NCT03901365

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Last Updated

October 15, 2024

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

April 1, 2019

Last Update Submit

October 9, 2024

Conditions

Keywords

Manual TherapyNeuroscience pain educationQuality of lifeChronic low back pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    Change from Baseline NPRS at 4th weeks.

Study Arms (2)

Group 1

EXPERIMENTAL

Patient received manual therapy in addition neuroscience pain education sessions

Other: Neuroscience pain educationOther: Manual therapy

Group 2

ACTIVE COMPARATOR

Patient received manual therapy in addition tradition education sessions

Other: Traditional patient educationOther: Manual therapy

Interventions

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.

Group 1

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.

Group 2

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.

Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yoncali Physical Therapy and Rehabilitation Hospital

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

April 1, 2018

Primary Completion

June 30, 2018

Study Completion

November 30, 2018

Last Updated

October 15, 2024

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations