Neuroscience Pain Education in Patients with Chronic Low Back Pain

NCT03886636 | Completed

• 1 other identifier: KutahyaMSU
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.

Conditions

Chronic Low Back Pain; Manual Therapy; Neuroscience Pain Education

Outcome Measures

Primary Outcomes (1)

• Numeric pain rating scale (NPRS)

  The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.

  Change from Baseline NPRS at 4th weeks and 12th weeks

Secondary Outcomes (3)

• Oswestry Disability Index (ODI)

  Change from Baseline ODI at 4th weeks and 12th weeks

• Back Performance Scale (BPS)

  Change from Baseline BPS at 4th weeks and 12th weeks

• Tampa Scale for Kinesiophobia (TSK)

  Change from Baseline TSK at 4th weeks and 12th weeks

Study Arms (3)

Neuroscience pain education group

EXPERIMENTAL

in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.

Other: neuroscience pain education; Other: manual therapy; Other: home exercises

Manual therapy group

EXPERIMENTAL

in Group 2, participants received manual therapy and a home exercise program.

Other: manual therapy; Other: home exercises

Control group

ACTIVE COMPARATOR

in Group 3, participants received home exercise program only.

Other: home exercises

Interventions

neuroscience pain education OTHER

A total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.

Neuroscience pain education group

manual therapy OTHER

In our study, 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.

Manual therapy group; Neuroscience pain education group

home exercises OTHER

All participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks.

Control group; Manual therapy group; Neuroscience pain education 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:

• 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
• Used pregabalin and gabapentin derivatives,

You may not qualify if:

• Previous spine or lower extremity surgery
• Severe osteoporosis
• Spondyloarthropathy
• Spondylolisthesis
• Lumbar stenosis
• Systemic inflammatory diseases

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Yoncali Physical Therapy and Rehabilitation Hospital

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

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: Principle Investigator

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: February 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: January 1, 2019
• Last Updated: October 15, 2024

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)