Neuroscience Pain Education in Patients With Chronic Low Back Pain

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT03886636
Collaborator
(none)
69
1
3
11
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: neuroscience pain education
  • Other: manual therapy
  • Other: home exercises
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients With Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Numeric pain rating scale (NPRS) [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.

Secondary Outcome Measures

  1. Oswestry Disability Index (ODI) [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.

  2. Back Performance Scale (BPS) [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.

  3. Tampa Scale for Kinesiophobia (TSK) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yoncali Physical Therapy and Rehabilitation Hospital Kutahya Turkey 43000

Sponsors and Collaborators

  • Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ismail Saracoglu, Principle Investigator, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT03886636
Other Study ID Numbers:
  • KutahyaMSU
First Posted:
Mar 22, 2019
Last Update Posted:
Mar 22, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2019