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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02454374
• Other study ID #: NP0159
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2015
• Last updated: June 2, 2015
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2015
• Source: Leeds Comunity Healthcare NHS Trust
• Contact: Steven Foster
• Phone: 0113 8430247
• Email: steven.foster[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Routine Physiotherapy Care
Routine Physiotherapy Care

Locations

Country	Name	City	State
United Kingdom	Leeds Musculosktal Servive	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Leeds Comunity Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome score (KOOS)		6 and 26 weeks	No