NCT06875817

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

DisabilityFeldenkrais MethodGoniometryKnee OsteoarthritisNumeric Pain Rating ScaleRange of Motion

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    upto 4 weeks

Study Arms (2)

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.

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.

Other: Standard physical therapy interventions

Interventions

Feldenkrais exercises focused on pain, improving mobility, and disability.

Group-A (Feldenkrais exercises)

* 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.

Group-B (Standard Physicaltherapy interventions)

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RIPHAH Rehabilitation Clinic, Punjab, Pakistan

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 16609823BACKGROUND
  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PMID: 20699159BACKGROUND
  • Vincent 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.

    PMID: 22632702BACKGROUND
  • Salaffi 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.

    PMID: 16285189BACKGROUND
  • Webb 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.

    PMID: 24078825BACKGROUND
  • Lespasio 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.

    PMID: 29035179BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ghulam Fatima, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

Imran Amjad, PHD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 13, 2025

Study Start

January 2, 2025

Primary Completion

September 2, 2025

Study Completion

September 15, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations