Plain English Summary
Background and study aims
Knee OA is a chronic disease that is the most common joint disorder in China. Knee osteoarthritis (OA) occurs when the protective cartilage on the end of bones wears away. The bones in the knee then rub against one another, causing stiffness, pain and a reduction in the range of movement. It can affects the quality of life, and may even leads to depression. The usual treatment of knee OA usually includes medications, physical therapy and other alternative medical interventions. Although oral analgesics (painkillers taken by mouth), such as nonsteroidal anti-inflammatory drugs (NSAIDS), can achieve moderate reduction of pain and slight functional improvement, they have substantial limitations because they might not provide sufficient joint pain relief, often induce gastrointestinal discomfort, and can adversely interact with other drugs. Physical therapy and other alternative medical interventions are effective but their effects do not last long. There are surgical interventions with arthroscopic lavage and debridement for refractory joint pain (when the joint is washed out to remove any fluid and loose debris in the joint is removed) when medical therapies fail, but the benefits of these procedures are still being debated. As well, patients are not always willing to consider joint-replacement surgery when knee OA symptoms persist. Under such conditions, the potential treatment may switch to therapeutic exercise plus intra articular injection (an needle into the joint) of BoNT-A (a type of toxin that can help the pain) or hyaluronate (a type of sodium salt of hyaluronic acid). BoNT-A has shown to lead to significant improvement in pain and function and is safe to use in previous report. Hyaluronate injection is the current standard of care for knee OA. The aim of this study is to see if pain and dysfunction caused by knee OA could be alleviated by a combined effect of medicine and therapeutic exercise, without changes of knee joint structure.
Who can participate?
Adults aged 18 and older who have knee OA
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive an injection of BoNT-A. Those in the second group receive hyaluronate and those in the last group receive a saline injection. This is done once at the first visit. Participants are given an exercise to do for eight weeks. Participants are allowed up at the end of week four and eight to assess the treatment on their OA symptoms.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in the pain and function of the knee joint. There are no risks with participating.
Where is the study run from?
Yue Bei People’s Hospital (China)
When is the study starting and how long is it expected to run for?
January 2016 to December 2016
Who is funding the study?
Yue Bei People’s Hospital (China)
Who is the main contact?
Dr Xiao Bao
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2015CX/K025
Study information
Scientific title
The effect of intraarticular botulinum toxin type A, hyaluronate and saline injection plus therapeutic exercise on knee osteoarthritis: a randomized controlled trial
Acronym
Study hypothesis
Pain and dysfunction of knee OA could be alleviated by a combined effect of medicine and therapeutic exercise, without changes of knee joint structure.
Ethics approval
Yue Bei People’s Hospital, 30/06/2015, ref: 2015CX/K025
Study design
Single-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available.
Condition
Patients with knee osteoarthritis
Intervention
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 participants received the therapeutic exercise after injection for up to eight weeks.
All assessments were made at end of four and eight week to assess the outcomes of the treatment on the participants symptoms.
Intervention type
Drug
Phase
Drug names
Primary outcome measure
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 outcome measures
Functional outcomes are measured using x-rays and MRI at baseline and week eight.
Overall trial start date
01/01/2016
Overall trial end date
30/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
86
Participant 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
Recruitment start date
10/01/2016
Recruitment end date
30/08/2016
Locations
Countries of recruitment
China
Trial participating centre
Yue Bei People’s Hospital
No. 133 HuiMin Road
GuangDong
Shao Guan
512025
China
Funders
Funder type
Hospital/treatment centre
Funder name
Yue Bei People’s Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at Yue Bei People’s Hospital.
Intention to publish date
30/08/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list