Clinical trial NCT05974072: A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
Official title: A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: chronic pain
pain catastrophizing
therapeutic patient education
therapeutic exercise
mindfulness
cognitive behavioural therapy
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present feasibility study aims to evaluate the feasibility and adequacy of a multidisciplinary treatment program as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona. Secondarily, the present study will also evaluate the effect on pain-related outcomes to estimate the number of needed participants for a full trial.

The main questions it aims to answer are:

* Is the proposed multidisciplinary treatment feasible and adequate for chronic low back pain patients?
* Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?

Participants will receive either usual care (pharmacological control) or eight multidisciplinary sessions within two months, composed of therapeutic patient education, mindfulness relaxation, cognitive-behavioural therapy and therapeutic exercise. Besides, participants will be assessed using written questionnaires before and after treatment and two months after treatment.

Researchers will assess the feasibility of the multidisciplinary treatment group and will compare both groups to see if there is any difference in several pain-related outcomes.

Detailed description: Despite improving pharmacological and surgical medical treatment options, long-lasting low back pain is the most frequent pain disorder and a leading cause of disability. Over the past decades, clinicians have acknowledged that a broader view of disease and disability is needed in chronic conditions treatment. Therefore, biological, psychological and social factors must be addressed to improve such conditions.

The present study aims to evaluate the viability and adequacy of a multidisciplinary treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain intensity, the improvement of pain-related disability, the improvement of quality of life, and the reduction of pain catastrophizing.

Eligibility criteria: Inclusion Criteria:

* Patients with primary chronic low back pain (non-specific chronic low back pain).
* Predominantly axial pain, for at least 50% of the time during the last 6 months.
* Average pain intensity equal or greater than 4 out of 10 on a verbal numerical scale, during the present week.
* Predisposed to receive an active, non-pharmacological and non-surgical treatment.

Exclusion Criteria:

* Inflammatory low back pain.
* History of cancer in the past 5 years.
* Unexplained and involuntary weight loss of 10 Kg during the last year.
* Problems in the control of bowel and bladder function.
* Difficulty attending sessions due to severe physical disability.
* Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
* Addiction disorder to parenteral drugs or strong prescription opioids. Technical-logistical problems (inability to attend treatment sessions, inability to complete evaluation questionnaires).
* Seeking compensation or litigation in the last year.
* Severe hearing loss or severe cognitive impairment.

Primary outcomes:
measure: Recruitment rate
timeFrame: 4 months prior to study start
measure: Number of participants completing treatment
timeFrame: 2 months
measure: Follow-up rate
timeFrame: 4 months
measure: Acceptance of treatment and detection of barriers
timeFrame: 2 months
Secondary outcomes:
measure: Pain Intensity. Changes from baseline to 2 months after treatment.
timeFrame: Baseline, 2 months, 4 months
measure: Pain-related disability. Changes from baseline to 2 months after treatment.
timeFrame: Baseline, 2 months, 4 months
measure: Health-related quality of life. Changes from baseline to 2 months after treatment.
timeFrame: Baseline, 2 months, 4 months
measure: Pain Catastrophizing. Changes from baseline to 2 months after treatment.
timeFrame: Baseline, 2 months, 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalonia
Study officials:
References:
citation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
citation: Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.
citation: Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.