Osteoarthritis, KneePhase 4NCT02320500
Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
A Phase 4 study testing Standard Physiotherapy and Myofascial-specific therapy in people with Osteoarthritis, Knee, run by Queen's University at 1 site in Canada.
Trial summary
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Standard Physiotherapy and Myofascial-specific therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Dec 2016
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bi or unilateral knee OA
- knee pain attributed to knee OA
- referral to orthopedics as a potential candidate for knee total knee arthroplasty
- ability to comprehend/sign consent, independent mobility without assistive devices
Who cannot join
- allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
- infections of clinical abnormalities other than knee OA that could cause the knee pain
- other diagnosed chronic pain syndrome for which they are taking regular pain medications
- pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the investigators expect those who receive myofascial-specific therapy to experience reduced pain (compared to the standard therapy group) and increased flexibility compared to baseline levels. This simple conservative therapy could postpone (or in some cases, eliminate) the need for a knee replacement since pain is the major indication for surgery. If successful, this treatment could improve the quality of life and increase productivity for thousands suffering from knee osteoarthritis and preserve valuable health care resources.
Read the detailed description
Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks.
The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.
The Secondary outcomes will include:
(Comparisons between and/or within groups where appropriate):
- Pain score biweekly up to 8 weeks, at 3 months and 6 months
- Decision to proceed with surgery (yes/no)-to assess the alteration in the need for TKA
- Decision to continue treatment-(yes/no) is treatment beneficial?
- Function -Biodex, 6 min.walk test, Timed up and go- Measured at baseline and 3 months following last therapy session for standard vs. myofascial -is myofascial therapy better for function?
- Brief Pain Interference (BPI) short form- Baseline, 2 weeks and 8 weeks- to assess pain interference
- Oxford knee scores-Baseline, 2 and 8 weeks- reported functional disability (compare groups and to objective measures)
- McGill SF pain questionnaire at Baseline, 2 weeks and 8 weeks-to assess pain quality
- SF-12 at Baseline, 2 weeks and 8 weeks-to assess quality of life
- Analgesics consumed at Baseline, 2 weeks, 8 weeks, 6 months-to assess pain levels
- Compare the X-ray osteoarthritis (OA) grade with initial assessment of MTPs-Does presence of myofascial trigger points (MTPs) explain discordance between OA grade and pain?
- Pain scores on a 10 cm visual analogue scale at Baseline, 2 weeks, 6 months- assess change in pain intensity
- Surgery by 6 month follow-up? Yes/No, If so, when? - postponed or eliminated need for TKA?
- Conditions
- Osteoarthritis, Knee
- Being tested
- Standard Physiotherapy, Myofascial-specific therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PhysiotherapyBehavioural
standard of care physiotherapy once every 2 weeks for 8 weeks
Myofascial-specific therapyOther
Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
| Study group | Role | What they receive |
|---|---|---|
| standard physiotherapy | Active comparator | Standard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA) Receives: Behavioral: Standard Physiotherapy |
| Myofascial-specific therapy | Experimental | Patient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks) Receives: Other: Myofascial-specific therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on visual analogue scale (VAS)
Measured: 8 weeks
Secondary outcomes (8)
Brief pain inventory (BPI)
Measured: biweekly for 8 weeks, 3 months, 6 months
Oxford knee score
Measured: biweekly for 8 weeks, 3 months, 6 months
McGill short pain questionnaire
Measured: biweekly for 8 weeks, 3 months, 6 months
timed up and go (TUG)
Measured: Baseline, 3 months
6 minute walk test
Measured: Baseline, 3 months
Biodex functional tests
Measured: Baseline, 3 months
total knee arthroplasty? If so, when
Measured: 6 month
VAS pain scores
Measured: biweekly up to 8 weeks, then 3 months & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gavin Wood, Queen's University
- Investigators
- Richard Henry, MD, FRCPC, Principal investigator, Queens University/Kingston General HospitalGavin Wood, MD, FRCSC, Principal investigator, Queens University/Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320500
- Sponsor's protocol ID
- ANAE-217-12
- Other IDs
- NOL 158909
- Status last verified
- Apr 2018
- First submitted
- 2 Dec 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02320500
- Acronym / sponsor ID
- ANAE-217-12
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the investigators expect those who receive myofascial-specific therapy to experience reduced pain (compared to the standard therapy group) and increased flexibility compared to baseline levels. This simple conservative therapy could postpone (or in some cases, eliminate) the need for a knee replacement since pain is the major indication for surgery. If successful, this treatment could improve the quality of life and increase productivity for thousands suffering from knee osteoarthritis and preserve valuable health care resources.
Detailed description
Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks.
The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.
The Secondary outcomes will include:
(Comparisons between and/or within groups where appropriate):
- Pain score biweekly up to 8 weeks, at 3 months and 6 months
- Decision to proceed with surgery (yes/no)-to assess the alteration in the need for TKA
- Decision to continue treatment-(yes/no) is treatment beneficial?
- Function -Biodex, 6 min.walk test, Timed up and go- Measured at baseline and 3 months following last therapy session for standard vs. myofascial -is myofascial therapy better for function?
- Brief Pain Interference (BPI) short form- Baseline, 2 weeks and 8 weeks- to assess pain interference
- Oxford knee scores-Baseline, 2 and 8 weeks- reported functional disability (compare groups and to objective measures)
- McGill SF pain questionnaire at Baseline, 2 weeks and 8 weeks-to assess pain quality
- SF-12 at Baseline, 2 weeks and 8 weeks-to assess quality of life
- Analgesics consumed at Baseline, 2 weeks, 8 weeks, 6 months-to assess pain levels
- Compare the X-ray osteoarthritis (OA) grade with initial assessment of MTPs-Does presence of myofascial trigger points (MTPs) explain discordance between OA grade and pain?
- Pain scores on a 10 cm visual analogue scale at Baseline, 2 weeks, 6 months- assess change in pain intensity
- Surgery by 6 month follow-up? Yes/No, If so, when? - postponed or eliminated need for TKA?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard physiotherapy | Active comparator | Behavioral: Standard PhysiotherapyStandard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA) |
| Myofascial-specific therapy | Experimental | Other: Myofascial-specific therapyPatient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of bi or unilateral knee OA
- knee pain attributed to knee OA
- referral to orthopedics as a potential candidate for knee total knee arthroplasty
- ability to comprehend/sign consent, independent mobility without assistive devices
Key exclusion criteria (4 listed)
- allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
- infections of clinical abnormalities other than knee OA that could cause the knee pain
- other diagnosed chronic pain syndrome for which they are taking regular pain medications
- pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physiotherapystandard of care physiotherapy once every 2 weeks for 8 weeks | Behavioural | standard physiotherapy |
| Myofascial-specific therapyOnce every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician) | Other | Myofascial-specific therapy |
Primary outcome
Pain scores on visual analogue scale (VAS)
Time frame: 8 weeks
8 secondary outcomes
Brief pain inventory (BPI)
Time frame: biweekly for 8 weeks, 3 months, 6 months
Oxford knee score
Time frame: biweekly for 8 weeks, 3 months, 6 months
McGill short pain questionnaire
Time frame: biweekly for 8 weeks, 3 months, 6 months
timed up and go (TUG)
Time frame: Baseline, 3 months
6 minute walk test
Time frame: Baseline, 3 months
Biodex functional tests
Time frame: Baseline, 3 months
total knee arthroplasty? If so, when
Time frame: 6 month
VAS pain scores
Time frame: biweekly up to 8 weeks, then 3 months & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Henry, MD, FRCPC principal investigator
Queens University/Kingston General Hospital
Gavin Wood, MD, FRCSC principal investigator
Queens University/Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Physiotherapy and Myofascial-specific therapy in people with Osteoarthritis, Knee, run by Queen's University at 1 site in Canada.
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 4 inclusion and 4 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 6 Apr 2018. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain scores on visual analogue scale (VAS) (time frame: 8 weeks). 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 6 Apr 2018.