The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain

NCT03852667 | Completed

• 1 other identifier: EC/GK2017/1508
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of a secondary intervention program for low back pain in patients with recurrent low back pain. One third of the subject will receive no therapy, one third wil receive 2 sessions of pain neuroscience education (PNE) and one third will receive two sessions of PNE and 5 sessions of exercise therapy over 6 weeks.

Conditions

Low Back Pain, Recurrent

Keywords

low back pain; recurrent; non-specific; secondary prevention; pain neuroscience education; exercise therapy

Outcome Measures

Primary Outcomes (3)

• Quality of core movement control by use of the Luomajoki test battery

  A core movement control test battery is performed pre and post intervention, to assess a possible movement control dysfunction of the low back. This test battery consists out of six tests: waiters bow, dorsal tilt of pelvis actively in upright standing, one leg stance, sitting knee extension test, quadruped position, prone lying active knee flexion.

  6 weeks

• Quality of proprioception of the core by use of the lumbopelvic position-reposition test

  A lumbopelvic position-reposition test was performed pre and post intervention for measuring proprioceptive deficits in the core in the subjects. This repositioning test evaluates the participant's repositioning accuracy of the pelvis, low back and trunk after a dynamic task.

  6 weeks

• Quality of neuromuscular control by use of the lumbopelvic movement control test

  The neuromuscular control of the lumbar region is measured pre and post intervention. This test evaluates a repeated lumbopelvic movement on five categories; quality of the lumbopelvic motion, control of the adjacent areas, preference of motion direction, breathing, and the amount of good quality repetitions.

  6 weeks

Secondary Outcomes (6)

• Improvement of trunk strength by use of a hand held dynamometer

  6 weeks

• Psychosocial factor "Tampa scale of kinesiophobia"

  6 weeks

• Psychosocial factor "Pain catastrophizing scale"

  6 weeks

• Psychosocial factor "Pain disability index"

  6 weeks

• Psychosocial factor "Multidimensional pain inventory"

  6 weeks

Study Arms (3)

Control

NO INTERVENTION

No intervention between the two test sessions

Pain Neuroscience Education

ACTIVE COMPARATOR

Two sessions (30 min) of Pain Neuroscience Education

Behavioral: Pain Neuroscience Education

Pain neuroscience education - exercise

EXPERIMENTAL

2 sessions of PNE and 5 sessions of exercise therapy.

Behavioral: Pain Neuroscience Education; Other: Exercise therapy

Interventions

Pain Neuroscience Education BEHAVIORAL

The PNE intervention consisted of 2 sessions of 30 minutes. In the first session, the main goal is to explain the patient why pain is important and why people can't live without it. Besides it is explained why objective findings such as x-rays, MRI, CT scans, etc. often lack significant findings despite the pain that the patient experiences. This first session of pain education might help the patient understand that pain is necessarily a result from tissue damage. Furthermore, the session explains the right approach to conquer pain and to avoid going down in this vicious circle of low back pain. The second session of PNE, is a revision of the first session, continuing on what was unclear from the first session.

Pain Neuroscience Education; Pain neuroscience education - exercise

Exercise therapy OTHER

The exercise therapy varies form analytical exercises in the first sessions, to functional and sports related exercises near the following sessions. The first session focuses on the lumbar neuromuscular control of the patients: first a voluntary contraction of the Transversus Abdominis muscle, the Multifidus muscle and the pelvic floor muscles is learned. When the subject is able to maintain the combined contraction for 10 times, the exercises evolve to more complicated tasks. In the final stage, more functional and sport specific tasks will be exercised.

Pain neuroscience education - exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In remission during testing
• recurrent low back pain (RLBP) \>6months
• or more episodes in the past year
• Pain flare of ≥24 hours, characterized by an increase of ≥2 on an Numeric Rating Scale (NRS) scale and/or ≥5 on the Roland Morris Disability Questionnaire
• Followed by a pain-free episode of ≥1 month, characterized by a 0/10 on an NRS scale and/or \<2 on the Roland Morris Disability Questionnaire
• Non-specific RLBP (no cause for Low back pain (LBP); \>3y post discus herniation)
• year or more post-natal

You may not qualify if:

• Use of antidepressants or analgesics (except for NSAIDs or paracetamol), taken 2 weeks before the testing
• Neurologic, respiratory, circulatory, or severe orthopedic diseases
• Pregnancy
• Specific LBP causes
• A history of cognitive exercise therapy and/or specific motor control training
• current treatment or new therapies starting \<6 weeks before baseline assessment

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Vakgroep Revalidatiewetenschappen

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Low Back Pain; Recurrence

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Lieven Danneels, PhD

  University Ghet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The leading investigators, as well as the outcome assessors are masked and do not know to which arm the subjects are allocated to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomization schedule was extracted from the website www.sealedenvelope.com . The randomization was expected to have the same amount of one gender in each group. The control group was group A, the group that only received PNE was group B and the group who received PNE and exercise therapy was group C.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 25, 2019
• Study Start: September 29, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)