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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 hypothesis | 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) |
| Condition | 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 | Pain and disability, measured by the Chronic Pain Questionnaire (CPQ) |
| Secondary outcome measures | Health status, , measured by the Medical Outcomes Study Short Form-36 Health Survey (SF-36) at 26 and 52 weeks, incorporating 1. Recovery 2. Quality of life 3. General health 4. Sick leave 5. Economical aspects in short and long term |
| Overall study start date | 07/03/2005 |
| Overall study end date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 409 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 07/03/2005 |
| Recruitment end date | 30/09/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karolinska Instituet
Stockholm
SE-171 77
Sweden
SE-171 77
Sweden
Sponsor information
Karolinska Institutet (Sweden)
University/education
University/education
Nobels väg 5
Solna
Stockholm
SE-171 77
Sweden
| Phone | +46 8 524 800 00 |
|---|---|
| info@ki.se | |
| Website | http://www.ki.se |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Government
Swedish Research Council (Sweden) (ref: K2005-27VK-15355-01A)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Stockholm County Council (Sweden) (ref: 20050585)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
Uppsala County Council (Sweden)
No information available
Capio (Sweden) (ref: 626)
No information available
Swedish Naprapathic Association (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
