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Knee OsteoarthritisNCT05033977

Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection

A study testing Exercise (center-based) and Exercise (home-based) in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. Read more about this study

Who is it for?
Ages 45 to 70 years, women only
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Exercise (center-based) and Exercise (home-based)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2018to 1 Apr 2020
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 45 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with knee osteoarthritis
  • Patients with PRP injections

Who cannot join

  • have any neurologic disease
  • have any oncologic disease
  • have any other intraarticular injection last 6 months

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, Samanpazari, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigating of Difference Between Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection in Women With Knee Osteoarthritis

Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. The purpose of this study was to compare the effectiveness of supervised physiotherapy and home exercises after PRP injection in patients with knee OA. The investigator hypothesized that the supervised physiotherapy program would be more effective in decreasing pain and improving muscle strength, physical function, and quality of life than home exercises following PRP injection in patients with knee OA. A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.

Read the detailed description

A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.

Pain Measurement Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity.

Muscle Strength Measurement Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement. According to this technique, the evaluator gradually overcomes the muscle strength and stops when the joint gives way. The quadriceps muscle strength was measured in a sitting position (Hip 90° flexion, knee extended) with hands crossed across the chest. The hand-held dynamometer was positioned on the anterior surface of the lower leg proximal to the ankle during test. Hamstring muscle group measurement was carried out on prone position (Hip neutral position, knee flexion 90°). The hand-held dynamometer was positioned on the posterior surface of the lower leg proximal to the ankle during test. The HipSIT evaluates the abductor, external rotator and extensor muscles of the hip together. This test was performed in a side-lying position (Hips 45° flexion, knees 90° flexion, heels in contact with the limb tested superior to opposing limb as 20° abduction). The hand-held dynamometer was placed on laterally positioned 5 cm above the knee joint interline during test. Each measurement for each muscle was performed 3 times at 30 sec intervals and the higher value was recorded. There was also a minute interval between muscle groups measurements.

Functional Status The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-administered test for OA to assess functions of the affected joints. It consists of 24 questions (three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions).

Interventions Each subject was informed about knee OA and daily activities that negatively affect the knee OA. They were also asked to use cold press 3 times (10-15 min) a day for 6 weeks. Supervised physiotherapy group performed exercises 3 times a week for 6 weeks under supervision of a physiotherapist after the first evaluation. The subjects in home exercise group were taught exercises and they were informed to do exercises 3 times a week for 6 weeks. Home exercise group was telephoned to motivate them to do exercise or to find out if they have any problem about the exercises once a week for 6 weeks. The exercise programs for each group consisted of these parts: warm up, strengthening, balance and cool down period. The standard exercises were performed by all of the subjects in each group in order to standardize the exercise procedure. We used OMNI Resistance Exercise Scale for perceived effort to standardize elastic-band (Thera-Band; The Hygenic Corporation, Akron, OH) resistance among subjects. Subjects were asked to do 3 repetitions for each exercise starting with lowest resistance elastic band, and the resistance of the elastic band was increased until it reached 5 on the 11-point scale to determine the appropriate elastic band. Second measurements were performed at the end of 6 weeks, the day of routine doctor control for PRP injection. All assessments were performed by the same physiotherapist.

Being tested
Exercise (center-based), Exercise (home-based)
Keywords
Knee, Osteoarthritis, Exercise, Platelet rich plasma, muscle strength
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise (center-based)Other

    Exercise therapy with a physical therapist in a clinic.

  • Exercise (home-based)Other

    Patients did exercises at home every day and 3 times per day.

Study groups in NCT05033977
Study groupRoleWhat they receive
Center-based ExerciseExperimentalpatients did exercises with a physical therapist in a clinic 3 days and 45 minute in a week for 6 weeks. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings.
Receives: Other: Exercise (center-based)
Home-based exerciseExperimentalPatients did exercises at home every day and 3 times per day. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings.
Receives: Other: Exercise (home-based)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visuel analogue scale

    Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity

    Measured: 6 weeks

  2. Muscle Strenght

    Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement.

    Measured: 6 weeks

Secondary outcomes (5)
  1. Physical Function

    A 30-sec chair stand test and stair climb test were used to assess physical performance. The subjects were asked to stand up from a chair (height: 43cm) and sit down in 30 sec with their arms folded across the chest during the 30-sec chair stand test. The number of the repetitions were recorded. The subjects were asked to ascend and descend 10 steps (step height 20 cm) at a safe and comfortable pace during the stair climb test. The time (sec) of stair ascend and descend were recorded separately.

    Measured: 6 weeks

  2. Knee Function

    The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-administered test for OA to assess functions of the affected joints. It consists of 24 questions (three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions)

    Measured: 6 weeks

  3. Weight

    participants' weight was measured with a digital scale

    Measured: 6 weeks

  4. Height

    participants' height was measured with a tape measure

    Measured: 6 weeks

  5. Body mass index (BMI)

    Body Mass Index was calculated using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start1 Jul 2018
  3. Primary completion1 Jul 2019
  4. Study completion1 Apr 2020

Resources

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
supervised exercise group home exercise group
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033977
Sponsor's protocol ID
GO 2021/049
Status last verified
Aug 2021
First submitted
31 May 2021
Last updated
5 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise (center-based) and Exercise (home-based) in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).

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 2 inclusion and 3 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 5 Sep 2021. 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 Turkey (Türkiye). 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?

Visuel analogue scale (time frame: 6 weeks). The study lists 2 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 5 Sep 2021.

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