Osteo Arthritis KneeNCT02454374
Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1)
A study testing Knee Loading protocol and Routine Physiotherapy Care in people with Osteo Arthritis Knee, run by Leeds Comunity Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This study is a randomised controlled clinical trial designed to evaluate the effectiveness of two different exercise based treatments in the management of patients with knee problems related to degenerative (wear and tear) changes. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Knee Loading protocol and Routine Physiotherapy Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to the Leeds Community Healthcare Musculoskeletal service aged 45 years or over with primary symptoms suggestive of degenerative intraarticular knee pain with a dominant mechanical presentation (i.e. activity related pain, functional limitation, morning stiffness not exceeding 30 minutes) AND
- Limitation in weightbearing range of motion of the knee joint (tibiofemoral joint limitation in flexion or extension)
Who cannot join
- Subjects with cognitive impairment or medical conditions preventing understanding or participation in the study
- Subjects with symptoms requiring surgical evaluation or other intervention
- Knee symptoms related to pathology other than degenerative intraarticular pathology
- Subjects who are contraindicated from kneeling or crouching
- Subjects unable to attend the full study programme
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Musculosktal Servive
Leeds
Steven Foster, 0113 8430247, steven.foster@nhs.net
About this study
This study is a randomised controlled clinical trial designed to evaluate the effectiveness of two different exercise based treatments in the management of patients with knee problems related to degenerative (wear and tear) changes.
Recent evidence suggests that putting weight through a joint (joint loading) may be beneficial.
Read more
The Investigators know that physiotherapy and exercise is important in treating these patients, but the investigators do not know which exercises work best. In this study the investigators will be comparing current physiotherapy care against a new programme of exercises that gradually increases the amount of joint loading.
The study will recruit approximately 140 patients from the Leeds Musculoskeletal (MSK) service, who are over the age of 45 and have been referred for physiotherapy by their GP for activity related knee pain.Patients who are suitable and happy to take part will be selected randomly (not chosen by the patient or physiotherapist) to receive either normal physiotherapy treatment, or the knee loading exercises. The treatment phase will last for six weeks and participants will be asked to carry out their exercises twice daily during this time. At the end of this period, patients will be asked tocomplete questionnaires and again at six months so that the investigators can assess how the patients are doing.
The main aim is to evaluate clinical effectiveness of the progressive joint loading protocol. However, the data collected will also be used to see if there is a way of identifying in advance those who might respond better to either treatment.
The investigators will also collect some information relating to the cost effectiveness of delivering different treatments. The final aim of this study is to test how easy it is to collect more detailed data in this area if a related study were to be carried out in the future.
Read the detailed description
The Leeds University academic partner will provide statistical support for the study team during the data analysis phase. Predictor variables with a substantial single variable association with each outcome (p<0.2) will be included in a multivariable linear regression model to determine the adjusted associations of improved outcome from being in the treatment arm. A second model will use multi-levels (two levels: 1. time points for individuals, 2. individuals) to determine whether the trajectory of change in outcome scores differs between the two arms of the study. Significant predictors of improved outcomes will be determined from both of these models. A sensitivity analysis will be undertaken for final models based on degrees of compliance to home treatment using categories determined through exploratory analysis of the data.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Knee Loading protocol, Routine Physiotherapy Care
- Keywords
- Physiotherapy, Knee Loading, Randomised Controlled Trial, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Loading protocolProcedure or surgery
The clinician will review the patient at follow up appointments a further two to four times during the treatment period (dependent on symptom resolution/response), progressing to the next level of exercises or by increasing intensity, duration or repetitions as appropriate (each participant will be asked to maintain a home treatment diary sheet). The physiotherapist will encourage compliance during the treatment period and beyond.
Routine Physiotherapy CareProcedure or surgery
Routine Physiotherapy Care
| Study group | Role | What they receive |
|---|---|---|
| Knee Loading | Experimental | Progressive joint loading intervention will be taught by a program of exercises by the treating physiotherapist. The intervention consists of knee flexion (bending) and knee extension (straightening). Participants will be assessed for their immediate response to treatment during each assessment or treatment session and advised on the appropriate level of self-directed exercises to be performed twice daily. The clinician will review the patient at follow up appointments during the treatment period, progressing to the next level of exercises or by increasing intensity, duration or repetitions as appropriate. The physiotherapist will encourage compliance during the treatment period and beyond Receives: Procedure: Knee Loading protocol |
| Routine physiotherapy care | Active comparator | Normal care delivered to the control group will be based on current NICE guidelines (2014) for non-pharmacological management of OA which includes verbal and written advice/education; education regarding weight loss; exercise to include local muscle strengthening and general aerobic fitness; with or without manual therapy. Clinicians will be asked to refrain from using the progression of techniques specifically documented in the progressive loading protocol (not currently considered to constitute 'normal care'). Treating clinicians will be asked to record specific exercises and manual therapy techniques employed in the patient's records. Participants will be asked to complete a home treatment record sheet. Receives: Procedure: Routine Physiotherapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome score (KOOS)
Measured: 6 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Comunity Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Foster, Principal investigator, Leeds Community Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454374
- Sponsor's protocol ID
- NP0159
- Status last verified
- May 2015
- First submitted
- 15 Apr 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1)
- ClinicalTrials.gov ID
- NCT02454374
- Acronym / sponsor ID
- NP0159
- Conditions
- Osteo Arthritis Knee
- Keywords
- Physiotherapy, Knee Loading, Randomised Controlled Trial, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Leeds Comunity Healthcare NHS TrustUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 27 May 2015 (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.
This study is a randomised controlled clinical trial designed to evaluate the effectiveness of two different exercise based treatments in the management of patients with knee problems related to degenerative (wear and tear) changes.
Recent evidence suggests that putting weight through a joint (joint loading) may be beneficial.
The Investigators know that physiotherapy and exercise is important in treating these patients, but the investigators do not know which exercises work best. In this study the investigators will be comparing current physiotherapy care against a new programme of exercises that gradually increases the amount of joint loading.
The study will recruit approximately 140 patients from the Leeds Musculoskeletal (MSK) service, who are over the age of 45 and have been referred for physiotherapy by their GP for activity related knee pain.Patients who are suitable and happy to take part will be selected randomly (not chosen by the patient or physiotherapist) to receive either normal physiotherapy treatment, or the knee loading exercises. The treatment phase will last for six weeks and participants will be asked to carry out their exercises twice daily during this time. At the end of this period, patients will be asked tocomplete questionnaires and again at six months so that the investigators can assess how the patients are doing.
The main aim is to evaluate clinical effectiveness of the progressive joint loading protocol. However, the data collected will also be used to see if there is a way of identifying in advance those who might respond better to either treatment.
The investigators will also collect some information relating to the cost effectiveness of delivering different treatments. The final aim of this study is to test how easy it is to collect more detailed data in this area if a related study were to be carried out in the future.
Detailed description
The Leeds University academic partner will provide statistical support for the study team during the data analysis phase. Predictor variables with a substantial single variable association with each outcome (p<0.2) will be included in a multivariable linear regression model to determine the adjusted associations of improved outcome from being in the treatment arm. A second model will use multi-levels (two levels: 1. time points for individuals, 2. individuals) to determine whether the trajectory of change in outcome scores differs between the two arms of the study. Significant predictors of improved outcomes will be determined from both of these models. A sensitivity analysis will be undertaken for final models based on degrees of compliance to home treatment using categories determined through exploratory analysis of the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Loading | Experimental | Procedure: Knee Loading protocolProgressive joint loading intervention will be taught by a program of exercises by the treating physiotherapist. The intervention consists of knee flexion (bending) and knee extension (straightening). Participants will be assessed for their immediate response to treatment during each assessment or treatment session and advised on the appropriate level of self-directed exercises to be performed twice daily. The clinician will review the patient at follow up appointments during the treatment period, progressing to the next level of exercises or by increasing intensity, duration or repetitions as appropriate. The physiotherapist will encourage compliance during the treatment period and beyond |
| Routine physiotherapy care | Active comparator | Procedure: Routine Physiotherapy CareNormal care delivered to the control group will be based on current NICE guidelines (2014) for non-pharmacological management of OA which includes verbal and written advice/education; education regarding weight loss; exercise to include local muscle strengthening and general aerobic fitness; with or without manual therapy. Clinicians will be asked to refrain from using the progression of techniques specifically documented in the progressive loading protocol (not currently considered to constitute 'normal care'). Treating clinicians will be asked to record specific exercises and manual therapy techniques employed in the patient's records. Participants will be asked to complete a home treatment record sheet. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to the Leeds Community Healthcare Musculoskeletal service aged 45 years or over with primary symptoms suggestive of degenerative intraarticular knee pain with a dominant mechanical presentation (i.e. activity related pain, functional limitation, morning stiffness not exceeding 30 minutes) AND
- Limitation in weightbearing range of motion of the knee joint (tibiofemoral joint limitation in flexion or extension)
Key exclusion criteria (5 listed)
- Subjects with cognitive impairment or medical conditions preventing understanding or participation in the study
- Subjects with symptoms requiring surgical evaluation or other intervention
- Knee symptoms related to pathology other than degenerative intraarticular pathology
- Subjects who are contraindicated from kneeling or crouching
- Subjects unable to attend the full study programme
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 |
|---|---|---|
| Knee Loading protocolThe clinician will review the patient at follow up appointments a further two to four times during the treatment period (dependent on symptom resolution/response), progressing to the next level of exercises or by increasing intensity, duration or repetitions as appropriate (each participant will be asked to maintain a home treatment diary sheet). The physiotherapist will encourage compliance during the treatment period and beyond. | Procedure or surgery | Knee Loading |
| Routine Physiotherapy CareRoutine Physiotherapy Care | Procedure or surgery | Routine physiotherapy care |
Primary outcome
Knee injury and Osteoarthritis Outcome score (KOOS)
Time frame: 6 and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Steven Foster principal investigator
Leeds Community Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Loading protocol and Routine Physiotherapy Care in people with Osteo Arthritis Knee, run by Leeds Comunity Healthcare NHS Trust at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 3 Jun 2015. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Foster (0113 8430247, steven.foster@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome score (KOOS) (time frame: 6 and 26 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 3 Jun 2015.