive and balance exercises, functional strengthening, and patient education on posture and joint protection.
Each participant will receive 4 sessions per week for 6 weeks, lasting approximately 45-60 minutes each, delivered by trained manual therapists using a standardized protocol.
Other Names:
|
|
Active Comparator: Conventional Physical Therapy
Participants in this group will receive Conventional Physiotherapy, including electrotherapy modalities (TENS, ultrasound, heat/cold therapy), general strengthening exercises, range-of-motion and flexibility exercises, and basic balance training.
The focus will be on pain reduction, muscle strengthening, and functional mobility improvement.
Sessions will also be conducted 4 times per week for 6 weeks following standard clinical practice guidelines for knee osteoarthritis management.
|
This intervention consists of standard physiotherapy treatment commonly used for Grade II Knee Osteoarthritis.
It includes electrotherapy modalities such as TENS, ultrasound, and hot/cold therapy, along with therapeutic exercises for strengthening, flexibility, and balance.
Exercises include open-chain and closed-chain strengthening, range-of-motion activities, and static stretching.
Participants will receive 4 supervised sessions per week for 6 weeks, each lasting 45-60 minutes, administered by qualified physiotherapists following evidence-based clinical practice guidelines.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Reduction Measured by Visual Analog Scale (VAS)
Time Frame: Change in pain intensity from baseline to 4th week and 8 weeks
|
The Visual Analog Scale (VAS) will be used to assess the intensity of knee pain.
Participants will mark their pain level on a 10 cm line ranging from 0 ("no pain") to 10 ("worst imaginable pain").
Pain scores will be recorded at baseline, after 4 weeks, after 8 weeks of treatment.
|
Change in pain intensity from baseline to 4th week and 8 weeks
|
|
Functional Improvement Measured by Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Change in KOOS scores from baseline to 4th weeks and 8 weeks.
|
The KOOS questionnaire will assess knee function, daily living activities, sports and recreation function, and knee-related quality of life.
Each subscale is scored from 0 (extreme problems) to 100 (no problems).
|
Change in KOOS scores from baseline to 4th weeks and 8 weeks.
|
|
Knee Range of Motion Measured by Goniometer
Time Frame: Change from baseline to 4th weeks and 8 weeks post-intervention.
|
Active knee flexion and extension will be measured using a standard universal goniometer to assess joint mobility.
|
Change from baseline to 4th weeks and 8 weeks post-intervention.
|
|
Balance and Proprioception Measured by Berg Balance Scale
Time Frame: Change from baseline to 4th week and 8 weeks post-intervention.
|
The Berg Balance Scale (14 items, score range 0-56) will assess participants' static and dynamic balance.
Higher scores indicate better balance and lower fall risk.
|
Change from baseline to 4th week and 8 weeks post-intervention.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Prof. Dr. Muhammad Nazim Farooq, Ph.D., Ibadat International University, Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Mechanical Phenomena
- Physical Phenomena
- Rehabilitation
- Anesthesia and Analgesia
- Radiation
- Radiation, Nonionizing
- Electric Stimulation Therapy
- Analgesia
- Ultrasonic Waves
- Sound
- Exercise
- Musculoskeletal Manipulations
- Transcutaneous Electric Nerve Stimulation
- High-Energy Shock Waves
- Pliability
Other Study ID Numbers
- IIUI/RERC/ADT/2025/07/178-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Osteoarthritis (OA) of the Knee
-
Middlesex UniversityRecruitingOsteoarthritis | Osteoarthritis (OA) | Osteoarthritis (OA) of the Knee | Osteoarthritis (OA) of the HipUnited Kingdom
-
University of UtahRecruitingTendinopathy | Osteoarthritis (OA) | Elbow Osteoarthritis | Osteoarthritis (OA) of the Knee | Epicondylitis of the Elbow | Osteoarthritis Ankle | Plantar Fasciitis of Both Feet | Osteoarthritis (OA) of the Shoulder | Osteoarthritis (OA) of the HipUnited States
-
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
-
Ankara City Hospital BilkentRecruitingOsteoarthritis (OA) of the KneeTurkey (Türkiye)
-
Wu zenanThe Affiliated Hospital of Jiangxi University of Traditional Chinese MedicineRecruitingOsteoarthritis | Osteoarthritis of the Knees | Osteoarthritis (OA) of the KneeChina
-
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
-
Allegheny Singer Research Institute (also known...Not yet recruitingKnee Arthroplasty, Total | Osteoarthritis (OA) | Osteoarthritis (OA) of the Knee | Periarticular Block | Pain After Surgery
-
University of LahoreNot yet recruitingOsteoarthritis (OA) of the Knee | OsteoarthitisPakistan
-
Uludag UniversityUludag University HospitalCompletedOsteoarthritis | Osteoarthritis (OA) of the Knee | Knee OATurkey
-
Thammasat UniversityThammasat University HospitalCompletedOsteoarthritis (OA) of the Knee | OA KneeThailand
Clinical Trials on Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.
-
Universitat Internacional de CatalunyaCompletedTennis Elbow | Physical Therapy ModalitiesSpain