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

NCT03623802 | Unknown

• 1 other identifier: LBPStudy-0120-93/2018/6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic low back pain; Movement therapy; Supervised training

Outcome Measures

Primary Outcomes (3)

• CHANGE IN INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (IPAQ) SCORE

  The International Physical Activity Questionnaire (IPAQ) is developed to measure health-related physical activity (PA) in populations.

  1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.

• Change in Oswestry Low Back Disability Questionnaire (ODI) Score

  Oswestry Low Back Disability Questionnaire is used to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.

  1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.

• Change inn Numeric Rating Scale for Pain (NRS) Score

  The NRS for pain is a unidimensional measure of pain intensity in adults.

  1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.

Secondary Outcomes (10)

• Change in Timed-up-and-go test (TUG) score

  1 week before the first therapy and after 11 weeks of therapy.

• Change in Sit-to-stand test score

  1 week before the first therapy and after 11 weeks of therapy.

• Change in Chair sit-and-reach test score

  1 week before the first therapy and after 11 weeks of therapy.

• Change in 6 minute walk test score

  1 week before the first therapy and after 11 weeks of therapy.

• Change in Spine flexibility.

  1 week before the first therapy and after 11 weeks of therapy.

Study Arms (2)

Local Movement Therapy

EXPERIMENTAL

Group receiving treatment in form of Local Movement Therapy Program.

Other: Local Movement Therapy

Integral Movement Therapy

EXPERIMENTAL

Group receiving treatment in form of Integral Movement Therapy Program.

Other: Integral Movement Therapy

Interventions

Local Movement Therapy OTHER

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.

Local Movement Therapy

Integral Movement Therapy OTHER

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.

Integral Movement Therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic idiopathic low back pain which persists at least 12 weeks or two acute low back pain episodes in the last 12 months.
• Patients aged between 30 and 60 years.
• Capable of at least low physical activity to be able to complete movement therapy program.

You may not qualify if:

• Severe spinal stenosis, spondylolisthesis, fibromyalgia.
• Lumbar spine surgery.
• Vascular disease.
• Neurological deficits because of nerve root or spinal cord compression.
• Ongoing treatment for low back pain.
• Pregnancy.
• Comorbid health conditions that could prevent active participation in exercise.

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

Health Center Kranj

Kranj, 4000, Slovenia

RECRUITING

Related Publications (1)

• Pustivsek S, Sarabon N. Integral movement therapy versus local movement therapy approach in patients with idiopathic chronic low-back pain: study protocol for a randomized controlled trial. Trials. 2019 Jan 21;20(1):69. doi: 10.1186/s13063-018-3128-z.

  PMID: 30665438 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nejc Šarabon, PhD

  Faculty of Health Sciences, University of Primorska, Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nejc Šarabon, PhD

CONTACT

+386 40 429 505; nejc.sarabon@fvz.upr.si

Suzana Pustivšek, PhD

CONTACT

suza.pustivsek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Sc.

Model Details: The study design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy.

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 9, 2018
• Study Start: May 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

SL (1)