Comparing the Effect of Chiropractic Manipulation and Spinal Decompression Device Treatment

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Other: Spinal Decompression Device Treatment; Other: Chiropractic Manipulation

• Registration Number: NCT05460286
• Lead Sponsor: Mustafa AĞRAŞ

Brief Summary

This study is aimed to compare the effects of chiropractic spinal manipulative therapy and spinal decompression device treatment on lower extremity muscle strength, balance performance, lumbar range of motion and mobility, functional status, pain, and quality of life in patients with chronic low back pain.

After the approval of the ethics committee, the research was carried out in the physical therapy and rehabilitation clinic of Medipol Mega University Hospital. Individuals between the ages of 18-60, who had complaints of low back pain for the last three months and who voluntarily agreed to participate in the study were included in the study. 40 participants with low back pain existing more than 3 months were randomized into one of two groups as Chiropractic Spinal Manipulative Therapy (CSMT) and Spinal Decompression (SD). Lumbar region chiropractic HVLA (High Velocity, Low Amplitude) spinal manipulation and/or sacroiliac joint chiropractic HVLA manipulation was applied to CSMT group, and lumbar region spinal decompression (traction) device therapy was applied to SD group, and as a standard of treatment was given a hot pack for 15 minutes before applying and a cold pack for 10 minutes after applying. Both groups were treated three times with an interval of three days. Before and after treatment were evaluated lower extremity (hamstring and quadriceps) muscle strength with an isokinetic dynamometer (CSMI Humac-Norm), balance performance with BBS (Biodex Balance System), lumbar range of motion and mobility with inclinometer and hand finger floor distance (HFFD), low back pain intensity with visual analog scale (VAS), functional status with Modified Oswestry low back pain disability questionnaire (OSW), quality of life with Short form-36 (SF-36) in both groups. SPPS 25 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) version was used to analyze the data.

Detailed Description

This study is aimed to compare the effects of chiropractic spinal manipulative therapy and spinal decompression device treatment on lower extremity muscle strength, balance performance, lumbar range of motion and mobility, functional status, pain, and quality of life in patients with chronic low back pain.

Chronic low back pain is a multifactorial disease that occurs especially in adults and has many negative effects on daily quality of life. This disease, which affects 70-80 percent of adults throughout their lives, creates significant limitation and high psycho-social burden in daily life due to the fact that the pain lasts more than 12 weeks. This leads to high health costs as well as loss of labor and economic burden.

The etiology of chronic low back pain varies according to the patient population, but the most common is mechanical and non-specific. 80-90 percent of low back pain is caused by mechanical low back pain, and 15-25 percent of these patients have chronic facet joint-induced low back pain caused by chronic inflammation and degeneration of the lumbar facet joints. Chronic low back pain is often thought to be caused by disc and/or vertebral degeneration, musculoskeletal sprain or strain, position of the spine, or movement-related disorders.

Limitation of movement increases due to pain and spasm seen in individuals with low back pain, and physical endurance decreases as a result of decreasing muscle strength and deteriorating posture due to non-use. As a result of this situation, the functional capacity and quality of life of individuals with low back pain are adversely affected.

In studies in individuals with low back pain, atrophy in multifidus and paraspinal muscles, delay in stimulation of the transversus abdominus muscle, decrease in hip abductor muscle strength and trigger points in the gluteus medius muscle have been shown. It has also been shown to have a decrease in hip extensor muscle strength, a decrease in hip flexion, and a significant decrease in hamstring muscle flexibility. In a study investigating knee extensor muscle strength, it was shown that the maximum voluntary contraction and isokinetic muscle strength of the knee extensors were reduced. It has been shown that individuals with chronic low back pain also have a weakened ability to balance due to decreased muscle strength, flexibility, endurance, and many physical changes.

Multifaceted treatment approaches are important because of the long-term and high cost of low back pain treatment. Medical treatment and conservative treatment (electrophysical agents, massage, traction, manipulation, exercise, etc.), public health and preventive rehabilitation programs constitute an important part of the treatment of low back pain.

Traction therapy is a broad term used to refer to any method of separation of the spine along its lower axis using mechanical force. It is used to reduce pain, especially in the cervical and lumbar regions. Traction therapy, which is one of the many treatments that mechanically drain the spine to treat chronic low back pain, has different types such as spinal traction, distraction, and non-surgical spinal decompression.

Spinal decompression (SD) therapy is a new method used as a conservative treatment for low back pain. Using movement and positioning with a traction table or similar motorized device is used to reduce pressure that can cause severe pain in the spine without any surgical procedure. Although it is generally suggested that this traction-based treatment is superior to existing classical traction devices, its basic principle is spinal distraction, which is thought to increase the distance between interververtebral discs by relaxing neural structures with its mechanical effects . Disc herniation or bulging creates a negative intervertebral pressure for the withdrawal and repositioning of disc material, and thanks to low pressure, it increases the fluid in the disc and the flow of fluids that nourish the disc.

Chiropractic consists of the Greek words chiro (hand) and practic (practice) and means "manual practice." Chiropractic, which is an evidence-based primary health care, is generally preferred by people with low back and neck pain in developed countries. In biomechanical disorders of the musculoskeletal and spinal systems that have not reached the surgical level, the complex of vertebral subluxation caused by isolated axis disorders, mechanical movement integrity and disruption of physiological functions or their negative effects on the nerve, muscle, ligaments, circulation and movement systems Chiropractic manipulations applied for the purpose of correction are an easy-to-apply, non-invasive, cost-effective and low form of treatment with side effects.

Although there are many studies in the literature in which the effects of conservative treatments used in the treatment of individuals with chronic low back pain are independently examined or compared with each other, there have been no studies comparing chiropractic manipulation and non-surgical spinal decompression treatments.

After the approval of the ethics committee, the research was carried out in the physical therapy and rehabilitation clinic of Medipol Mega University Hospital. Individuals between the ages of 18-60, who had complaints of low back pain for the last three months and who voluntarily agreed to participate in the study were included in the study. 40 participants with low back pain existing more than 3 months were randomized into one of two groups as Chiropractic Spinal Manipulative Therapy (CSMT) and Spinal Decompression (SD). Lumbar region chiropractic HVLA (High Velocity, Low Amplitude) spinal manipulation and/or sacroiliac joint chiropractic HVLA manipulation was applied to CSMT group, and lumbar region spinal decompression (traction) device therapy was applied to SD group, and as a standard of treatment was given a hot pack for 15 minutes before applying and a cold pack for 10 minutes after applying. Both groups were treated three times with an interval of three days. Before and after treatment were evaluated lower extremity (hamstring and quadriceps) muscle strength with an isokinetic dynamometer (CSMI Humac-Norm), balance performance with BBS (Biodex Balance System), lumbar range of motion and mobility with inclinometer and hand finger floor distance (HFFD), low back pain intensity with visual analog scale (VAS), functional status with Modified Oswestry low back pain disability questionnaire (OSW), quality of life with Short form-36 (SF-36) in both groups. SPPS 25 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) version was used to analyze the data.

Study Timeline

• Study Start: 2020-12-16
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Low back pain for more than 3 months
• Presence of sacroiliac and lumbar spine asymptomatic dysfunctions in tests

Exclusion Criteria

• Not wanting to continue education
• Not being able to come to assessments
• Having low back pain after COVID-19
• Being spinal manipulation or spinal decompression treatment recently
• Having any neurological or psychiatric illness
• Having a fracture in the past
• Having a tumor in the past
• Lumbar disc hernias, spondylosis, spondylolisthesis
• Having a disease related to the cardiac and respiratory system
• Having an infectious, rheumatological, metabolic, and endocrine disease
• Having dislocation, osteoporosis, ankylosing spondylitis, discopathy, rheumatoid arthritis
• Having instability, acute myelopathy, or being anticoagulants treatments
• Having surgery recently

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SD group	Spinal Decompression Device Treatment	Spinal Decompression group
CSMT group	Chiropractic Manipulation	Chiropractic Spinal Manipulative Treatment group

Primary Outcome Measures

Name	Time	Method
Balance Performance: Postural Stability Test (PST), Fall Risk Test (FRT) and Balance Error Scoring System (BESS)	2 weeks	Static and dynamic balance performances of the participants were measured with the biodex balance system, which is a validated and reliable device that can be used to assess postural stability, balance error score and fall risk. This system, which can objectively measure balance performance, consists of a mobile platform, arm supports, screen and printer, whose surface can be tilted up to 20 degree in 360 degree range of motion. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degree in each direction) according to the test to be applied.
Lower Extremity Muscle Strength: Hamstring and Quadriceps Isokinetic Test	2 weeks	In the measurement of lower extremity muscle strength of the participants, Quadriceps and Hamstring isokinetic peak torque values were measured with isokinetic dynamometer (CSMI-Cybex Humac-Norm Testing \& Rehabilitation System). Maximal reciprocal concentric isokinetic knee extension and flexion of the participants were measured at three different angular speeds; slow (60°/s, 5 reps, 10 s rest), moderate (120°/s, 10 reps, 10 s rest) and fast (180°/s, 15 reps, 10 s rest)
Lumbal Region Range of Motion and Mobility Measurements: Inclinometer (Trunk Flexion and Extension) and Hand Finger-Floor Distance (HFFD)	2 weeks	Lumbal region range of motion of the participants (trunk flexion and extension) were measured with an inclinometer. The inclinometer, as its working principle, can be used in sagittal and frontal plane movements because it measures the angle between the in-app axis and the direction of gravity.; Lumbar mobility of the participants was evaluated with the hand finger-floor distance (HFFD) test. Participants were leaned forward as much as they can, standing, hands-free, without bending their knees. The measurement of the distance between the third finger of the participants and the floor was recorded.
Quality of Life Measurements: Short-Form 36 (SF-36)	2 weeks	Quality of life measurement of the participants were evaluated with a Short Form-36, which is the most commonly used quality of life scale in the medical field. This questionnaire consists of 8 sub-scales with a total of 36 items that evaluate physical and mental health. These subscales are physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitation, and mental health. It was found to be valid and reliable in patients with osteoarthritis and chronic low back pain. The scores range from 0-100, with 100 points indicating the best health condition and 0 points the worst health condition.
Functional Status Measurement: Oswestry Low Back Pain Disability Questionnaire (OSW)	2 weeks	Functional status measurement of the participants were evaluated with a Oswestry Low Back Pain Disability Questionnaire (OSW). This questionnaire measures disability in 10 different aspects (intensity of pain, personal care, lifting, walking, sitting, standing, sleep, social life, travel, change in the amount of pain) in order to evaluate the effect of low back pain on activities of daily living. Each item consists of six options in itself. The patient marks the option that best expresses his or her condition. The first option gets a score of "0" and the sixth option gets a score of "5". The level of functionality expressed by the scores is as follows; (0-4 points no disability), (5-14 points mild), (15-24 points moderate), (25-34 points severe), (35-50 points range of complete functional disability). The minimum score obtained from the scale is 0, and the maximum score is 50. 50 points indicate that functional disability is at the highest level.
Pain Intensity Measurements: Visual Analog Scale (VAS-Rest and VAS-Movement)	2 weeks	Pain intensity measurements of the participants were evaluated with a visual analog scale (VAS-Rest and VAS-Movement) numbered equal intervals from 0 to 10 on a 10 cm line, which is used to digitize some values that cannot be measured numerically. 0 means no pain and 10 means unbearable pain. Thus, participants was asked to mark the intensity of pain they perceive.

Trial Locations

Locations (1)

Medipol Mega University Hospital; 🇹🇷 Istanbul, Turkey