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Completed

NCT Number: NCT03901365

The Effect of Neuroscience Pain Education on Quality of Life in Patients with Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yoncali Physical Therapy and Rehabilitation Hospital

Kütahya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Previous spine or lower extremity surgery
  • Severe osteoporosis
  • Spondyloarthropathy
  • Spondylolisthesis
  • Lumbar stenosis
  • Lumbar fractures
  • Malign tumor

Treatment and study plan

neuroscience pain education

Other

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.

Traditional patient education

Other

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

Other

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.

Primary outcomes

  1. Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire

    Time frame: Change from Baseline SF-36 at 4th weeks.

    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

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Change from Baseline NPRS at 4th 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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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