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NCT Number: NCT03420196

Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain

This study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almería

Almería, Andalusia, 04120, Spain

About this study

Low back pain is one of the most common problems of population, being a priority for health systems. It has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program.

Objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain.

Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, McQuade Test, and lumbar mobility flexion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic non-specific low back pain persisting ≥ 3 months.
  • Age between 18 and 65 years.
  • A score ≥ 4 in Roland Morris Disability Questionnaire.
  • Not currently receiving physical therapy.

Exclusion criteria

  • Presence of lumbar stenosis.
  • Presence of clinical signs of radiculopathy.
  • Diagnosis of spondylolisthesis.
  • Diagnosis of fibromyalgia.
  • Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
  • A history of spinal surgery.
  • Central or peripheral nervous system disease.

Treatment and study plan

Supervised exercise program

Other

It will consist in a supervised exercise program, including the following exercises:

  • Diaphragmatic breathing.
  • Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
  • Pelvic swing.
  • Gluteus bridge.
  • Spinal mobility.
  • Spinal extensor muscles strengthening
  • Frontal plank
  • Side plank.
  • Lateral leg raise for gluteus medium

Non supervised exercise program

Other

It will consist in a non supervised exercise program, including the following exercises:

  • Diaphragmatic breathing.
  • Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
  • Pelvic swing.
  • Gluteus bridge.
  • Spinal mobility.
  • Spinal extensor muscles strengthening
  • Frontal plank
  • Side plank.
  • Lateral leg raise for gluteus medium

Primary outcomes

  1. Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

    Time frame: at baseline,immediate post-treatment and at 6 months

    This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities

Secondary outcomes

  1. Change from baseline in disability. Oswestry Low Back Pain Disability Index.

    Time frame: At baseline, immediate post-treatment and at 6 months

    It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points

  2. Change from baseline in pain intensity (Visual Analogue Scale).

    Time frame: At baseline, immediate post-treatment and at 6 months

    A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain

  3. Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

    Time frame: At baseline, immediate post-treatment and at 6 months

    It is a 17-item questionnaire that measures the fear of movement and (re)injury

  4. Change from baseline on Quality of Life.

    Time frame: At baseline, immediate post-treatment and at 6 months

    SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

  5. Change from Mcquade Test

    Time frame: at baseline, immediate post-treatment and at 6 months

    It measures the isometric endurance of trunk flexion muscles

  6. Change from baseline in lumbar mobility flexion

    Time frame: at baseline, immediate post-treatment and at 6 months

    It is determined by measuring the finger-to-floor distance.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised on Pain, Disability, Quality of Life and Kinesiophobia in Patients With Non-specific Low Back Pain

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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