Clinical trial NCT03715764: Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Care
Official title: Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Health Care. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Physical Therapist
Primary assessor
Primary care
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-10-23
Enrollment: 69
Sex: ALL
Minimum age (years): 38
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to manage the future increase in osteoarthritis consultation, patients with osteoarthritis could be assessed by a physical therapist first, so that other patients with more severe conditions could get faster access to a primary care physician. In Swedish primary care, physicians and physical therapists are primary assessors for patients with suspected knee osteoarthritis. However, it is unclear if there are any differences between these managements in improving health-related quality of life (HrQoL), pain, physical function and self-efficacy.

There are a limited amount of studies about the impact on HrQoL, pain intensity, self-efficacy and physical performance in patients with knee pain being assessed and evaluated by a physical therapist as a primary assessor.

The overall purpose of this study is to evaluate the effects on self-rated HrQoL, pain intensity, self-efficacy and physical performance with either a physical therapist or a physician as primary assessor for patients with knee pain within primary health care.

Problem statements

Which effect does a clinical pathway with a physical therapist as primary assessor for patients with knee pain...

1. ... have on self-rated HrQoL compared with a physician as primary assessor?
2. ... have on self-rated pain intensity compared with a physician as primary assessor?
3. ... have on physical performance compared with a physician as primary assessor?
4. ... have on self-efficacy compared with a physician as primary assessor?

It is expected that this study will show the effects of two different primary assessors for patients with knee pain consulting primary health care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with knee pain in primary health care.

Detailed description: Patient Recruitment Recruiters: Primary care centers.

Screening procedure: Nurses at the primary care centers will get information about the study and the screening protocol from the data collector and project leader. There will be contact persons at each recruiting unit that will be responsible for the protocols and to contact the data collector when a patient fulfills all the criteria for participation. The project leader will have regular contact with the contact persons at the recruiting units. All screening protocols will be sent to the data collector. All participants will get orally and written information about the study from the data collector, and patients will provide written informed consent.

Randomization: Using a computer-generated list of random numbers, participants will be randomly assigned to being assessed, diagnosed and treated either by a physiotherapist or a physician first. A project coordinator is included among the health care providers in the study, but will not be involved in the screening procedure nor the data collection. The project coordinator will manage the sequence generation, allocation concealment, enrolment and assignments of participants and keep the concealed randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard (in the same building where the enrolment will be), only available for the project coordinator. The project coordinator reveals the allocation to the participant shortly after the baseline measurement and to the health care providers.

Participants and health care providers in both groups will be aware of the allocated group, whereas data collector, data analyst and statistician will be kept blinded of allocation until completion of all outcome assessments.

The blinded data collector and analyst (is a physical therapist) whom is not involved in assessing diagnosing and treating patients with knee osteoarthritis while the study is conducted.

Data Collection: Measurements will be collected at baseline (before randomization), at 3- , 6- , and at 12 months follow up.

Data management: All data will be coded and managed according to the Data Protection Act (1998:204), which means that all data will be confidential and no unauthorized will have access to the patient registry. The results will be presented at group level, therefore, no individual information can be identified. Data will be saved for at least 10 years to enable audit.

Sample size: To detect a minimal clinical improvement in health related quality of life of 0.121(SD 0.2) on the EQ5D-index, with a two-sided 5% significance level and a power of 80%, a sample size of 50 patients per group will be necessary, given an anticipated dropout rate of 14%.

Statistical analysis: Data will be analyzed descriptively and presented as numbers and percent, mean and standard deviation or median and 25th to 75th percentiles. The primary outcome will be mean change in HrQoL (EQ5D-index and EQ5D-scale) and secondary outcomes will include mean change in pain intensity (VAS), physical performance (30CST) and self-efficacy (ASES-S). The changes in scores for the outcomes will be constructed by calculating raw differences between baseline and the follow ups. For group comparison the Χ2-test will be used for nominal data and Fischer's exact test for small numbers, parametric student t-test for continuous variables and Mann-Whitney's test for ordinal data and at skewed distributions. Statistical analysis will be made in SPSS Windows and the analysis will be applied with intention-to-treat (ITT). The level of significance will be p\< 0.05.

Eligibility criteria: Inclusion Criteria:

* Age \>38 years old
* Knee pain most of the days the last month
* Crepitus on active motion
* Morning stiffness, duration less than 30 minutes
* The patient has to understand the Swedish language to follow test instructions and to complete the self-administered questionnaires.

Exclusion Criteria:

* Already been assessed/diagnosed by a healthcare provider for current knee pain.
* knee pain due to a traumatic cause
* other rheumatic or systemic diseases
* severe somatic or mental disease
* pregnancy.

Primary outcomes:
measure: Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index
timeFrame: 12 months
measure: Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS
timeFrame: 12 months
Secondary outcomes:
measure: Change From Pain Intensity at 12 Months
timeFrame: 12 months
measure: Change From Physical Function at 12 Months
timeFrame: 12 months
measure: Change From Self-efficacy at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Research & Development Centre Södra Älvsborg
name: Lena Nordeman, RPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
citation: Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
citation: Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
citation: Fransen M, Edmonds J. Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):807-13. doi: 10.1093/rheumatology/38.9.807.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
citation: Gill SD, de Morton NA, Mc Burney H. An investigation of the validity of six measures of physical function in people awaiting joint replacement surgery of the hip or knee. Clin Rehabil. 2012 Oct;26(10):945-51. doi: 10.1177/0269215511434993. Epub 2012 Feb 9.
citation: Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
citation: Ho CM, Thorstensson CA, Nordeman L. Physiotherapist as primary assessor for patients with suspected knee osteoarthritis in primary care-a randomised controlled pragmatic study. BMC Musculoskelet Disord. 2019 Jul 13;20(1):329. doi: 10.1186/s12891-019-2690-1.