Osteopathy Versus Physiotherapy for Chronic Low Back Pain, Warsaw Poland

Trial Review

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Registration number

ACTRN12626000521325 Ethics application status

Approved Date submitted

13/11/2025 Date registered

28/04/2026 Date last updated

28/04/2026 Date data sharing statement initially provided

28/04/2026 Type of registration

Retrospectively registered
Titles & IDs Public title Is osteopathy or conventional physiotherapy more effective in patients with non-specific chronic lumbosacral pain. Query! Scientific title Evaluation of the results of osteopathy and conventional physiotherapy on pain and mobility in patients with non-specific chronic lumbosacral pain. Query! Additional trial identifiers [1] 315778 0 none Query! Universal Trial Number (UTN) Query! Trial acronym Query! Related trial records Query!
Health condition Health condition(s) studied: Low back pain 339522 0 Query! Condition category Condition code Musculoskeletal 335771 335771 0 0 Query! Other muscular and skeletal disorders Query!

Physical Medicine / Rehabilitation 335776 335776 0 0 Query! Physiotherapy Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure Assignment to one of the groups was not based on any of the methods listed (tab “i”).  Patients could choose between facility A and facility B and decided for themselves which one to enroll in, without knowing what type of therapy they would receive there. One facility used osteopathic methods and the other used physiotherapy.
Group A was treated at the Department of Rehabilitation at the University Clinical Center of the Medical University of Warsaw. Group B was treated at the Healthcare Facility “ORTO” Rehabilitation-Medical Center in Warsaw. Both groups were treated on an outpatient basis.
Group A patients underwent a 15–20-day rehabilitation regimen including 10 sessions of: 1. Iontophoretic application of hydrocortisone onto and around triger points,
Hydrophilic sponge pads were used for the procedure. 100 mg of hydrocortisone dissolved in 15 ml of sterile water was used for the procedure.
The dose of electric current depends on the individual sensitivity of the patient: Intensity density: The standard range is 0.05 to 0.2 mA per 1 cm² of active electrode surface area.
Duration time 20 minutes.
The physiotherapist used direct observation to monitor the course and effects of therapy.
The patient had to participate in at least 8 treatments.
2. Magneto therapy for lumbar spine area,
Magnetronic MF-12. Frequency 40Hz, duration time 20 minutes
The physiotherapist used direct observation to monitor the course and effects of therapy.
The patient had to participate in at least 8 treatments.
3. Physical exercises including relaxation positions and strengthening exercises. Rehabilitation was delilvered by experienced physical therapists.
Patients were taught to perform exercises for at least one 30–45 minute session per day.
Patients were taught face-to-face and could perform the exercises at the clinic or at home, or both.
Depending on the patient's fitness level, the intensity of the exercises could be increased. The physical therapist assessed how much effort the patient put into the exercises. If he saw that the patient had reserves, he increased the intensity.
Examples of exercise:
Relaxation position as chair-like position - In this position, we get traction of the lumbar spine and relief by shortening the ilio-psoas muscles.
Strengthening exercise as bird-dog:
Starting position: patient in a kneeling position. head should be in line with a spine.
Execution: exhale while lifting and straightening the opposite limbs (right leg and left arm). After that inhale, return to the starting position, and perform another repetition. After completing the entire series, switch limbs.
Another exercise is plank. We can do classic plank or side plank.
To make the exercise effective and safe for your lumbar spine, remember to keep your pelvis in a neutral position (tailbone tucked in) and actively push off the ground to avoid your shoulder blades “sinking.”
The physiotherapist used direct observation to monitor the course and effects of therapy.
The patient had to participate in at least 8 exercise sessions.
Query! Intervention code [1] 332399 0 Rehabilitation Query! Intervention code [2] 332938 0 Treatment: Other Query! Intervention code [3] 332939 0 Treatment: Devices Query! Description of the comparator or control All patients from group B (control group) underwent 5–10 sessions (the duration of each session is 40 minutes) of osteopathic manipulation therapy (manual osteopathy) provided in short intervals over a period of 20±5 days. Osteopathy treatment was conducted by an osteopath with 10 years of experience.
During each session the osteopath verified the recommendations for correct ergonomics and appropriate exercises. The patient needs to attend at least five therapeutic sessions.

Query! Control group Active Query!
Outcomes Primary outcome [1] 343311 0 The primary objective of the study was to determine the type of changes in the severity of lower back pain in both groups of patients just after treatment. Query! Timepoint [1] 343311 0 Patients were asked to complete the VAS test before treatment and just after treatment. Query! Secondary outcome [1] 453948 0 The secondary objective of the study was to determine the type of changes in the severity of lower back pain in both groups of patients 3 months after treatment. Query! Timepoint [1] 453948 0 Patients were asked to complete the VAS test before treatment and 3 months after treatment. Query!
Eligibility Key inclusion criteria - Informed consent of the patient to participate in the study.
- No contraindications to physiotherapy or manual therapy.
- Pain in the lumbo-sacral region of the spine lasting < 3 months.
- Pain intensity in the lumbo-sacral region on the VAS scale between 3 and 10.
- X-ray, MRI, or CT scan of the L–S spine attached.
- Pain as a result of osteoarthritis.
- Age range 35–65 years.
- No noticeable neurological deficits (e.g., peripheral paresis of the lower limbs, impaired bladder or anal sphincter function, potency disorders).
- Consultation with an orthopedic specialist or medical rehabilitation specialist. Query! Minimum age 35 Years Query! Query! Maximum age 65 Years Query! Query! Sex Both males and females Query! Can healthy volunteers participate? No Query! Key exclusion criteria - Lack of informed consent from the patient to participate in the study.
- Age < 35 or > 65 years.
- Contraindications to physical or manual treatment.
- Circulatory and respiratory disfunction?
- History of cancer.
- Recent spinal injuries (< 6 months).
- Condition after spinal surgery due to degenerative changes.
- Unstable hypertension, coronary artery disease.
- Poorly controlled diabetes.
- Vestibular disorders.
Query!
Study design Purpose of the study Treatment Query! Allocation to intervention Non-randomised trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Query! Masking / blinding Blinded (masking used) Query! Who is / are masked / blinded? The people receiving the treatment/s
The people administering the treatment/s

Query! Query! Query! Query! Intervention assignment Parallel Query! Other design features Query! Phase Not Applicable Query! Type of endpoint/s Efficacy Query! Statistical methods / analysis The data set was analyzed using the SAS 9.2 interface. This allowed for descriptive analysis including: means, standard deviations, medians, lower and upper quartiles. In the first stage, correlations between variables were calculated using Spearman's correlation coefficients. Nonparametric tests were also used in the analysis: U–Mann–Whitney, Kruskall–Wallis (for multiple comparisons), Wilcoxon (comparison of two dependent data samples). The chi-square test was also used to compare discrete data. In order to determine the significance of differences between factors, ANOVA with repeated measurements and Friedman's ANOVA were used. In all statistical analyses, the significance level was set at p<0.05.
Query!
Recruitment Recruitment status Completed Query! Date of first participant enrolment Anticipated Query! Actual 31/03/2017 Query! Date of last participant enrolment Anticipated Query! Actual 1/10/2021 Query! Date of last data collection Anticipated Query! Actual 25/02/2022 Query! Sample size Target 102 Query! Accrual to date Query! Final 84 Query! Recruitment outside Australia Country [1] 27555 0 Poland Query! State/province [1] 27555 0 Masovian Voivodeship Query!
Funding & Sponsors Funding source category [1] 320389 0 Self funded/Unfunded Query! Name [1] 320389 0 Kamil Slusarz, Healthcare Facility “ORTO” Rehabilitation-Medical Center in Warsaw Query! Country [1] 320389 0 Poland Query! Funding source category [2] 320911 0 Hospital Query! Name [2] 320911 0 Central Clinical Hospital in Warsaw Query! Country [2] 320911 0 Poland Query! Primary sponsor type Individual Query! Name Kamil Slusarz, Healthcare Facility “ORTO” Rehabilitation-Medical Center in Warsaw Query! Address Query! Country Poland Query! Secondary sponsor category [1] 322981 0 University Query! Name [1] 322981 0 Medical University of Warsaw Central Clinical Hospital in Warsaw Query! Address [1] 322981 0 Query! Country [1] 322981 0 Poland Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 318932 0 Bioethics Committee of the Medical University of Warsaw Query! Ethics committee address [1] 318932 0 Sekretariat Komisji Bioetycznej, Specialist inz. Iwona Siudalska; 61 Zwirki i Wigury St, Warsaw, 02-091, Poland Query! Ethics committee country [1] 318932 0 Poland Query! Date submitted for ethics approval [1] 318932 0 04/03/2014 Query! Approval date [1] 318932 0 15/04/2014 Query! Ethics approval number [1] 318932 0 Query!
Summary Brief summary Chronic low back pain has become very common, and it affects younger and younger adults, which is particularly concerning. The key factors behind chronic low back pain include progressive mechanization and computerization of modern life and non-compliance with ergonomics. The aim of our study was to determine the most effective method of conservative treatment to reduce pain in spinal osteoarthritis and degenerative disc disease in a lasting way. Based on experience and observation, patients with lower back pain who are treated with manual therapy achieve better therapeutic outcomes than those treated with physical therapy. To test this hypothesis, a study was conducted in which one group (Group A) received physical therapy, while the other group (Group B) received osteopathic manual therapy. Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 145718 0 Mr Kamil Slusarz Query! Address 145718 0 "Alfa-Lek Medical Center", 58A Nowy Swiat St, Warszawa, 00-363 Mazowieckie prvince, Poland Query! Country 145718 0 Poland Query! Phone 145718 0 +48 506033925 Query! Fax 145718 0 Query! Email 145718 0 [email protected] Query! Contact person for public queries Name 145719 0 Kamil Slusarz Query! Address 145719 0 "Alfa-Lek Medical Center", 58A Nowy Swiat St, Warszawa, 00-363 Mazowieckie prvince, Poland Query! Country 145719 0 Poland Query! Phone 145719 0 +48 506033925 Query! Fax 145719 0 Query! Email 145719 0 [email protected] Query! Contact person for scientific queries Name 145720 0 Kamil Slusarz Query! Address 145720 0 "Alfa-Lek Medical Center", 58A Nowy Swiat St, Warszawa, 00-363 Mazowieckie prvince, Poland Query! Country 145720 0 Poland Query! Phone 145720 0 +48 506033925 Query! Fax 145720 0 Query! Email 145720 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No
No IPD sharing reason/comment: The survey was anonymous. We didn't collect data of any of participant.

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