Knee Osteoarthritis (Knee OA)NCT06875817
Effects of Feldenkrais Exercises in Knee Osteoarthritis Patients
A study testing Feldenkrais exercises and Standard physical therapy interventions in people with Knee Osteoarthritis (Knee OA), run by Riphah International University at 1 site in Pakistan.
Trial summary
The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Feldenkrais exercises and Standard physical therapy interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 40 to 60 years of patients.
- Both female and male
- Able to walk for 6 minutes (Timed up-and-go test)
- Able to rise from floor
- Grade 2 and 3 of osteoarthritis diagnosed with radiograph (Kellgren and Lawrence classification system)
- Pain reported on VAS score ˃6/10 in knee region for more than 3 months
Who cannot join
- • Tuberculosis, carcinoma, heart disease, and osteoporosis
- Any trauma or localized infection in the knee joint
- Hyper flexibility
- Open sores
- Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
- Psychiatric diseases such as phobia/obsession and depression
Show all 11Show fewer
- Allergy to hot pack
- Patients with a history of surgery in the knee region within a year.
- Severe cognitive impairments
- Contraindications to physical activity
- Concurrent participation in other physical therapy programs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
RIPHAH Rehabilitation Clinic, Punjab, Pakistan
Lahore, Punjab Province
Ghulam Fatima, PhD, 03034073057, ghulam.fatima@riphah.edu.pk
saliha Farooq, MS*
About this study
Official title: Effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients With Knee Osteoarthritis
The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Feldenkrais Method offers benefits comparable to back school lessons or core stability exercises. This study, conducted as a Randomized Controlled Trial at RIPHAH Rehabilitation Clinic, aims to assess the efficacy of Feldenkrais exercises compared to conventional physical therapy in addressing pain, range of motion, and disability in knee osteoarthritis patients aged 40-60 years. A non-probability convenience sampling method will recruit 32 participants meeting specific criteria for osteoarthritis severity and functional ability. Participants will be randomly assigned to Group A (Feldenkrais exercises) or Group B (conventional therapy), with interventions delivered over four weeks. Group A will engage in Feldenkrais exercises targeting pelvic and lower limb mobility, while Group B will receive standard treatments including knee isometrics, mobilization, transcutaneous electric nerve stimulation, and heating pad applications. Pain severity will be measured using the Numeric Pain Rating Scale, Range of Motion assessed via goniometry, and disability evaluated using the Western Ontario McMaster Universities Osteoarthritis Index. Statistical analysis using SPSS will compare outcomes between groups at baseline, post-treatment, and follow-up assessments.
Read the detailed description
Osteoarthritis (OA) is one of the most prevalent rheumatic diseases in the elderly, being a frequent cause of incapacity among this population. It is more common in the knee and is characterized by pain, stiffness, and function loss. OA is a major public health problem. The prevalence of knee OA is 34-45% in the Indian population with clinical symptoms of pain, reduced muscle strength, and knee function. That is the most common form of degenerative joint disease affecting 15 to 40% of people aged 40 and above. One hundred fifty-one million people worldwide experienced OA, and it was ranked sixth as a leading cause of moderate and severe disability. The knee is the joint most frequently affected by osteoarthritis. The Feldenkrais Method has the potential to help older people with OA. Developed by Dr. Moshe Feldenkrais, the method is a gentle form of exercise which has been shown to be acceptable for older people who have limited movement. The Feldenkrais Method is taught in two parallel forms, Awareness Through Movement (conducted as a group exercise) and Functional Integration (one-on one approach). This study explores the effectiveness of Awareness Through Movement lessons in helping older people with OA. The method aims for improved functioning, where the entire body cooperates efficiently with minimal effort. This study aims to explore the potential benefits of Feldenkrais exercises as an alternative, non-invasive treatment for knee osteoarthritis. Medical conventional treatments for knee OA, such as pharmacotherapy and surgical interventions, often come with limitations including potential side effects, high costs, and sometimes limited long-term effectiveness. These constraints necessitate the exploration of alternative, non-invasive treatment options that can be both effective and accessible. Feldenkrais exercises focus on improving movement patterns and body awareness, which may help reduce pain, enhance range of motion, and decrease disability.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Feldenkrais exercises, Standard physical therapy interventions
- Keywords
- Disability, Feldenkrais Method, Goniometry, Knee Osteoarthritis, Numeric Pain Rating Scale, Range of Motion
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais exercisesOther
Feldenkrais exercises focused on pain, improving mobility, and disability.
Standard physical therapy interventionsOther
- Knee Isometrics: Isometric exercises targeting the quadriceps and hamstrings, performed for 10 minutes, twice a week.
- Knee Mobilization
- Transcutaneous Electric Nerve Stimulation (TENS).
- Heating Pad Duration: 30-minute sessions, conducted twice a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group-A (Feldenkrais exercises) | Experimental | This group of participants will engage in Feldenkrais exercises focused on pain, improved mobility, and disability. Each session will last 30 minutes, conducted twice a week for 4 weeks. The exercises include Pelvic Clock Exercise, Knee Rolling, Ankle Circles, Knee Flexion and Extension and Leg Slides. Receives: Other: Feldenkrais exercises |
| Group-B (Standard Physicaltherapy interventions) | Active comparator | Participants will receive standard physical therapy interventions for knee osteoarthritis.
Protocol:
* Knee Isometrics: Isometric exercises targeting the quadriceps and hamstrings, performed for 10 minutes, twice a week.
* Knee Mobilization
* Transcutaneous Electric Nerve Stimulation (TENS).
* Heating Pad Duration: 30-minute sessions, conducted twice a week for 4 weeks. Receives: Other: Standard physical therapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.
Measured: upto 4 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
WOMAC is a disease-specific measure of health status (pain, stiffness, and function) in OA sufferers. It is widely used for evaluating hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
Measured: upto 4 weeks
Universal Goniometer (UG)
A universal goniometer is a crucial tool in orthopedics used to precisely measure joint angles. It exists in two primary forms: the short-arm version is ideal for smaller joints such as the wrist, elbow, or ankle, while the long-arm version is more accurate for joints with longer levers like the knee and hip. It highlighting its role in quantifying joint mobility and aiding in treatment planning and assessment in medical practice.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start2 Jan 2025
- Primary completion2 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghulam Fatima, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875817
- Sponsor's protocol ID
- REC/RCR & AHS/24/0150
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brooks PM. The burden of musculoskeletal disease--a global perspective. Clin Rheumatol. 2006 Nov;25(6):778-81. doi: 10.1007/s10067-006-0240-3. Epub 2006 Apr 12.
PubMed 16609823Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Vincent KR, Vincent HK. Resistance exercise for knee osteoarthritis. PM R. 2012 May;4(5 Suppl):S45-52. doi: 10.1016/j.pmrj.2012.01.019.
PubMed 22632702Salaffi F, Carotti M, Stancati A, Grassi W. Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res. 2005 Aug;17(4):255-63. doi: 10.1007/BF03324607.
PubMed 16285189Webb R, Cofre Lizama LE, Galea MP. Moving with ease: feldenkrais method classes for people with osteoarthritis. Evid Based Complement Alternat Med. 2013;2013:479142. doi: 10.1155/2013/479142. Epub 2013 Sep 3.
PubMed 24078825Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
PubMed 29035179
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06875817
- Acronym / sponsor ID
- REC/RCR & AHS/24/0150
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Disability, Feldenkrais Method, Goniometry, Knee Osteoarthritis, Numeric Pain Rating Scale, Range of Motion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 13 Mar 2025 (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.
The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Feldenkrais Method offers benefits comparable to back school lessons or core stability exercises. This study, conducted as a Randomized Controlled Trial at RIPHAH Rehabilitation Clinic, aims to assess the efficacy of Feldenkrais exercises compared to conventional physical therapy in addressing pain, range of motion, and disability in knee osteoarthritis patients aged 40-60 years. A non-probability convenience sampling method will recruit 32 participants meeting specific criteria for osteoarthritis severity and functional ability. Participants will be randomly assigned to Group A (Feldenkrais exercises) or Group B (conventional therapy), with interventions delivered over four weeks. Group A will engage in Feldenkrais exercises targeting pelvic and lower limb mobility, while Group B will receive standard treatments including knee isometrics, mobilization, transcutaneous electric nerve stimulation, and heating pad applications. Pain severity will be measured using the Numeric Pain Rating Scale, Range of Motion assessed via goniometry, and disability evaluated using the Western Ontario McMaster Universities Osteoarthritis Index. Statistical analysis using SPSS will compare outcomes between groups at baseline, post-treatment, and follow-up assessments.
Detailed description
Osteoarthritis (OA) is one of the most prevalent rheumatic diseases in the elderly, being a frequent cause of incapacity among this population. It is more common in the knee and is characterized by pain, stiffness, and function loss. OA is a major public health problem. The prevalence of knee OA is 34-45% in the Indian population with clinical symptoms of pain, reduced muscle strength, and knee function. That is the most common form of degenerative joint disease affecting 15 to 40% of people aged 40 and above. One hundred fifty-one million people worldwide experienced OA, and it was ranked sixth as a leading cause of moderate and severe disability. The knee is the joint most frequently affected by osteoarthritis. The Feldenkrais Method has the potential to help older people with OA. Developed by Dr. Moshe Feldenkrais, the method is a gentle form of exercise which has been shown to be acceptable for older people who have limited movement. The Feldenkrais Method is taught in two parallel forms, Awareness Through Movement (conducted as a group exercise) and Functional Integration (one-on one approach). This study explores the effectiveness of Awareness Through Movement lessons in helping older people with OA. The method aims for improved functioning, where the entire body cooperates efficiently with minimal effort. This study aims to explore the potential benefits of Feldenkrais exercises as an alternative, non-invasive treatment for knee osteoarthritis. Medical conventional treatments for knee OA, such as pharmacotherapy and surgical interventions, often come with limitations including potential side effects, high costs, and sometimes limited long-term effectiveness. These constraints necessitate the exploration of alternative, non-invasive treatment options that can be both effective and accessible. Feldenkrais exercises focus on improving movement patterns and body awareness, which may help reduce pain, enhance range of motion, and decrease disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A (Feldenkrais exercises) | Experimental | Other: Feldenkrais exercisesThis group of participants will engage in Feldenkrais exercises focused on pain, improved mobility, and disability. Each session will last 30 minutes, conducted twice a week for 4 weeks. The exercises include Pelvic Clock Exercise, Knee Rolling, Ankle Circles, Knee Flexion and Extension and Leg Slides. |
| Group-B (Standard Physicaltherapy interventions) | Active comparator | Other: Standard physical therapy interventionsParticipants will receive standard physical therapy interventions for knee osteoarthritis. Protocol: * Knee Isometrics: Isometric exercises targeting the quadriceps and hamstrings, performed for 10 minutes, twice a week. * Knee Mobilization * Transcutaneous Electric Nerve Stimulation (TENS). * Heating Pad Duration: 30-minute sessions, conducted twice a week for 4 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 40 to 60 years of patients.
- Both female and male
- Able to walk for 6 minutes (Timed up-and-go test)
- Able to rise from floor
- Grade 2 and 3 of osteoarthritis diagnosed with radiograph (Kellgren and Lawrence classification system)
Key exclusion criteria (11 listed)
- • Tuberculosis, carcinoma, heart disease, and osteoporosis
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 |
|---|---|---|
| Feldenkrais exercisesFeldenkrais exercises focused on pain, improving mobility, and disability. | Other | Group-A (Feldenkrais exercises) |
| Standard physical therapy interventions* Knee Isometrics: Isometric exercises targeting the quadriceps and hamstrings, performed for 10 minutes, twice a week. * Knee Mobilization * Transcutaneous Electric Nerve Stimulation (TENS). * Heating Pad Duration: 30-minute sessions, conducted twice a week for 4 weeks. | Other | Group-B (Standard Physicaltherapy interventions) |
Primary outcome
Numeric Pain Rating Scale
Time frame: upto 4 weeks
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: upto 4 weeks
WOMAC is a disease-specific measure of health status (pain, stiffness, and function) in OA sufferers. It is widely used for evaluating hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
Universal Goniometer (UG)
Time frame: upto 4 weeks
A universal goniometer is a crucial tool in orthopedics used to precisely measure joint angles. It exists in two primary forms: the short-arm version is ideal for smaller joints such as the wrist, elbow, or ankle, while the long-arm version is more accurate for joints with longer levers like the knee and hip. It highlighting its role in quantifying joint mobility and aiding in treatment planning and assessment in medical practice.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 16609823Brooks PM. The burden of musculoskeletal disease--a global perspective. Clin Rheumatol. 2006 Nov;25(6):778-81. doi: 10.1007/s10067-006-0240-3. Epub 2006 Apr 12.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- Background: PubMed 22632702Vincent KR, Vincent HK. Resistance exercise for knee osteoarthritis. PM R. 2012 May;4(5 Suppl):S45-52. doi: 10.1016/j.pmrj.2012.01.019.
- Background: PubMed 16285189Salaffi F, Carotti M, Stancati A, Grassi W. Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res. 2005 Aug;17(4):255-63. doi: 10.1007/BF03324607.
- Background: PubMed 24078825Webb R, Cofre Lizama LE, Galea MP. Moving with ease: feldenkrais method classes for people with osteoarthritis. Evid Based Complement Alternat Med. 2013;2013:479142. doi: 10.1155/2013/479142. Epub 2013 Sep 3.
- Background: PubMed 29035179Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- Individual participant dataSharing planned: No
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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.
Ghulam Fatima, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feldenkrais exercises and Standard physical therapy interventions in people with Knee Osteoarthritis (Knee OA), run by Riphah International University 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD* (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: upto 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875817, which also lists 6 linked publications.
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 13 Mar 2025.