Osteoarthritis (OA) of the KneeSPMT vs CPT inNCT07317375
Effectiveness of Stanley Paris Manual Therapy vs. Conventional Physiotherapy in Reducing Pain and Improving Function in Grade II Knee Osteoarthritis
A study testing Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept. and Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises. in people with Osteoarthritis (OA) of the Knee, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept. and Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept., Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.
- Keywords
- osteoarthritis, knee, Stanley Paris
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.Other
Also called Manual Therapy, Stanley Paris Approach, joint Mobilization and Movement Re-education
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 Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.Other
Also called Routine Physiotherapy, Standard Physical Therapy, Exercise and Electrotherapy Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from baseline to 4th week and 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start5 Aug 2025
- Primary completion25 Nov 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Helping Hand Institute of Rehabilitation Sciences
- Responsible party
- Principal investigator, Dr Abdul Haseeb Bhutta, Ibadat International University, Islamabad
- Investigators
- Prof. Dr. Muhammad Nazim Farooq, Ph.D., Study director, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317375
- Sponsor's protocol ID
- IIUI/RERC/ADT/2025/07/178-1
- Acronym
- SPMT vs CPT in
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that support the results of this study - including demographic data, baseline characteristics, intervention details, and outcome measures (VAS, KOOS, Range of Motion, and Berg Balance Scale scores) - may be shared. No personally identifiable information will be disclosed. Data will be available upon reasonable request from qualified researchers for academic or clinical research purposes following publication of the main study results.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stanley Paris Manual Therapy Concept Versus Conventional Physiotherapy in Pain Reduction and Functional Improvement in Grade II Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07317375
- Acronym / sponsor ID
- SPMT vs CPT in / IIUI/RERC/ADT/2025/07/178-1
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, knee, Stanley Paris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Collaborators
- Helping Hand Institute of Rehabilitation Sciences
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stanley Paris group | Experimental | Other: Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.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. |
| Conventional Physical Therapy | Active comparator | Other: Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept.Also: Manual Therapy, Stanley Paris Approach, joint Mobilization and Movement Re-educationThis 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 | Stanley Paris group |
| Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises.Also: Routine Physiotherapy, Standard Physical Therapy, Exercise and Electrotherapy ProgramThis 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 | Conventional Physical Therapy |
Primary outcome
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.
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that support the results of this study - including demographic data, baseline characteristics, intervention details, and outcome measures (VAS, KOOS, Range of Motion, and Berg Balance Scale scores) - may be shared. No personally identifiable information will be disclosed. Data will be available upon reasonable request from qualified researchers for academic or clinical research purposes following publication of the main study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Muhammad Nazim Farooq, Ph.D. study director
Ibadat International University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-on manual therapy including joint mobilization, soft tissue and neural mobilization, and movement retraining based on the Stanley Paris Concept. and Conventional Physiotherapy Standard physiotherapy care including electrotherapy modalities (TENS, ultrasound), strengthening, flexibility, and balance training exercises. in people with Osteoarthritis (OA) of the Knee, run by Ibadat International University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction Measured by Visual Analog Scale (VAS) (time frame: Change in pain intensity from baseline to 4th week and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.