Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain

NCT03964389 | Completed

• 1 other identifier: 19/ 317
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Pain Neuroscience Education (PNE)). The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used.

Conditions

Back Pain Lower Back Chronic

Keywords

Central Nervous System Sensitization; kinesiophobia

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  6 weeks following the reported onset of symptoms.

Secondary Outcomes (3)

• Pain Catastrophizing: Pain Catastrophizing Scale

  baseline, 5 weeks and 12 weeks

• Kinesiophobia: Tampa Scale for Kinesiophobia (TSK 11)

  baseline, 5 weeks and 12 weeks

• - Central sensitisation inventory (CSI)

  baseline, 5 weeks and 12 weeks

Study Arms (2)

Intervetion group

EXPERIMENTAL

A sessions of "Pain Neuroscience Education (PNE)" joint a physical exercises programs

Other: Pain Neuroscience Education" (PNE)

Control group

NO INTERVENTION

Only a therapeutic physical exercises programs

Interventions

Pain Neuroscience Education" (PNE) OTHER

A lecture on neuroscience education (EN). The aim of this intervention is to provide participants with information in a clear and simple way so that patients can change their attitude to pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without tissue damage or with damage that justifies the perceived disproportion of pain.

Also known as: Therapeutic Neuroscience Education (TNE)

Intervetion group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients participating in the "back protocol" groups in the hospital
• That present pain of more than 3 months of evolution

You may not qualify if:

• Oncological pain
• Fracture or spinal surgery in the last year
• Cognitive neurological alteration that prevents understanding the contents of the session
• Alterations at the motor level that prevent the realization of the program of directed physical exercise that is currently carried out
• Pregnancy
• Urinary or intestinal incontinence
• Other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome)

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Hospital Universitario San Juan de Alicante: collaborator

Study Sites (1)

Hospital Universitario de San Juande Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (3)

• Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

  PMID: 27351541 BACKGROUND

• Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

  PMID: 22133255 BACKGROUND

• Traeger AC, Lee H, Hubscher M, Skinner IW, Moseley GL, Nicholas MK, Henschke N, Refshauge KM, Blyth FM, Main CJ, Hush JM, Lo S, McAuley JH. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.

  PMID: 30398542 BACKGROUND

Related Links

• Learn a science based approach to overcome chronic pain.
• An international research group that focuses on pain an dody movement

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants receive TEN sessions, but do not know that one of the groups will receive extra information
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two-armed randomized trial

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 28, 2019
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)