An interventional study of Manual terapeut management in Backpain and Neck and Shoulder Pain, sponsored by Karolinska Institutet. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Health services research
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;
Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.
Many visits to primary healthcare centers (PHCs) concern neck and/or back pain (NBP). Evidence-based clinical guidelines are often not considered, and low-value care, including unnecessary imaging, prescription of medications, injections, unnecessary surgery, and sick leave, is instead used, leading to poor patient outcomes and high societal costs. The primary healthcare system is severely pressured, and there is a need to reduce the burden of this common patient group on the physicians. Licensed naprapaths and chiropractors (manual therapist (MT)) have been part of Swedish healthcare for >30 years, but their competence is seldom utilized at PHCs. MT as first-contact providers within PHCs may reduce the burden of NBP in the population by improving adherence to evidence-based guidelines, reducing the workload on physicians, minimizing unnecessary healthcare procedures, and reducing expenditure.
Patient reported outcomes include pain, function, work ability and satisfaction, and health economy are based on sickness absence, care consumption, referrals and pharmaceutical use will be compared between groups.
Our hypothesis is that the intervention will lead to symptom improvement and work ability, as well as decrease the risk of sickness absence and low value care (sickness absence, care consumption, referrals and pharmaceutical use) for these patients. Thus, we hypothesize positive consequences for the individual and for society.
Advanced epidemiological/statistical methods address confounding when comparing the groups. Physicians' and patients' experiences, facilitators, and barriers to the implementation of the intervention will also be studied.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's planned enrollment of 600 is above the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention in the index group is a triage performed by the licensed manual therapist, MT: take the anamnesis, perform a clinical assessment and examination (including assessment of fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to evidence-based clinical guidelines, i.e., high-value care. In summary, these guidelines state that patients with no "Red flags" (signs of pathology) or "Yellow flags" (psychological risk factors such as unrealistic beliefs about their pain, catastrophizing, kinesiophobia) shall self-manage when they are adequately informed about their condition and that they need to continue with their usual activities, such as work, physical activity, and social life. The role of the MT is to triage patients according to the best evidence into three groups: those with little or no risk of persistent pain, those with a moderate risk, and those with a substantial risk of a bad prognosis.
Other: Manual terapeut management
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.
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
Chronic pain
Time frame: 12 months
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
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
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
Work Ability
Measures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job
Time frame: 12 months
sickness absence
The number of days an individual has been off work because of neck and back pain
Time frame: 12 months
Quality of the assessment by manual therapists
A qualitative outcome collected in interviews with healthcare personell and patients
Time frame: 12 months
Plan to share: Undecided — In the planning stages of the trial, we have not taken measures to share data. This is due to our ethical permission.
Start is estimated for Nov 2026; primary completion for Aug 2030, 45 months later.
Of 259 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 45 months is above that.
Counting every sponsor, half of 294 studies reached it within 13 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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