Low back pain education and quality of life: a randomized trial
| ISRCTN | ISRCTN48558333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48558333 |
| Protocol serial number | N/A |
| Sponsor | Iranian Institute for Health Sciences Research (Iran) |
| Funder | Iranian Institute for Health Sciences Research (Iran) |
- Submission date
- 20/06/2006
- Registration date
- 26/07/2006
- Last edited
- 05/03/2007
- 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
Dr Ali Montazeri
Scientific
Scientific
P.O. Box 13185-1488
Tehran
-
Iran
| Phone | +98 (0) 21 6409786 |
|---|---|
| ali@jdcord.jd.ac.ir |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Low back education programme could improve quality of life in patients with low back pain. |
| Ethics approval(s) | Ethics approval received from Tehran University of Medical Sciences Ethics Committee in March 2003. |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | Back School Programme: the back school programme is a four-day, five-session, multidimensional and interdisciplinary educational regime designed to assess each patients physical condition, personal characteristics, lifestyle and subsequent ability to cope. Group 1: patients received medication and education with the back school programme. Group 2: patients received the medication alone. |
| Intervention type | Other |
| Primary outcome measure(s) |
The principal outcome measure was quality of life. The mean increase in quality of life score above the baseline was used as the main outcome measure of the patients responses to the intervention. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 102 |
| Key inclusion criteria | 1. Women age 18 years and over 2. Suffering from chronic back pain (persisting for 90 days or more) 3. Having a telephone number for regular contact with a responsible caregiver |
| Key exclusion criteria | 1. Patients who had back surgery two years prior to the initial observation 2. If the complaint was restricted to the sacroiliac joint or the cervical or thoracic regions 3. Patients with congenital spine disease 4. Patients with a low back complaint that had persisted less than 90 days |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- Iran
Study participating centre
P.O. Box 13185-1488
Tehran
-
Iran
-
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 28/02/2007 | Yes | No |
