Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1)

June 2, 2015 updated by: Leeds Comunity Healthcare NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Limitation in weightbearing range of motion of the knee joint (tibiofemoral joint limitation in flexion or extension)

Exclusion Criteria:

  1. Subjects with cognitive impairment or medical conditions preventing understanding or participation in the study
  2. Subjects with symptoms requiring surgical evaluation or other intervention
  3. Knee symptoms related to pathology other than degenerative intraarticular pathology
  4. Subjects who are contraindicated from kneeling or crouching
  5. Subjects unable to attend the full study programme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Knee Loading
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
Procedure: Knee Loading protocol
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.
Active Comparator: Routine physiotherapy care
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.
Procedure: Routine Physiotherapy Care
Routine Physiotherapy Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Knee injury and Osteoarthritis Outcome score (KOOS)
Time Frame: 6 and 26 weeks
6 and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leeds Comunity Healthcare NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Foster, Leeds Community Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP0159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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