Kalevala traditional manual therapy for chronic low back pain: comparing its benefits to physiotherapy and health‑coaching‑supported care

ISRCTN	ISRCTN13717352
DOI	https://doi.org/10.1186/ISRCTN13717352
Sponsors	University of Eastern Finland, Kalevala Folk Healing Foundation, Advisory Board for Traditional Therapies
Funder	The Ministry of Finance of Finland

Submission date: 02/03/2026
Registration date: 02/03/2026
Last edited: 02/03/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic low back pain (CLBP) is a major global cause of disability, and its management requires a biopsychosocial approach. The World Health Organization (2023) guidelines emphasize non-surgical interventions such as physiotherapy, patient education, and psychological support. In Finland, Kalevala Traditional Manual Therapy is a traditional manual therapy, the effects of which on pain and functional ability have been reported in pilot studies. Health coaching supports behavior change and may improve treatment outcomes. The aim of this study is to evaluate the effectiveness of Kalevala Traditional Manual Therapy and its combination with health coaching in the treatment of chronic low back pain, compared to physiotherapy.

Who can participate?
Adults (aged 18 years and over) who have experienced low back pain for at least 12 weeks without significant recovery

What does the study involve?
The treatment period lasts 8 weeks, with follow-up conducted at 6 months. Participants will attend a total of six study visits, including:
1. Baseline assessments, conducted over two visits: the first visit lasts approximately 60 minutes and the second approximately 30 minutes
2. Post-treatment assessments, conducted over two visits, each lasting approximately 30 minutes
3. Follow-up assessments, conducted over two visits, each lasting approximately 30 minutes
The number and content of treatment sessions vary depending on group allocation:
1. Physiotherapy group: three guidance sessions (30–60 min)
2. Kalevala Traditional Manual Therapy group: three Kalevala bone setting treatments (90 min)
3. Kalevala Traditional Manual Therapy and Health coaching: 3 Kalevala Traditional Manual Therapy (90 min) and six health coaching sessions (30 min, by phone)
In addition, participants included in the acute effects measurements will undergo assessments 30 minutes before and again 30 minutes after the first treatment session.

What are the possible benefits and risks of participating?
It is possible that you will not benefit directly from participating in this study. However, the knowledge gained may help determine whether Kalevala Traditional Manual Therapy, either alone or combined with health coaching, is an effective treatment for chronic low back pain compared to physiotherapy.
The results may contribute to the development of cost-effective and patient-centered care models, inform clinical guidelines, and improve participants’ pain, functional ability, quality of life, and physical activity. In this study, potential risks are generally mild and transient. Kalevala Traditional Manual Therapy may cause temporary pain or slight swelling, but serious adverse effects are very rare. Physiotherapy exercises may cause temporary muscle soreness, as is typical after exercise. The measurements are painless and do not pose any risk. Answering psychological questionnaires may evoke emotions, but participation in these is voluntary.

Where is the study run from?
University of Eastern Finland (Finland)

When is the study starting and how long is it expected to run for?
March 2026 to December 2028

Who is funding the study?
The Ministry of Finance (Finland)

Who is the main contact?
Mika Venojärvi, mika.venojarvi@uef.fi

Contact information

Dr Mika Venojärvi
Principal investigator, Scientific, Public

University of Eastern Finland, Yliopistonrinne 8
Kuopio
70210
Finland

ORCID ID	0000-0003-1327-9760
Phone	+358 (0)403552248
Email	mika.venojarvi@uef.fi

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care, Treatment
Scientific title	Kalevala traditional manual therapy as an independent therapy and integrated into health coaching compared with physiotherapy‑based care in the management of chronic low back pain: a randomized controlled trial
Study acronym	Kalevala
Study objectives	The aim of the study is to evaluate whether Kalevala Traditional Manual Therapy (KTMT), either as a standalone intervention or combined with health coaching, is as effective or more effective than physiotherapeutic treatment in individuals with chronic low back pain. The study also examines the number of sick-leave days and the use of medications 6 months after the completion of the intervention. In addition, the acute effects of both physiotherapeutic treatment and KTMT are assessed. Research questions: 1. Does Kalevala Traditional Manual Therapy reduce pain and improve functional capacity more effectively than physiotherapeutic treatment? 2. Does the combination of Kalevala Traditional Manual Therapy and health coaching produce a greater treatment response than Kalevala Traditional Manual Therapy alone or physiotherapeutic treatment? 3. Do the interventions influence physical activity, quality of life, mood, and sleep quality during the 8‑week treatment period and the 6‑month follow‑up? 4. Is the treatment response associated with changes in fear‑avoidance behaviors and physical activity? 5. Does Kalevala Traditional Manual Therapy, either alone or combined with health coaching, reduce the number of sick‑leave days and the use of analgesic medications compared with physiotherapeutic treatment during the 6‑month follow‑up? 6. Do the immediate effects of physiotherapeutic guidance and Kalevala Traditional Manual Therapy differ in terms of autonomic nervous system function, pain, tissue temperature distribution, muscle stiffness, lumbar spine mobility, mood, hydration status, stress level, and swelling when measured immediately before and after the first treatment session?
Ethics approval(s)	Approved 27/02/2026, The Regional Medical Research Ethics Committee of Eastern Finland Collaborative Area (Pohjois-Savon hyvinvointialue, Puijonlaaksontie 2, Kuopio, 70211, Finland; + 358 (0)44 717 2102; tutkimuseettinentoimikunta@pshyvinvointialue.fi), ref: 62/2026 (207/2025)
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	This study is a randomized, controlled, three‑arm intervention trial with an 8‑week treatment period and a 6‑month follow‑up. Participants are randomized into three groups (n = 35 per group). Randomization will be performed using a computer-assisted block method to ensure balance (age, sex) after the first study visit. 1. Physiotherapy (FT) The physiotherapy program consists of three supervised physiotherapy sessions delivered during study weeks 1 (45–60 minutes), 3 (30 minutes), and 6 (30 minutes). During the remaining weeks, participants continue the exercises at home according to the physiotherapist’s instructions. The program includes therapeutic exercises such as mobility, motor‑control, core‑stabilization, and strength‑training exercises, which are individually selected to support lumbar spine function. In addition, the home‑exercise program includes aerobic activity, such as walking, which is progressively increased over the course of the program. The physiotherapy intervention is progressive, meaning that the volume and difficulty of the exercises are gradually increased while taking into account functional capacity and safety. 2. Kalevala Traditional Manual Therapy (KTMT) Participants receive three KTMT treatment sessions over the 8‑week period. The manual therapy applied in the study is a gentle, non‑invasive soft‑tissue approach designed to support the body’s natural mobility and balance. The treatment proceeds from the lower body toward the upper body in the following sequence: feet and ankles, lower legs, knees, thighs and hips, sacral and back region, upper limbs, and the head and cervical spine. The techniques consist of soft, slow, tissue‑responsive manual strokes intended to facilitate normal tissue movement, fluid circulation, and functional balance. The treatment does not include manipulations or high‑force techniques. Each session lasts approximately 90 minutes. 3. Kalevala Traditional Manual Therapy + Health Coaching (KTMT+HC) Participants receive three KTMT sessions as described above, together with six health‑coaching sessions. The coaching is delivered by phone for approximately 30 minutes per week during study weeks 1, 2, 3, 5, 6, and 7. The content focuses on key themes relevant to low‑back‑pain management: understanding the biopsychosocial model of back pain, reducing fear‑avoidance behaviors, increasing physical activity and functional capacity, strengthening individualized pain‑management strategies, and supporting home exercises. During the first treatment session, the acute effects of physiotherapy guidance (45–60 min) (n = 30) and Kalevala Traditional Manual Therapy (90 min) (n = 30) are assessed on autonomic nervous system function, pain, tissue temperature distribution, muscle stiffness, lumbar spine mobility, mood, fluid balance, stress level, and swelling, immediately before and after the treatment.
Intervention type	Mixed
Primary outcome measure(s)	Pain intensity measured using the Visual Analogue Scale (VAS) at baseline, 8 weeks, 6‑month follow‑up Disability related to low back pain measured using the Oswestry Disability Index (ODI) at baseline, 8 weeks, 6‑month follow‑up
Key secondary outcome measure(s)	Quality of life measured using the RAND 36 Health Survey at baseline, 8 weeks, 6 month follow up Mood measured using the Positive and Negative Affect Schedule (PANAS) at baseline, 8 weeks, 6 month follow up Fear avoidance behavior measured using the Fear Avoidance Beliefs Questionnaire (FABQ) at baseline, 8 weeks, 6 month follow up Function measured using the Patient-Specific Functional Scale (PSFS) at baseline, 8 weeks, 6 month follow up Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, 8 weeks, 6 month follow up Physical activity measured using the Global Physical Activity Questionnaire (GPAQ) at baseline, 8 weeks, 6 month follow up Flexibility measured using the Fingertip to Floor Test (FTF) at baseline, 8 weeks, 6 month follow up Lumbar flexion mobility measured using the Modified Schober Test (MST): at baseline, 8 weeks, 6 month follow up Postural stability measured using the Romberg Test at baseline, 8 weeks, 6 month follow up Muscle mechanical properties: muscle stiffness, tone (frequency), and elasticity (decrement) measured using a Myoton device at baseline, 8 weeks, 6 month follow up Depressive symptoms measured using the Beck Depression Inventory (BDI) at baseline, 8 weeks, 6 month follow up Sickness absence measured using the total number registry verified sick leave days at 6 month follow up Use of analgesic medications measured using registry verified logs documenting type, dose, and frequency of pain medication use at 6 month follow up
Completion date	31/12/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	105
Key inclusion criteria	1. Aged over 18 years 2. Chronic low back pain (>12 weeks) 3. Start Back Screening Tool score >3 4. Ability to participate in the treatment and follow‑up period
Key exclusion criteria	1. Pregnancy 2. Cardiac pacemaker or metallic prosthesis 3. Rheumatic diseases 4. Severe structural deformity 5. Previous spinal surgery 6. Acute disc herniation or severe sciatica
Date of first enrolment	09/03/2026
Date of final enrolment	30/08/2026

Locations

Countries of recruitment

Finland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

02/03/2026: Study's existence confirmed by the Regional Medical Research Ethics Committee of Eastern Finland Collaborative Area.