Clinical trial NCT02454374: Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1)
Official title: Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Physiotherapy
Knee Loading
Randomised Controlled Trial
Pain
Lead sponsor: Leeds Comunity Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 144
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome score (KOOS)
timeFrame: 6 and 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Musculosktal Servive
Study officials:
affiliation: Leeds Community Healthcare NHS Trust
name: Steven Foster
role: PRINCIPAL_INVESTIGATOR
References: