Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKarolinska Institutet

About this trial

The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain.

A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used.

Neck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year;

* 300 patients with care as usual who see their physician (control group), * 300 patients who see a licensed naprapath/chiropractor for an initial evidence-based assessment/screening before the physicians' visit.

Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18-70 years, with an appointment with a physician at the primary health care center for a new episode of pain or discomfort in the neck, mid-back or lower back with or without radiating symptoms to the head, arms, or leg

Disqualifiers

Sick-leave for neck- and backpain the preceding three months (at least 50%), having consulted or been treated by licensed healthcare provider for neck- and backpain during the preceding three months, and not mastering the Swedish language

Trial design

Design model

Sequential

Treatments tested in this trial

  • Manual terapeut management

    Other intervention

    The intervention in the index group is a triage performed by the licensed manual teerapeut: take the anamnesis, perform a clinical and assessment formula examination (fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to current evidence-based clinical guidelines. The outcome in this intervention arm will be compared to study participants with "care as usal" included in sthe study earlier.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: MT managementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient-perceived Global Perceived Effect

This outcome is measured through a Lickert scale. The single question is: "compared with the start of the trial, how is your \[condition\] today?" Answers from "completely recovered" to "much worse"

Time frame
12 months

Secondary outcomes

1

Chronic pain

Time frame
12 months
2

Activity limitations

Roland Morris disability questionnaire, Nordic pain questionnaire. These are validated instruments assessing the influence of the condition on everyday activities. Example "my \[condition\] prevents me from doing household chores" -agree/do not agree. The instrument then results in a score where high scores mean that the condition highly affects daily activities.

Time frame
12 months
3

Health-related quality of life

EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).

Time frame
12 months
4

Societal costs

Cost related to care consumption, sick-leave, referrals and pharmaceuticals. Self-reported every three months, participants are reporting all care relating to their condition, number of care visits and cost of visits. Travel time is attributed to each care visit. This will also include visits to specialists. They are reporting the number of days they have been off work due to the condition, and all type of medication consumed for their condition.

Time frame
12 months

Other outcomes

1

Quality of the assessment by manual therapists

A qualitative outcome collected in interviews with healthcare personell and patients

Time frame
12 months

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Sophiahemmet University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: