Integral Versus Local Movement Therapy Approach in Patients With Idiopathic Chronic Low Back Pain

NCT03623802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-09

No results posted yet for this study

Summary

Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials to date included mostly trunk strengthening exercises (e.g. bird dog, plank) and there is no evidence about supervised, individually graded integral movement therapy program for patients with chronic low back pain (CLBP).

The research design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy. Participants in each group will receive 20 supervised sessions in a 10 week period, two times per week, with approximately 1 hour per session. Outcome assessments will occur at baseline and immediately post-intervention, follow up will take place at 6 months and 12 months after finishing the intervention. Pre specified analyses will evaluate the main effects of the treatment.

This trial will use a novel, previously unexplored integral approach to CLBP through exercises. In contrast to commonly used exercise programs, the integral program does not include specific local strength exercises for hip and trunk flexors and extensors. However, learning dynamic trunk muscle control in various body positions with added limb movements could be beneficial because of the parallels to everyday work. The study will contribute to clinical practice by providing evidence to guide professionals when deciding for the proper and efficient treatment of patients with CLBP.

Conditions

  • Low Back Pain

Interventions

OTHER

Local Movement Therapy

Loads and intensity of exercises will be increased according to participants' abilities. Modifications of exercises are made through different body positions or increasing the load. When a participant will be able to perform a certain number of repetitions and sets of a required exercise, without any compensatory movements, he/she can proceed to the next level of exercise. Breaks between exercises and sets are the same as in the integral movement therapy protocol. Protocol consists of four basic exercises, which are progressed through sessions: (I) Abdomen curl. (II) Trunk extension on roman chair. (III) Hip bridge. (IV) Side plank.

OTHER

Integral Movement Therapy

Protocol consists of four basic exercises, which are progressed through sessions: (I) Proprioception - sitting on an unstable surface - Swiss ball, with additional tasks with legs and arms. (II) Strength - pushing task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (III) Strength - pulling task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (IV) Lifting and carrying the loads: a) Stoop lifting. b) Squat lifting. c) Half kneeling lifting.

Sponsors & Collaborators

  • University of Primorska

    lead OTHER

Principal Investigators

  • Nejc Šarabon, PhD · Faculty of Health Sciences, University of Primorska, Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-12-31
Completion
2019-01-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623802 on ClinicalTrials.gov