Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001046493
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
22/09/2025
Date last updated
22/09/2025
Date data sharing statement initially provided
22/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Secondary Knee Osteoarthritis - Pain Assessment and Functional Evolution after Rehabilitation
Scientific title
Assessment of Pain and Functional Evolution after 3-month in-home Rehabilitation in Former Football Players Diagnosed with Secondary Knee Osteoarthritis
Secondary ID [1] 314697 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 337881 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334212 334212 0 0
Physiotherapy
Musculoskeletal 334364 334364 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The strategies used to monitor adherence to the intervention the session attendance, the VAS scale for pain, the Lequesne index, and the WOMAC scale for functionality – initial, when all patients were included in study and final, after 3 months.
We`ll performed the following interventions for all patients:
1. Ultrasound Exam of the Knee (initial and after 3 months)
• Supervisor/Provider: The exam is conducted by a qualified sonographer.
• Mode of Administration: The examination is carried out on a one-on-one basis in a private setting where only the patient and the sonographer are present.
• CARTILAGE THICKNESS – is a study parameter
2. Pressure Pain Assessment with Algometer (bilaterally at the knee using an Algometer II - SBMedic Electronics, Sweden; the probe - 1 cm² will be applied perpendicularly with pressure increasing at ~1 N/s until pain was reported).
• Supervisor/Provider: This procedure is supervised and administered by a physiotherapist specialized in pain assessment and treatment.
• Mode of Administration: The procedure is performed individually, with the physiotherapist applying pressure directly to the affected knee area to assess the patient's pain level. For areas will be investigated (superior, inferior, medial and lateral knee area)
3. Imagistic X-ray of the Knee:
• Supervisor/Provider: The X-ray is performed by a radiologic technician.
• Mode of Administration: The procedure is conducted individually in an X-ray room, where the patient is positioned appropriately to obtain the clearest possible images of the knee structure.
• KELLGREN-LAWRENCE GRADE will be used to assess the knee osteoarthritis grade
4. Physical procedures (TENS, laser, ultrasound) administered by a physiotherapist in a clinical setting.
• Transcutaneous Electrical Nerve Stimulation (TENS) of the quadriceps muscles and calf muscles (Endomed 482, device series 42.400, Enraf-Nonius, Netherlands); 30 min daily session of TENS for 6 days each week using two pairs of 10 cm × 15 cm carbon rubber electrodes (150 cm2), one for each side, stimulated both muscle groups, 15 minutes each region.
• Low-Level Laser Therapy (LLLT) 20 minutes, daily (ASTAR PhysioGo 500I/501I Poland, PhysioGo series) Wavelength of 808 nm, a power of 100 mW, and an energy dosage of 7 J / cm2 , energy per point of 0.003 J. Applied for knee girdle muscles, left and right.
• Ultrasound (BTL 4000). The treatment is carried out on an individual basis, where the patient is comfortably seated, and the ultrasound head (0.6 W/cm2) is moved in a circular motion over the affected knee area, for 10 minutes, left and right.
5. In-patient kinetic program (stretching, strength, aerobic training) administered by a physiotherapist in a clinical setting.
- stretching of adductor and hamstrings muscles, daily, 10 minutes
- strength exercises (gluteus medium and quadriceps), daily, 15 minutes
- aerobic training (endurance training) performed at 60%–80% of maximum heart rate, according to the equation ((220 – age) × 0.65), three times a week, 40 minutes
In-patient kinetic program occurs daily for the duration of hospital stay, as it was mentioned bellow.
6. Out-patient 3 months home-training; occurs 3 days after hospital discharge
Aerobic training, three times a week, 40 minutes
- Warm-up (10 minutes): gentle stretching and slow walking or stationary cycling
- Main Activity (20 minutes): walking on flat surface or treadmill
- Cool-down (10 minutes): slow walking and stretching
Flexibility training, three times a week, 40 minutes
- Warm-up (10 minutes): light cardiovascular exercise like walking or stationary cycling at a very low intensity.
- Main Activity (20 minutes): Dynamic stretches: leg swings and arm circles to improve range of motion. Static stretches: hold stretches for each major muscle group for 20-30 seconds, such as hamstring and quadriceps stretches, and arm stretches.
- Cool-down (10 minutes): Deep breathing and relaxation techniques to enhance muscle relaxation.
Intervention code [1] 331303 0
Diagnosis / Prognosis
Intervention code [2] 331304 0
Rehabilitation
Intervention code [3] 331414 0
Treatment: Other
Comparator / control treatment
Patients from the control group will have not the recommendation for 3 months home-training.
The rehabilitation program for control group will include the same physical therapy measures and in-patient kinetic program.
1. Ultrasound Exam of the Knee (initial and after 3 months)
• Supervisor/Provider: The exam is conducted by a qualified sonographer.
• Mode of Administration: The examination is carried out on a one-on-one basis in a private setting where only the patient and the sonographer are present.
• CARTILAGE THICKNESS – is a study parameter
2. Pressure Pain Assessment with Algometer (bilaterally at the knee using an Algometer II - SBMedic Electronics, Sweden; the probe - 1 cm² will be applied perpendicularly with pressure increasing at ~1 N/s until pain was reported).
• Supervisor/Provider: This procedure is supervised and administered by a physiotherapist specialized in pain assessment and treatment.
• Mode of Administration: The procedure is performed individually, with the physiotherapist applying pressure directly to the affected knee area to assess the patient's pain level. For areas will be investigated (superior, inferior, medial and lateral knee area)
3. Imagistic X-ray of the Knee:
• Supervisor/Provider: The X-ray is performed by a radiologic technician.
• Mode of Administration: The procedure is conducted individually in an X-ray room, where the patient is positioned appropriately to obtain the clearest possible images of the knee structure.
• KELLGREN-LAWRENCE GRADE will be used to assess the knee osteoarthritis grade
4. Physical procedures (TENS, laser, ultrasound) administered by a physiotherapist in a clinical setting.
• Transcutaneous Electrical Nerve Stimulation (TENS) of the quadriceps muscles and calf muscles (Endomed 482, device series 42.400, Enraf-Nonius, Netherlands); 30 min daily session of TENS for 6 days each week using two pairs of 10 cm × 15 cm carbon rubber electrodes (150 cm2), one for each side, stimulated both muscle groups, 15 minutes each region.
• Low-Level Laser Therapy (LLLT) 20 minutes, daily (ASTAR PhysioGo 500I/501I Poland, PhysioGo series) Wavelength of 808 nm, a power of 100 mW, and an energy dosage of 7 J / cm2 , energy per point of 0.003 J. Applied for knee girdle muscles, left and right.
• Ultrasound (BTL 4000). The treatment is carried out on an individual basis, where the patient is comfortably seated, and the ultrasound head (0.6 W/cm2) is moved in a circular motion over the affected knee area, for 10 minutes, left and right.
5. In-patient kinetic program (stretching, strength, aerobic training) administered by a physiotherapist in a clinical setting.
- stretching of adductor and hamstrings muscles, daily, 10 minutes
- strength exercises (gluteus medium and quadriceps), daily, 15 minutes
- aerobic training (endurance training) performed at 60%–80% of maximum heart rate, according to the equation ((220 – age) × 0.65), three times a week, 40 minutes
Control group
Active

Outcomes
Primary outcome [1] 341873 0
Pain
Timepoint [1] 341873 0
Baseline and 12 weeks post commencement of intervention
Primary outcome [2] 341874 0
Function of lower limb
Timepoint [2] 341874 0
Baseline and 12 weeks post commencement of intervention
Secondary outcome [1] 448851 0
Quality of life
Timepoint [1] 448851 0
Baseline and 12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
1. Clinical and radiological diagnosis of secondary knee osteoarthritis
2. Former football players (with a minimum of 5 years of active participation in amateur or professional football)
3. Symptoms present for at least 3 months (e.g., pain, stiffness, reduced mobility)
4. Lequesne Index score = greater than or equal to 7 (mild to moderate functional impairment)
5. VAS pain score during walking = greater than or equal to 4
6. Measurable Pressure Pain Threshold (PPT) using a pressure algometer
7. Able to walk without permanent walking aids
8. BMI between 18.5 and 40
9. No intra-articular injections (corticosteroids, hyaluronic acid) within the last 3 months
10. No knee surgeries within the last 6 months
11. Ability to understand and sign the informed consent form
Minimum age
45 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of total or partial knee arthroplasty
2. Presence of other significant musculoskeletal or neurological disorders affecting gait or joint function (e.g., rheumatoid arthritis, peripheral neuropathy)
3. Current opioid therapy or chronic use of strong analgesics
4. Severe obesity (BMI > 40)
5. Cognitive impairment or psychiatric disorders interfering with the ability to complete clinical assessments or follow the rehabilitation program
6. Recent trauma to the lower limbs (within the last 3 months)
7. Participation in another clinical trial within the last 30 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2025
Date of last participant enrolment
Anticipated
22/09/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
43
Accrual to date
43
Final
Recruitment outside Australia
Country [1] 27126 0
Romania
State/province [1] 27126 0
Craiova

Funding & Sponsors
Funding source category [1] 319247 0
Hospital
Name [1] 319247 0
Filantropia Hospital Craiova
Country [1] 319247 0
Romania
Primary sponsor type
Hospital
Name
Filantropia Hospital Craiova
Address
Country
Romania
Secondary sponsor category [1] 321719 0
University
Name [1] 321719 0
University of Medicine and Pharmacy Craiova
Address [1] 321719 0
Country [1] 321719 0
Romania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317826 0
Ethic Committee for Scientific Research of Filantropia Hospital Craiova
Ethics committee address [1] 317826 0
Ethics committee country [1] 317826 0
Romania
Date submitted for ethics approval [1] 317826 0
30/01/2025
Approval date [1] 317826 0
28/02/2025
Ethics approval number [1] 317826 0
4665 / 28february 2025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142278 0
A/Prof Kamal Constantin
Address 142278 0
Petru Rares, nr. 2. Cod 200349. CRAIOVA - Dolj ROMÂNIA
Country 142278 0
Romania
Phone 142278 0
+40748117735
Fax 142278 0
Email 142278 0
[email protected]
Contact person for public queries
Name 142279 0
Kamal Constantin
Address 142279 0
Petru Rares, nr. 2. Cod 200349. CRAIOVA - Dolj ROMÂNIA
Country 142279 0
Romania
Phone 142279 0
+40748117735
Fax 142279 0
Email 142279 0
[email protected]
Contact person for scientific queries
Name 142280 0
Kamal Constantin
Address 142280 0
Petru Rares, nr. 2. Cod 200349. CRAIOVA - Dolj ROMÂNIA
Country 142280 0
Romania
Phone 142280 0
+40748117735
Fax 142280 0
Email 142280 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.