Improving Patient Choice in Treating Low Back Pain

Improving Patient Choice in Treating Low Back Pain: a cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46035546

Enrollment

158

Registered

2010-02-11

Start date

2010-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back pain Musculoskeletal Diseases Dorsalgia

Interventions

Curent interventions as of 21/02/2013: Physiotherapists will be randomised to intervention or control. Those in the intervention arm will be trained on informed shared decision making which they will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients seeking treatment for non specific low back pain 2. Aged greater than or equal to 18 years, either sex 3. Fluent spoken and written English

Exclusion criteria

Exclusion criteria: 1. Severe psychiatric or personality disorders 2. Terminal illness 3. Critical illness 4. Possible serious spinal pathology including tumour, sepsis or fracture

Design outcomes

Primary

Measure	Time frame
Satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied)	—

Secondary

Measure	Time frame
Measured at baseline and 3 months: 1. Roland Morris Disability Questionnaire (RMDQ) - the leading measure of LBP-related disability in primary care trials 2. Modified Von Korff - a measure of LBP and disability over the preceding month 3. 12-item short form health survey (SF-12) - a generic measure of health-related quality of life 4. EuroQol - a generic measure of health utility that is designed for use in RCTs 5. Hospital Anxiety and Depression Scale (HADS) - an established and validated self rating instrument for anxiety and depression 6. Pain Self-Efficacy Questionnaire (PSEQ) - an established measure self-efficacy for people with chronic pain 7. Fear Avoidance Beliefs Questionnaire (FABQ) - the physical sub-scale of FABQ measures attitude to movement in back pain 8. A question on change in ability to perform daily tasks 9. A question on change in low back pain since beginning treatment 10. Compliance - we will measure compliance from the physiotherapy department?s attendance records. We will also collect data from participants on health service use and health transition 11. Immediate follow-up assessment will focus on satisfaction with the decision making process. We will use the 'Satisfaction with Decision Scale' to measure satisfaction with the health care decision.	—

Measure

Time frame

Measured at baseline and 3 months: 1. Roland Morris Disability Questionnaire (RMDQ) - the leading measure of LBP-related disability in primary care trials 2. Modified Von Korff - a measure of LBP and disability over the preceding month 3. 12-item short form health survey (SF-12) - a generic measure of health-related quality of life 4. EuroQol - a generic measure of health utility that is designed for use in RCTs 5. Hospital Anxiety and Depression Scale (HADS) - an established and validated self rating instrument for anxiety and depression 6. Pain Self-Efficacy Questionnaire (PSEQ) - an established measure self-efficacy for people with chronic pain 7. Fear Avoidance Beliefs Questionnaire (FABQ) - the physical sub-scale of FABQ measures attitude to movement in back pain 8. A question on change in ability to perform daily tasks 9. A question on change in low back pain since beginning treatment 10. Compliance - we will measure compliance from the physiotherapy department?s attendance records. We will also collect data from participants on health service use and health transition 11. Immediate follow-up assessment will focus on satisfaction with the decision making process. We will use the 'Satisfaction with Decision Scale' to measure satisfaction with the health care decision.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026