Naprapathy or evidence-based care provided by a physician for patients with non-specific low back and/or neck/shoulder pain: a randomised controlled trial
| ISRCTN | ISRCTN56954776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56954776 |
| Protocol serial number | N/A |
| Sponsor | Karolinska Institutet (Sweden) |
| Funders | Swedish Research Council (Sweden) (ref: K2005-27VK-15355-01A), Stockholm County Council (Sweden) (ref: 20050585), Uppsala County Council (Sweden), Capio (Sweden) (ref: 626), Swedish Naprapathic Association (Sweden) |
- Submission date
- 12/09/2006
- Registration date
- 30/10/2006
- Last edited
- 18/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Lars Alfredsson
Scientific
Scientific
Karolinska Instituet
Institute of Environmental Medicine
Box 210
Stockholm
SE-171 77
Sweden
| lars.alfredsson@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Naprapathy or evidence-based care provided by a physician for patients with non-specific low back and/or neck/shoulder pain: a randomised controlled trial |
| Study acronym | The BJÖRN-study |
| Study objectives | The hypothesis tested was: naprapathic treatment is more effective for patients with non-specific pain and disability in low back and/or neck/shoulder, than evidence-based advices provided by a physician. |
| Ethics approval(s) | Ethics committee approval was received on the 29th of December 2003 from the Karolinska Institutet (dnr: 03-657) |
| Health condition(s) or problem(s) studied | Neck, shoulder or low back pain |
| Intervention | Naprapathy (index group): One out of eight naprapaths gave a maximum of six treatments within six weeks in his/her own clinic. The naprapath decided how the treatment sequences should be performed and precise notes about the treatment, advises, progress and possible adverse reactions, were kept. Each appointment lasted for about 45 minutes. Naprapathy, founded by Dr Oakley Smith in the beginning of the 20th century, is a manual therapy for soft tissues and joints aimed at decreasing pain and re-establishing musculoskeletal function. Treatment with Naprapathy means that every patient is given an individual combination of manual naprapathic techniques as manipulation and mobilisation of joints as well as stretching and massage for the muscles. In addition to the manual treatments, preventive and rehabilitating physical activity and ergonomic advices often are given. Evidence Based Care provided by a physician (control group): One out of four physicians gave evidence based care in direct conjunction with the physical examination all participating patients got prior to the randomisation (an additional 15 minutes). The evidence-based care (gold standard) involved evidence-based advice and support by the physician according to guidelines that aimed to empower the patient in the understanding of the fact that the best prognosis for recovery is received by living as normal a life as possible, including work and physical activities. The aim of the consultation was empowerment of the patients belief in and faith in his/her own capacity to handle and cope with the pain. A booklet and exercises conformed to the patients conditions were given. Precise notes were kept and a second consultation (approximately 15 minutes) after three weeks was scheduled. The patient was told that additional consultation could be offered if necessary. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain and disability, measured by the Chronic Pain Questionnaire (CPQ) |
| Key secondary outcome measure(s) |
Health status, , measured by the Medical Outcomes Study Short Form-36 Health Survey (SF-36) at 26 and 52 weeks, incorporating |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 400 |
| Total final enrolment | 409 |
| Key inclusion criteria | Participants were assembled mainly among employees at two big companies in Stockholm, Sweden (in total around 40,000 persons) during the period March to September 2005. The inclusion criteria was a present non-specific pain in back or neck/shoulder of the kind that brought about marked disability at work and/or in leisure time, for at least two weeks. |
| Key exclusion criteria | 1. Pregnancy 2. Specific diagnose as acute slipped disc or spinal stenos 3. Recently have been exposed to naprapathic treatment or evidence based physician consultation (the preceding two months) or other manual therapy with the exception of massage (the preceding month) 4. Surgery in the painful area 5. Red flags (e.g. serious disease in back or neck and recent trauma in the area) 6. Not able to understand Swedish |
| Date of first enrolment | 07/03/2005 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karolinska Instituet
Stockholm
SE-171 77
Sweden
SE-171 77
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2007 | Yes | No | |
| Results article | results | 05/02/2010 | Yes | No | |
| Results article | 08/10/2021 | 11/10/2021 | Yes | No | |
| Results article | 16/05/2022 | 18/05/2022 | Yes | No |
Editorial Notes
18/05/2022: Publication reference and total final enrolment added.
11/10/2021: Publication reference added.
