Immediate Effects of a Spinal Lumbar Manipulation

NCT02312778 | Completed

• 1 other identifier: AVBA x COP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

non-specific low back pain; center of pressure; spinal lumbar manipulation; high velocity and low amplitude manipulation; postural control

Outcome Measures

Primary Outcomes (1)

• pressure pain threshold assessment (algometer)

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

  Within one day

Secondary Outcomes (3)

• Clinical Prediction Rule

  Within one day

• Center of pressure displacement

  Within one day

• Subjective pain assessment

  Within one day

Study Arms (2)

HVLA Manipulation

EXPERIMENTAL

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 is delivered to the subjects in the side lying position. The more restricted lumbar segment (mobility restriction) will be the target region for the manipulative procedure.

Other: HVLA Manipulation

Sham Manipulation

NO INTERVENTION

Control Group who receives a simulated manipulation.

Interventions

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.

HVLA Manipulation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul

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

Location

Related Publications (1)

• Fagundes Loss J, de Souza da Silva L, Ferreira Miranda I, Groisman S, Santiago Wagner Neto E, Souza C, Tarrago Candotti C. Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial. Chiropr Man Therap. 2020 Jun 3;28(1):25. doi: 10.1186/s12998-020-00316-7.

  PMID: 32487243 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

• Jefferson F Loss, Phd

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 9, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

BR (1)