Early management of psychological factors for subjects with sub-acute low back pain.

Early management of psychological factors reduce disability of subjects with sub-acute low back pain. Results of a randomized controlled study with one year follow-up.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55789697

Enrollment

135

Registered

2019-06-26

Start date

2013-01-01

Completion date

Unknown

Last updated

2020-06-22

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

Conditions

Subacute low back pain Musculoskeletal Diseases

Interventions

Experimental group. Task-oriented exercises and cognitive-behavioural therapy aimed at modifying wrong beliefs and behaviours concerning subacute pain. Control group. exercises for pas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Sub-acute (i.e., a documented history of pain lasting from 4 weeks to up to 12 weeks) non-specific low back pain attending our rehabilitation hospital 2. Good understanding of Italian 3. Age < 18 years

Exclusion criteria

Exclusion criteria: 1. Acute (lasting up to 4 weeks) and chronic LBP (lasting > twelve weeks) 2. Cognitive impairment (MMSE<24) 3. All causes of specific LBP, such as previous spinal surgery, deformity, infection, fracture or malignancy, unstable cardiovascular and pulmonary diseases, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging 4. Previously received cognitive-behavioural therapy

Design outcomes

Primary

Measure	Time frame
Disability assessed using the validated Italian version of the self-reported 10-item Oswestry Disability Questionnaire (ODI) before interventions, 10 weeks later (post-training), and 12 months (12M follow-up) after the end of treatment	—

Secondary

Measure	Time frame
Before interventions, 10 weeks later (post-training), and 12 months (12M follow-up) after the end of treatment 1. Pain intensity assessed using an 11-point numerical rating scale 2. Kinesiophobia assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia (TSK) 3. Unhelpful beliefs assessed by the 16-item questionnaire Pain Beliefs and Perceptions Inventory (PBAPI) 4. Anxiety and depression investigated by the Hospital Anxiety and Depression Score (HADS) 5. Strategies for coping pain were evaluated by the Coping Strategies Questionnaire-revised (CSQ-R) 6. Quality of Life assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) 7. Return to work 8. Sick leave days 9. Patient-rated efficacy of treatment using the Global Perceived Effect scale (GPE)	—

Measure

Time frame

Before interventions, 10 weeks later (post-training), and 12 months (12M follow-up) after the end of treatment 1. Pain intensity assessed using an 11-point numerical rating scale 2. Kinesiophobia assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia (TSK) 3. Unhelpful beliefs assessed by the 16-item questionnaire Pain Beliefs and Perceptions Inventory (PBAPI) 4. Anxiety and depression investigated by the Hospital Anxiety and Depression Score (HADS) 5. Strategies for coping pain were evaluated by the Coping Strategies Questionnaire-revised (CSQ-R) 6. Quality of Life assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) 7. Return to work 8. Sick leave days 9. Patient-rated efficacy of treatment using the Global Perceived Effect scale (GPE)

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026