Multidisciplinary programme for failed back surgery syndrome.

Multimodal exercises integrated with cognitive-behavioural therapy improve disability of subjects with failed back surgery syndrome: A randomized controlled trial with one-year follow-up.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21221956

Enrollment

135

Registered

2019-03-12

Start date

2012-01-01

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

Lumbar pain, with or without leg involvement, following lumbar surgery (failed back surgery syndrome). Musculoskeletal Diseases

Interventions

Experimental group. Multimodal and task-oriented exercises and cognitive-behavioural therapy. Control group. Passive spinal mobilisation, strengthening, muscle segmentary stretching, a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Presence of lumbar pain, with or without leg involvement, following lumbar surgery 2. Lumbar surgery occurred once or more, being within the first (if more interventions, in the last) postoperative year 3. Good understanding of Italian 4. Age of >18 years 5. Expert spinal surgeons confirmed the accuracy of their pre-op diagnoses and excluded new surgical indications for pain persistence, such as the presence of residual lumbar foraminal and/or central stenosis, residual painful disc, epidural fibrosis, improper screw placement, non-union or abnormal motion at a fusion level, before sending for conservative treatment.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment (MMSE<24) 2. Specific causes of LBP, such as deformity, infection, fracture or malignancy, unstable cardiovascular and pulmonary diseases, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging. 3. Previously received workers’ compensation 4. Previously received CBT

Design outcomes

Primary

Measure	Time frame
Disability was assessed using the validated Italian version of the self-reported 10-item Oswestry Disability Questionnaire (ODI) at baseline, 10-weeks and 12-months.	—

Secondary

Measure	Time frame
1. Kinesiophobia was assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia (TSK) at baseline, 10-weeks and 12-months. 2. Catastrophising was evaluated by means of the 13-item validated Italian version of the self-reported Pain Catastrophising Scale (PCS) at baseline, 10-weeks and 12-months. 3. Pain intensity was assessed using an 11-point numerical rating scale at baseline, 10-weeks and 12-months. 4. Quality of life was assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) at baseline, 10-weeks and 12-months. 5. Patient-rated efficacy of treatment using the Global Perceived Effect scale (GPE) at end of treatment.	—

Measure

Time frame

1. Kinesiophobia was assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia (TSK) at baseline, 10-weeks and 12-months. 2. Catastrophising was evaluated by means of the 13-item validated Italian version of the self-reported Pain Catastrophising Scale (PCS) at baseline, 10-weeks and 12-months. 3. Pain intensity was assessed using an 11-point numerical rating scale at baseline, 10-weeks and 12-months. 4. Quality of life was assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) at baseline, 10-weeks and 12-months. 5. Patient-rated efficacy of treatment using the Global Perceived Effect scale (GPE) at end of treatment.

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Countries

Italy

Outcome results

None listed

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