Neuroscience Pain Education in Patients with Chronic Low Back Pain

October 9, 2024 updated by: Ismail Saracoglu, Kutahya Health Sciences University

The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients with Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kutahya, Turkey, 43000
        • Yoncali Physical Therapy and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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,

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuroscience pain education group
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
Other: neuroscience pain education
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.
Other: manual therapy
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.
Other: home exercises
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.
Experimental: Manual therapy group
in Group 2, participants received manual therapy and a home exercise program.
Other: manual therapy
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.
Other: home exercises
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.
Active Comparator: Control group
in Group 3, participants received home exercise program only.
Other: home exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale (NPRS)
Time Frame: Change from Baseline NPRS at 4th weeks and 12th weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Change from Baseline ODI at 4th weeks and 12th weeks
The participants' level of functioning was evaluated using the Turkish adaptation of the ODI. The scale comprises 10 items, each with 6 options worth 0 to 5 points. For each item, participants are asked to mark the option that best describes their current condition. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Change from Baseline ODI at 4th weeks and 12th weeks
Back Performance Scale (BPS)
Time Frame: Change from Baseline BPS at 4th weeks and 12th weeks
The BPS includes five tests of trunk mobility. Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points (18). High score indicates poor performance.
Change from Baseline BPS at 4th weeks and 12th weeks
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Change from Baseline TSK at 4th weeks and 12th weeks
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
Change from Baseline TSK at 4th weeks and 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KutahyaMSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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