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NCT Number: NCT02312778

Immediate Effects of a Spinal Lumbar Manipulation

Non-specific low back pain is defined as a pain with no specific vertebral-related cause, such as infectious disease, tumor, osteoporosis, fracture, structural abnormality, inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific low back pain is a common disease in many countries. This musculoskeletal disorder is costly to public health systems. Therefore, the use of manual therapies is important in the treatment of this disease and studies show the effectiveness of this type of therapy.

Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There is moderate evidence that spinal manipulation is superior to sham spinal manipulation for improving short-term pain and function in chronic and acute non-specific low back pain. However the therapeutic mechanisms involved in this procedure are not well understood. Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be effective in reducing pain and improving functional capacity in subjects with non-specific low back pain, the effect on postural variables have not been investigated. Therefore, the aim of this study is to evaluate the acute effect of lumbar manipulation on pain and postural variables.

Twenty-four individuals with non-specific low back pain will be randomly allocated to two groups. The intervention group will receive high velocity and low amplitude spinal therapy, while the control group will receive sham manipulation. Immediately before and after the respective manipulation protocol, both groups will be evaluated regarding pain level, using a visual-analogue scale and algometer, and postural variables, using center of pressure displacement measured with the aid of a force plate. While the patient and therapist manipulator will be aware of the protocol applied in each case, the evaluator will be blind. A statistical treatment will be used to compare the results.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

About this study

Mean and standard deviation are calculated for each variable of postural control, as well as the values obtained in the measurement of pain using the numeric pain rating scale and algometry data.

t-test or Mann-Whitney test will be used to compare data before and after the manipulation protocol.

Multiple One-Way ANOVAs will be used to compare the manipulation protocol, for each dependent variable: effects of pain and center of pressure displacement.. Statistical analysis will be conducted with a confidence interval of 95%, α value of 5%, p value of ≤ 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • recurrent low back pain in the last three months;
  • medical diagnosis of non-specific low back pain, daily or almost daily;
  • subjects that will present at least four variables which encompass the clinical prediction rule: symptoms duration less than 16 days, Fear Avoidance-Beliefs Questionnaire score lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.

Exclusion criteria

  • subjects presenting symptoms that pass the knee;
  • impairment of neurologic signs like sensibility, muscle force and deep tendon reflex;
  • a prior history of spondylolisthesis, spinal stenosis, inflammatory disease, cancer, musculoskeletal degenerative disease, pregnancy, disease and drugs that impairment the balance;
  • subjects who received a HVLA manipulation of the lumbar spine at least three months earlier;
  • will be excluded women older than 50 years, that don't will present a bone mineral density exam.

Treatment and study plan

HVLA manipulation

Other

Intervention Group who receives a high velocity and low amplitude (HVLA) lumbar manipulation. A manual procedure also known as high velocity and low amplitude lumbar spinal manipulation are delivered for the subjects in the side lying position. The lumbar segment more restrict (mobility restriction) will be the target region for the manipulative procedure.

Primary outcomes

  1. pressure pain threshold assessment (algometer)

    Time frame: Within one day

    An algometer will used to assess the pressure pain threshold at baseline and following the intervention

Secondary outcomes

  1. Clinical Prediction Rule

    Time frame: Within one day

    Variables which encompass the clinical prediction rule: symptoms lower than 16 days, Fear Avoidance-Beliefs Questionnaire lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.

  2. Center of pressure displacement

    Time frame: Within one day

    A force platform will be used to measure the displacement of the center of pressure (COP) in the anterior-posterior direction at baseline and following the intervention

  3. Subjective pain assessment

    Time frame: Within one day

    Visual-analogue scale will be used to obtain a subjective assessment of pain at baseline and following the intervention

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

Immediate Effects of a Spinal Lumbar Manipulation on the Threshold Pressure Pain and the Postural Control in Subjects With Non-specific Low Back Pain

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
May 22, 2015

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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