Neuroscience Pain Education in Patients With Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886636
• Other study ID #: KutahyaMSU
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2019
• Source: Kutahya Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 1, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Manual Therapy
• Neuroscience Pain Education

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Yoncali Physical Therapy and Rehabilitation Hospital	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Medical Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oswestry Disability Index (ODI)	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
Secondary	Back Performance Scale (BPS)	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
Secondary	Tampa Scale for Kinesiophobia (TSK)	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