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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901365
Other study ID # KutahyaMSUFTR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date November 30, 2018

Study information

Verified date March 2021
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 30, 2018
Est. primary completion date June 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 Exclusion Criteria: - Previous spine or lower extremity surgery - Severe osteoporosis - Spondyloarthropathy - Spondylolisthesis - Lumbar stenosis - Lumbar fractures - Malign tumor

Study Design


Intervention

Other:
Neuroscience pain education
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
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
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire 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 Change from Baseline SF-36 at 4th weeks.
Secondary 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.
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