Pain and function of patients with knee osteoarthritis were improved after receiving therapeutic exercise plus intraarticular medicine injection

The effect of intraarticular botulinum toxin type A, hyaluronate and saline injection plus therapeutic exercise on knee osteoarthritis: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13172678

Enrollment

Registered

2017-07-31

Start date

2016-01-10

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with knee osteoarthritis Musculoskeletal Diseases Knee osteoarthritis

Interventions

Participants are randomly allocated to receiving either an injection of BoNT-A (100U diluted with 2.5 ml saline), receiving hyaluronate (2.5 ml) or receiving saline (2.5 ml) (control) one time. All pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Mentally intact that were able to follow 2-step commands 2. Radiographic OA severity grade of 3 or above for the knee joint on the Kellgren-Lawrence scale 16 and pain visual analogue scale score=6 after Walking 100m continuously on level ground 3. Failure of physical therapy and/or medicine treatment in the last 3 months 4. Involvement of unilateral knee joint 5. Aged 18 and older

Exclusion criteria

Exclusion criteria: 1. Received an intraarticular (IA) injection into the affected knee within 3 months before the initial evaluation 2. Disease complications such as rheumatoid arthritis, tumors and any non-arthritic trauma to the affected knee in last 3 months 3. Severe cardiac, liver and kidney function deficiency

Design outcomes

Primary

Measure	Time frame
1. Pain stiffness and physical function is measured using the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire score (WOMAC) at baseline, week four and eight 2. Pain is measured using the Visual Analogue Scale (VAS) at baseline, week four and eight 3. Medical outcomes are assessed using the Medical outcomes study 36-item health survey (SF-36) at baseline, week four and eight	—

Measure

Time frame

1. Pain stiffness and physical function is measured using the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire score (WOMAC) at baseline, week four and eight 2. Pain is measured using the Visual Analogue Scale (VAS) at baseline, week four and eight 3. Medical outcomes are assessed using the Medical outcomes study 36-item health survey (SF-36) at baseline, week four and eight

—

Secondary

Measure	Time frame
Functional outcomes are measured using x-rays and MRI at baseline and week eight.	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026