Effectiveness of Stanley Paris Manual Therapy vs. Conventional Physiotherapy in Reducing Pain and Improving Function in Grade II Knee Osteoarthritis

NCT ID: NCT07317375

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2025-12-25

Brief Summary

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.

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.

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.

Intervention Type: OTHER

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.

Interventions

Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.

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.

Intervention Type: OTHER

Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.

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.

Intervention Type: OTHER

Other Intervention Names

Manual Therapy; Stanley Paris Approach; joint Mobilization and Movement Re-education; Routine Physiotherapy; Standard Physical Therapy; Exercise and Electrotherapy Program

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helping Hand Institute of Rehabilitation Sciences

OTHER

Sponsor Role: collaborator

Ibadat International University, Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Dr Abdul Haseeb Bhutta

ASSISTANT PROFESSOR / HOD PHYSICAL THERAPY DEPARTMENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Dr. Muhammad Nazim Farooq, Ph.D.

Role: STUDY_DIRECTOR

Ibadat International University, Islamabad

Locations

Ibadat international University islamabad

Islamabad, Federal, Pakistan

Countries

Pakistan

Other Identifiers

IIUI/RERC/ADT/2025/07/178-1

Identifier Type: -

Identifier Source: org_study_id