Effects of Combined Physiotherapy Management and Education

NCT06347406 | Recruiting

• 1 other identifier: FSKesihatan
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:

• Are there any effects of combined physiotherapy program among individuals with PFPS on: i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be
• Measure for the anthropometrics data including body weight, height, and BMI.
• Answer the Numerical Pain Rating scale
• Abswe Malay version of KOOS-PF and TAMPA scale.
• Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive
• Blood flow restrictions cuff with physiotherapy exercises
• Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (6)

• Numerical Pain Rating

  On a Numerical Pain Rating Scale, often known as an NPRS, patients are asked to circle the number between 0 and 10, 0 and 20, or 0 and 100 that most properly portrays the intensity of pain that they are experiencing

  4 months

• The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)

  The KOOS-PF subscale is used to assess pain and function in the patellofemoral joint. The 11-point KOOS-PF, which was created in collaboration with healthcare professionals, demonstrated adequate measuring qualities and is recommended for clinical and research usage in patients suffering from patellofemoral pain

  4 months

• Tampa Scale

  The Tampa Kinesiophobia Scale (TSK) is a self-assessment measure used to determine a person's fear of movement-related pain who suffers from musculoskeletal discomfort

  4 months

• Hand held dynamometer (HDD)

  The examiner holds a small portable gadget against the patient's limb during a maximal isometric contraction. The equipment can test both the proximal and distal muscles of all extremitie

  4 months

• Knee Muscle performance Test with Dartfish software

  Dartfish data will be used to process the action of anteromedial lunge, step-down, bilateral squat, and balance and reach during simultaneous digital video acquisition. In other words, Dartfish programme will generate data. All of these movements will be measured with Dartfish software

  4 months

• Real time ultrasounds

  The thickness and length of the superficial quadriceps muscles (VMO, VL, VL, and RF).

  4 months

Study Arms (2)

Blood flow restriction combined with physiotherapy and education

EXPERIMENTAL

Blood flow restriction, combined with physiotherapy exercises and patient education

Other: Blood flow restriction combined with physiotherapy and education

Control Group

PLACEBO COMPARATOR

physiotherapy exercises

Other: Blood flow restriction combined with physiotherapy and education

Interventions

Blood flow restriction combined with physiotherapy and education OTHER

Blood flow restriction Physiotherapy exercises Education

Also known as: Linda Physiotherapy programme

Blood flow restriction combined with physiotherapy and education; Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pain and disability in at least three of the following activities involving pain around the patella
• Scored in KOOS-PF

You may not qualify if:

• Failure to regularly continue treatment sessions
• A history of knee surgery and severe trauma with meniscus or ligament tear within 6 months
• Went for acupuncture treatment
• Undergone any type of surgical procedure
• Pregnancy, cancer, secondary osteoarthritis and various rheumatologic diseases, and symptoms of abnormal neurological examination of sensation, movement, and reflexes

Sponsors & Collaborators

• Fakulti Sains Kesihatan: lead

Study Sites (1)

Fakulti Sains Kesihatan

Shah Alam, Selangor, 42300, Malaysia

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Physical Therapy Modalities; Educational Status

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Socioeconomic Factors; Population Characteristics

Central Study Contacts

Aslinda Maulat Mohd Fuhad

CONTACT

0169818007; lindalance87@gmail.com

Zarina Zahari

CONTACT

0132094170; zarinazahari@uitm.edu.my

Study Design

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

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)