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

NCT07317375 | Completed DMC

• 1 other identifier: IIUI/RERC/ADT/2025/07/178-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

osteoarthritis; knee; Stanley Paris

Outcome Measures

Primary Outcomes (4)

• Pain Reduction Measured by Visual Analog Scale (VAS)

  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)

  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

  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

  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.

Study Arms (2)

Stanley Paris group

EXPERIMENTAL

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.

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

Conventional Physical Therapy

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: Manual Therapy, Stanley Paris Approach, joint Mobilization and Movement Re-education

Stanley Paris group

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

Also known as: Routine Physiotherapy, Standard Physical Therapy, Exercise and Electrotherapy Program

Conventional Physical Therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead
• Helping Hand Institute of Rehabilitation Sciences: collaborator

Study Sites (1)

Ibadat international University islamabad

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Musculoskeletal Manipulations; Transcutaneous Electric Nerve Stimulation; High-Energy Shock Waves; Pliability; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Mechanical Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

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

  Ibadat International University, Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will use a quadruple-blind design in which the participants, care providers, investigators, and outcomes assessors will all be masked to group allocation. Randomization will be conducted using a coded allocation system managed by an independent coordinator. Intervention protocols will be standardized and labeled by code to ensure blinding of treatment identity. Data collection and analysis will be performed without revealing group assignments to maintain objectivity and reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR / HOD PHYSICAL THERAPY DEPARTMENT

Model Details: This study is a randomized controlled trial with a parallel-group design involving 50 participants diagnosed with Grade II Knee Osteoarthritis. Participants will be randomly assigned into two groups: Group A will receive the Stanley Paris Manual Therapy Concept, and Group B will receive Conventional Physiotherapy. Both groups will undergo supervised sessions 2-3 times per week for 6-8 weeks. Randomization will be computer-generated, and outcome assessors will be blinded to group allocation. The study follows a prospective, single-blinded, two-arm model, comparing manual therapy-based rehabilitation with traditional physiotherapy for pain reduction, functional improvement, and enhanced quality of life in knee osteoarthritis patients.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: August 5, 2025
• Primary Completion: November 25, 2025
• Study Completion: December 25, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: February 2026
• Access Criteria: On demand IPD will be shared with journals editor

Locations

PA (1)