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Clinical Trials/NCT07307118
NCT07307118
Completed
Not Applicable

Functional Hip Strength and Pain Changes in Women With Knee Osteoarthritis Following a Single-Dose Intra-Articular Platelet-Rich Plasma Injection and a 6-Week Home Exercise Program: A Single-Group Longitudinal Study

Firat University1 site in 1 country27 target enrollmentStarted: July 8, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Firat University
Enrollment
27
Locations
1
Primary Endpoint
Hip Stability Isometric Test (HipSIT) strength (N/kg), affected side

Overview

Brief Summary

This single-group longitudinal study evaluated changes in hip stability isometric strength, knee muscle strength, and activity-related pain in women with knee osteoarthritis following a single-dose intra-articular platelet-rich plasma (PRP) injection and a 6-week home exercise program. Outcomes were assessed at baseline (5 days post-injection), week 6, and week 12. The intervention included strengthening exercises for knee and hip muscle groups performed three times per week and regular walking encouragement with weekly phone follow-up for adherence.

Detailed Description

Participants with unilateral symptomatic knee osteoarthritis performed a standardized 6-week home strengthening program (knee extensors/flexors; hip extensors/abductors/external rotators) three times weekly and were encouraged to walk regularly. Hip Stability Isometric Test (HipSIT), quadriceps/hamstring strength (hand-held dynamometry, normalized to body mass), and activity pain (VAS 0-10) were measured at baseline, week 6, and week 12 to evaluate functional strength and symptom changes after PRP plus exercise.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female patients aged 45-70 years.
  • Radiographic knee osteoarthritis: Kellgren-Lawrence grade II-III in the affected knee and grade II or less in the unaffected knee.
  • Unilateral knee pain during activity with VAS score ≥5 (for at least the past 3 months).
  • Referred to physiotherapy following a unilateral single-dose PRP injection.

Exclusion Criteria

  • Any intra-articular knee injection within the past 6 months.
  • Regular lower-extremity strengthening exercise or non-pharmacological treatment for knee OA within the past 6 weeks.
  • History of lower-extremity surgery.
  • History of neurological, rheumatological and/or cognitive diseases.
  • Unable to use a telephone.

Arms & Interventions

Single Group: PRP Injection + Home Exercise Program

Experimental

All participants received a unilateral single-dose intra-articular platelet-rich plasma (PRP) injection for symptomatic knee osteoarthritis, followed by a 6-week home-based strengthening and functional exercise program performed 3 times per week. The exercise program targeted knee extensors/flexors and hip extensors/abductors/external rotators. Participants were encouraged to walk at least 30 minutes on at least 5 days per week and were contacted weekly by phone to support adherence.

Intervention: Platelet-Rich Plasma (PRP) Injection (Biological)

Single Group: PRP Injection + Home Exercise Program

Experimental

All participants received a unilateral single-dose intra-articular platelet-rich plasma (PRP) injection for symptomatic knee osteoarthritis, followed by a 6-week home-based strengthening and functional exercise program performed 3 times per week. The exercise program targeted knee extensors/flexors and hip extensors/abductors/external rotators. Participants were encouraged to walk at least 30 minutes on at least 5 days per week and were contacted weekly by phone to support adherence.

Intervention: Home Exercise Program (Behavioral)

Outcomes

Primary Outcomes

Hip Stability Isometric Test (HipSIT) strength (N/kg), affected side

Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12

Hip stability isometric strength (combined hip extensor, abductor and external rotator maximum isometric strength) assessed using a hand-held dynamometer during the Hip Stability Isometric Test (HipSIT). The test is performed in side-lying "clam" position (hip 45° flexion, knee 90° flexion). Three maximal trials (5 seconds each) are performed and the maximum force output (N) is normalized to body mass (N/kg).

Secondary Outcomes

  • Quadriceps femoris isometric strength (N/kg), affected side(Baseline (5 days post PRP injection), Week 6, Week 12)
  • Hamstring isometric strength (N/kg), affected side(Baseline (5 days post PRP injection), Week 6, Week 12)
  • Knee pain during activity (Visual Analog Scale, 0-10)(Baseline (5 days post PRP injection), Week 6, Week 12)

Investigators

Sponsor
Firat University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muharrem Gökhan Beydağı

Assistant Professor

Firat University

Study Sites (1)

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