Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain

NCT05080374 | Completed DMC

• 1 other identifier: 3500/2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person will have low back pain during their life ( 3), lumbago produces 300,000 years lived with disability (ADL), being the first burden of disease in Chile, surpassing hypertensive heart disease and depression (4). There are many therapeutic approaches to the management of nonspecific low back pain, including high-speed, low-amplitude spinal manipulations (5). This technique consists of applying a short and rapid force at the level of the joint that is restricted, in order to restore normal joint mobility. The physiological effects of manipulations are not sufficiently studied, but some authors (6) (7) suggest that the nervous system is the mediator of the effects of spinal manipulation. Among non-pharmacological interventions, numerous clinical guidelines recommend the use of therapeutic exercise for low back pain (8), including a wide variety of types of recommended exercises, the most traditionally recommended being aerobic exercises, exercises that involve stretching postures of the back. vertebral musculature, strengthening and strength exercises (9) and central stabilization exercises (10). Recently, the effects of inspiratory muscle and diaphragm training exercises in patients with low back pain are being investigated (11). The application of an elastic bandage (12) in the lumbar area generates a proprioceptive signal through the skin, producing analgesia and a feeling of support in the area. Objectives: To compare the effects of different therapeutic approaches in combination with spinal manipulation. Design and method: Single-blind randomized clinical trial Results: Significant differences are expected before and after treatment and differences between groups. Conclusion: The aims of this study is to demonstrate that High speed and low amplitude spinal manipulation plus other conservative treatment is a valid therapeutic strategy for the management of nonspecific low back pain

Conditions

Back Pain; Lumbar Pain Syndrome; Back Pain, Low

Outcome Measures

Primary Outcomes (6)

• changes in pain EVA

  observe changes in pain through visual analogue scale (VAS) 0 to 10

  baseline after 6 weeks and a month

• Changes in pain pressure algometers

  observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)

  baseline after 6 weeks and a month

• Biomechanical changes (lateral tilt test)

  observe the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)

  baseline after 6 weeks and a month

• biomechanical changes (finger-floor test)

  observe the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)

  baseline after 6 weeks and a month

• Biomechanical changes (shober test)

  observe the changes in the biomechanics of the spine through the Shober test (Schöber test. It is performed with the patient standing and the examiner on his back. A point is indicated that locates L5 (at the height of the dimples of Venus or the iliac crests are used, which correspond to L4, and is marked 1cm below) and a second point is marked 10cm above.)

  baseline after 6 weeks and a month

• changes in function

  observe changes in disability due to nonspecific low back pain through the Oswestry test (The Oswestry Test comprises 10 items, of 10 points each, with a maximum of 100, this score being the worst possible functional state.)

  baseline after 6 weeks and a month

Study Arms (3)

HVLA + exercise Group

EXPERIMENTAL

Spinal manipulation (HVLA) + trunk exercise program

Other: Spinal Manipulation + exercise program

HVLA + kinesiotaping group

EXPERIMENTAL

Spinal manipulation (HVLA) + Kinesiotaping (lumbar)

Other: Spinal manipulation + Kinesiotaping

HVLA + Respiratory exercise group

EXPERIMENTAL

Spinal manipulation (HVLA) + respiratory exercise program

Other: spinal manipulation + respiratory exercise

Interventions

Spinal Manipulation + exercise program OTHER

high-speed, low-amplitude spinal manipulation plus a trunk exercise program

HVLA + exercise Group

Spinal manipulation + Kinesiotaping OTHER

high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area

HVLA + kinesiotaping group

spinal manipulation + respiratory exercise OTHER

high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles

HVLA + Respiratory exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years
• with nonspecific low back pain

You may not qualify if:

• chronic low back pain (more than 3 months)
• spinal surgeries
• red flags for spinal manipulation (osteoporosis, bone metastasis, etc)

Sponsors & Collaborators

• Ignacio Alejandro Astudillo Ganora: lead

Study Sites (1)

Physiotherapy deparment, Murcia University

Murcia, Spain

Location

MeSH Terms

Conditions

Back Pain; Somatoform Disorders; Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, Phd

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 15, 2021
• Study Start: August 11, 2021
• Primary Completion: September 11, 2021
• Study Completion: September 11, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)