The Effect of Neuroscience Pain Education on Quality of Life in Patients with Chronic Low Back Pain
The Effect of Neuroplastic Pain Education on Quality of Life in Patients with Chronic Low Back Pain Who Treated Via Manual Therapy: a Single Blind Randomized Controlled Study
1 other identifier
interventional
35
1 country
1
Brief Summary
Manual therapy are among the therapeutic approaches frequently used in chronic low back pain (CLBP). Although most clinicians conduct patient education according biomedical model of pain, a relatively new approach which is referred to as neuroscience pain education (NPE) is promising in patients with CLBP. Therefore the aim of this study was to investigate whether NPE in patients with CLBP who treated via manual therapy technique will produce different outcomes in terms of pain severity and QoL compared to traditional patient education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedOctober 15, 2024
March 1, 2021
3 months
April 1, 2019
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire
All patients additionally completed Turkish Short form-36 (SF-36) questionnaire, 36-item generic self-administered instrument that consists of eight subscales relating to various aspects of the QoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. The eight subscales are scored from 0 to 100, with higher scores indicating better health status
Change from Baseline SF-36 at 4th weeks.
Secondary Outcomes (1)
Numeric Pain Rating Scale (NPRS)
Change from Baseline NPRS at 4th weeks.
Study Arms (2)
Group 1
EXPERIMENTALPatient received manual therapy in addition neuroscience pain education sessions
Group 2
ACTIVE COMPARATORPatient received manual therapy in addition tradition education sessions
Interventions
In Neuroscience pain education (NPE) sessions, patients were informed about the pain experience and the neurophysiological process about pain. NPE was performed by the method proposed by Louw et al (12). NPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
In traditional patient education (TPE) sessions were aimed to explain to patients a proposed treatment or efficacy of a certain manual therapy technique or approach, have focused heavily on biomechanical and anatomical models. These models would imply that injury, disease, and muscle guarding may lead to altered movement patterns, asymmetrical loading, and resultant pain and dysfunction. TPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
Eligibility Criteria
You may qualify if:
- Volunteered to participate in the study.
- Patients with 18-65 years
- Had low back pain for at least 6 months,
- Reported pain severity of 5 or greater according to the numeric pain rating scale
You may not qualify if:
- Previous spine or lower extremity surgery
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar stenosis
- Lumbar fractures
- Malign tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yoncali Physical Therapy and Rehabilitation Hospital
Kütahya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator,
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
April 1, 2018
Primary Completion
June 30, 2018
Study Completion
November 30, 2018
Last Updated
October 15, 2024
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share