Clinical Course of Patients Receiving Physiotherapy Services in Primary Health Care

NCT03626389 | Completed

• 1 other identifier: FYSIOPRIM
• Study Type: observational
• Target: 4,985
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Physiotherapists (PTs) in primary health care manage patients with a large variation in medical diagnosis, age, functional status, disability and prognosis. Lack of knowledge and systematically collected data about patients treated by PTs in primary health care has prompted this longitudinal observational physiotherapy project in Norway. This paper aims to describe a method for developing a database of patients managed by PTs in primary health care to study patients' characteristics, treatment courses and prognostic factors. The study is a longitudinal observational project, following patients through physiotherapy treatment periods in primary health care in Norway and until one year after inclusion. The project involves both private practice and municipally employed PTs working in primary health care in eight municipalities in Norway. The participants are recruited to three different parts of the project depending on age and whether they are referred to a private practice or a municipally employed PT. All data are recorded electronically, transferred and stored securely. All patients complete extensive questionnaires providing information about demographics, disability and function, pain related variables, treatment and evaluation of treatment as well as clinical tests. The PTs have access to their own patients' data. The investigators have also prepared for linkage to national patient registers and population-based studies to be able to gather further important data. This project will have important implications for physiotherapy services in primary health care. The database already contains almost 3000 patients, and data collection is ongoing. Preliminary analyses suggest that the patients included so far are representative of the larger population of patients treated by private practice or municipally employed PTs in Norway. This large scale prospective physiotherapy project will provide knowledge about the patient groups treated, treatment given as well as short and long term outcome of the patients.

Conditions

Musculoskeletal Diseases or Conditions; Neurologic Disorder; Widespread Chronic Pain; Psychosomatic Disorder; Arthritis; Injuries

Keywords

physiotherapy; primary health care setting

Outcome Measures

Primary Outcomes (4)

• Change in Health-Related Quality of LIfe - assessed by EuroQual 5 Dimensions questionnaire (EQ-5D)

  Utility measure of Health related quality of life. Range -0.59 (worst) to 1 (best)

  Baseline, 3, 6 and 12 months

• Change in Patient-Specific Functional Scale (PSFS)

  Participants identify activities that are difficult to perform and scores them from 0 (cannot perform) to 10 (perform without problems)

  Baseline, 1, 3, 6 and 12 months

• General Perceived Effect

  A global assessment of change- 7 level scale. Score range 1 (very much better) to 5 (very much worse)

  3, 6 and 12 months

• Change in Pain intensity

  Pain intensity assessed by a numeric rating scale. Range 0 (no pain) to 10 (worst imaginable)

  Baseline, 1, 3, 6 and 12 months

Secondary Outcomes (27)

• Change in Work participation

  Baseline, 3, 6 and 12 months

• Change in work ability

  Baseline, 3, 6 and 12 months

• Change in pain distribution

  Baseline, 3, 6 and 12 months

• Change in use of analgesics containing paracetamol

  Baseline, 3, 6 and 12 months

• Change in use of analgesics containing ibuprofen

  Baseline, 3, 6 and 12 months

Study Arms (1)

Patients receiving physiotherapy in primary care

Physiotherapy, without predetermined selection of specific modalities

Other: Physiotherapy

Interventions

Physiotherapy OTHER

Patients receiving physiotherapy in primary care

Eligibility Criteria

• Age: 0 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients are recruited through physiotherapists in primary health care.

You may qualify if:

• any patient seeking or receiving physiotherapy services in primary health care

You may not qualify if:

• Not understanding Norwegian or English language

Sponsors & Collaborators

• University of Oslo: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator
• Norwegian University of Science and Technology: collaborator
• Trondheim Kommune: collaborator

Study Sites (2)

Approx 100 physiotherapists in Norway

Oslo, Norway

Location

Physiotherapists in Trondheim

Trondheim, Norway

Location

Related Publications (5)

• Handeland H, Evensen KAI, Robinson HS. Focus on physiotherapy and manual therapy for infants in Norway, a cross-sectional study on referral practice, and planned interventions. BMC Pediatr. 2025 Apr 9;25(1):282. doi: 10.1186/s12887-025-05627-3.

  PMID: 40205420 DERIVED

• Unsgaard-Tondel M, Vasseljen O, Nilsen TIL, Myhre G, Robinson HS, Meisingset I. Prognostic ability of STarT Back Screening Tool combined with work-related factors in patients with low back pain in primary care: a prospective study. BMJ Open. 2021 Jun 3;11(6):e046446. doi: 10.1136/bmjopen-2020-046446.

  PMID: 34083340 DERIVED

• Amundsen O, Vollestad NK, Meisingset I, Robinson HS. Associations between treatment goals, patient characteristics, and outcome measures for patients with musculoskeletal disorders in physiotherapy practice. BMC Musculoskelet Disord. 2021 Feb 13;22(1):182. doi: 10.1186/s12891-021-04048-4.

  PMID: 33583404 DERIVED

• Evensen KAI, Sellaeg S, Straete AC, Hansen AE, Meisingset I. Profile of children referred to primary health care physiotherapy: a longitudinal observational study in Norway. BMC Health Serv Res. 2021 Jan 6;21(1):16. doi: 10.1186/s12913-020-05988-8.

  PMID: 33407440 DERIVED

• Evensen KAI, Robinson HS, Meisingset I, Woodhouse A, Thielemann M, Bjorbaekmo WS, Myhre G, Hansen AE, Vasseljen O, Vollestad NK. Characteristics, course and outcome of patients receiving physiotherapy in primary health care in Norway: design of a longitudinal observational project. BMC Health Serv Res. 2018 Dec 4;18(1):936. doi: 10.1186/s12913-018-3729-y.

  PMID: 30514287 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Nervous System Diseases; Chronic Pain; Psychophysiologic Disorders; Arthritis; Wounds and Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Nina K Vøllestad, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 13, 2018
• Study Start: June 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: We plan to share data from 1 January 2019 and until our approval for use of data expires.
• Access Criteria: Quality of proposal Scientific publication required as output to researchers Reports or white papers required as output to managers Financial support to carry out the project No conflict with ongoing research based on the data The use is in keeping with research ethical standards and regulations for use of personal data

Locations

NO (2)