Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Care

NCT03715764 | Completed Results

• 1 other identifier: 115841rct
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Physical Therapist; Primary assessor; Primary care

Outcome Measures

Primary Outcomes (2)

• Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index

  A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The questionnaire contain five dimensions and results in an index ranging from -0,549 to 1 using the UK tariffs. An index of 1 indicate full health.

  12 months

• Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS

  A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The EQ5D-VAS is a visual analogue scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best imaginable health state.

  12 months

Secondary Outcomes (3)

• Change From Pain Intensity at 12 Months

  12 months

• Change From Physical Function at 12 Months

  12 months

• Change From Self-efficacy at 12 Months

  12 months

Study Arms (2)

Physical therapy assessment

OTHER

Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to.

Other: Physical therapy assessment

Physician assessment

OTHER

Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician.

Other: Physician assessment

Interventions

Physical therapy assessment OTHER

Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.

Physical therapy assessment

Physician assessment OTHER

Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.

Physician assessment

Eligibility Criteria

• Age: 38 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Publications (8)

• 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.

  PMID: 25084132 BACKGROUND

• 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.

  PMID: 16110932 BACKGROUND

• 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.

  PMID: 10515649 BACKGROUND

• 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.

  PMID: 10515639 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• 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.

  PMID: 22324057 BACKGROUND

• 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.

  PMID: 3741515 BACKGROUND

• 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.

  PMID: 31301739 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

* Due to low participant inflow, the recruting was ended before reaching the required sample size of 100 patients. * Under powered study

Results Point of Contact

• Title: PhD-student, Chan-Mei Ho-Henriksson
• Organization: Region Västra Götaland, Närhälsan

chan-mei.ho@vgregion.se

+46709892821

Study Officials

• Lena Nordeman, RPT, PhD

  Research & Development Centre Södra Älvsborg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 23, 2018
• Study Start: April 1, 2013
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share