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

Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Health Care. A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03715764
Enrollment
69
Registered
2018-10-23
Start date
2013-04-01
Completion date
2017-10-20
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis, Physical Therapist, Primary assessor, Primary care

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.

Interventions

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

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

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
38 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index12 monthsA 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.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS12 monthsA 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.

Secondary

MeasureTime frameDescription
Change From Pain Intensity at 12 Months12 monthsThe mean pain intensity (over the past month) will be measured by a visual analogue scale (VAS) ranged from 0 which will correspond no pain and 100 the worst imagined pain.
Change From Physical Function at 12 Months12 monthsPhysical performance will be measured with 30 seconds chair stand test (30CST). Number of chair stands will be counted.
Change From Self-efficacy at 12 Months12 monthsSelf-efficacy will be assessed with Arthritis Self-Efficacy Scale-Swedish version (ASES-S). Each question range from 10-100, where 10 is very insecure and 100 is very confident. The questionnaire consists three subscales in how patients are experiencing their 1) pain, 2) physical function, 3) other symptoms. Each subscale results in a mean score ranging from 10 to 100 where 10 means very insecure and 100 means very confident. The results of this outcome measure has not been analysed for publication. This outcome measure were excluded in the first manuscript when submitted to scientific journal and will probably be reported in a second manuscript. Anticipated reporting date is December 2024.

Participant flow

Pre-assignment details

Assessed for eligibility (n=363) Excluded (n=294) * Not meeting inclusion criteria (n=185) * Declined to participate (n=15) * Excluded due to exclusion criteria (n=94)

Participants by arm

ArmCount
Physical Therapy Assessment
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. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.
35
Physician Assessment
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. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
34
Total69

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month Follow-upChanged primary care centre01
12 Month Follow-upLost to Follow-up23
12 Month Follow-upNo symptoms10
12 Month Follow-upPregnancy01
12 Month Follow-upSurgery20
12 Month Follow-upWrong address10
3 Month Follow-upLost to Follow-up22
3 Month Follow-upWithdrawal by Subject11
6 Month Follow-upLost to Follow-up30
Baseline (Randomized (n=69)Withdrawal by Subject23

Baseline characteristics

CharacteristicPhysician AssessmentTotalPhysical Therapy Assessment
Age, Continuous59 years
STANDARD_DEVIATION 11.5
60 years
STANDARD_DEVIATION 11.6
62 years
STANDARD_DEVIATION 11.6
BMI29 kg/m^2
STANDARD_DEVIATION 6.7
29 kg/m^2
STANDARD_DEVIATION 5.6
30 kg/m^2
STANDARD_DEVIATION 4.4
Current Employment
Employed/working
18 Participants37 Participants19 Participants
Current Employment
Retired/early retirement
13 Participants28 Participants15 Participants
Current Employment
Sick leave
2 Participants3 Participants1 Participants
Current Employment
Unemployed
1 Participants1 Participants0 Participants
Health-related quality of life (EQ5D-index)0.62 units on a scale
STANDARD_DEVIATION 0.222
0.67 units on a scale
STANDARD_DEVIATION 0.185
0.73 units on a scale
STANDARD_DEVIATION 0.121
Health-related quality of life (EQ5D-VAS)68 units on a scale
STANDARD_DEVIATION 21.1
70 units on a scale
STANDARD_DEVIATION 19.5
73 units on a scale
STANDARD_DEVIATION 17.5
Level of education
Primary school
4 Participants12 Participants8 Participants
Level of education
Secondary school
20 Participants35 Participants15 Participants
Level of education
Tertiary school
10 Participants22 Participants12 Participants
Pain duration (months)10 months
STANDARD_DEVIATION 16
12 months
STANDARD_DEVIATION 19
14 months
STANDARD_DEVIATION 22
Pain intensity (VAS 0-100)52 units on a scale.
STANDARD_DEVIATION 16.4
49 units on a scale.
STANDARD_DEVIATION 16.5
45 units on a scale.
STANDARD_DEVIATION 15.9
Physical function (30 CST)11 Chair stands
STANDARD_DEVIATION 3.3
12 Chair stands
STANDARD_DEVIATION 4.1
12 Chair stands
STANDARD_DEVIATION 4.6
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
23 Participants44 Participants21 Participants
Sex: Female, Male
Male
11 Participants25 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 34
other
Total, other adverse events
0 / 350 / 34
serious
Total, serious adverse events
0 / 350 / 34

Outcome results

Primary

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.

Time frame: 12 months

Population: Mixed effect model analyses were used to compare the repeated measures of HrQoL between groups. Presenting the estimated marginal means for the final model (adjusted for confounders) at the 12 month follow-up.

ArmMeasureValue (MEAN)Dispersion
Physical Therapy AssessmentChange From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index0.804 score on a scaleStandard Error 0.025
Physician AssessmentChange From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index0.825 score on a scaleStandard Error 0.024
p-value: 0.87Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.18Mixed Models Analysis
Primary

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.

Time frame: 12 months

Population: Mixed effect model analyses were used to compare the repeated measures of HrQoL between groups. Presenting the estimated marginal means for the final model (adjusted for confounders) at the 12 month follow-up.

ArmMeasureValue (MEAN)Dispersion
Physical Therapy AssessmentChange From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS81 score on a scaleStandard Error 2.55
Physician AssessmentChange From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS77 score on a scaleStandard Error 2.49
p-value: 0.56Mixed Models Analysis
p-value: 0.0049Mixed Models Analysis
p-value: 0.49Mixed Models Analysis
Secondary

Change From Pain Intensity at 12 Months

The mean pain intensity (over the past month) will be measured by a visual analogue scale (VAS) ranged from 0 which will correspond no pain and 100 the worst imagined pain.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Physical Therapy AssessmentChange From Pain Intensity at 12 Months21.79 units on a scaleStandard Deviation 18.59
Physician AssessmentChange From Pain Intensity at 12 Months23.29 units on a scaleStandard Deviation 18.87
p-value: <0.2Mixed Models Analysis
Secondary

Change From Physical Function at 12 Months

Physical performance will be measured with 30 seconds chair stand test (30CST). Number of chair stands will be counted.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Physical Therapy AssessmentChange From Physical Function at 12 Months15 standsStandard Deviation 4.9
Physician AssessmentChange From Physical Function at 12 Months15 standsStandard Deviation 5.8
p-value: <0.2Mixed Models Analysis
Secondary

Change From Self-efficacy at 12 Months

Self-efficacy will be assessed with Arthritis Self-Efficacy Scale-Swedish version (ASES-S). Each question range from 10-100, where 10 is very insecure and 100 is very confident. The questionnaire consists three subscales in how patients are experiencing their 1) pain, 2) physical function, 3) other symptoms. Each subscale results in a mean score ranging from 10 to 100 where 10 means very insecure and 100 means very confident. The results of this outcome measure has not been analysed for publication. This outcome measure were excluded in the first manuscript when submitted to scientific journal and will probably be reported in a second manuscript. Anticipated reporting date is December 2024.

Time frame: 12 months

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026