Comparing the Effect of Chiropractic Manipulation and Spinal Decompression Device Treatment

NCT05460286 | Completed DMC

• 1 other identifier: 10466602
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Balance; Chiropractic; Chronic low back pain; Muscle strength; Manipulation; Spinal decompression; Pain measurement; Range of motion; Recovery of function; Quality of life

Outcome Measures

Primary Outcomes (6)

• Lower Extremity Muscle Strength: Hamstring and Quadriceps Isokinetic Test

  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)

  2 weeks

• Balance Performance: Postural Stability Test (PST), Fall Risk Test (FRT) and Balance Error Scoring System (BESS)

  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.

  2 weeks

• Lumbal Region Range of Motion and Mobility Measurements: Inclinometer (Trunk Flexion and Extension) and Hand Finger-Floor Distance (HFFD)

  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.

  2 weeks

• Pain Intensity Measurements: Visual Analog Scale (VAS-Rest and VAS-Movement)

  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.

  2 weeks

• Functional Status Measurement: Oswestry Low Back Pain Disability Questionnaire (OSW)

  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.

  2 weeks

• Quality of Life Measurements: Short-Form 36 (SF-36)

  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.

  2 weeks

Study Arms (2)

CSMT group

EXPERIMENTAL

Chiropractic Spinal Manipulative Treatment group

Other: Chiropractic Manipulation

SD group

EXPERIMENTAL

Spinal Decompression group

Other: Spinal Decompression Device Treatment

Interventions

Chiropractic Manipulation OTHER

20 participants with low back pain existing more than 3 months was included in the CSMT group. Lumbar region chiropractic HVLA (High Velocity, Low Amplitude) spinal manipulation and/or sacroiliac joint chiropractic HVLA manipulation were applied to participants. Participants 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).

CSMT group

Spinal Decompression Device Treatment OTHER

20 participants with low back pain existing more than 3 months was included in the SD group. Lumbar region spinal decompression (traction) device therapy was applied to participants, 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. Participants 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).

SD group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa AĞRAŞ: lead

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (10)

• Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.

  PMID: 10470716 BACKGROUND

• Parthan A, Evans CJ, Le K. Chronic low back pain: epidemiology, economic burden and patient-reported outcomes in the USA. Expert Rev Pharmacoecon Outcomes Res. 2006 Jun;6(3):359-69. doi: 10.1586/14737167.6.3.359.

  PMID: 20528528 BACKGROUND

• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• Manusov EG. Evaluation and diagnosis of low back pain. Prim Care. 2012 Sep;39(3):471-9. doi: 10.1016/j.pop.2012.06.003.

  PMID: 22958556 BACKGROUND

• Prather H, Cheng A, Steger-May K, Maheshwari V, Van Dillen L. Hip and Lumbar Spine Physical Examination Findings in People Presenting With Low Back Pain, With or Without Lower Extremity Pain. J Orthop Sports Phys Ther. 2017 Mar;47(3):163-172. doi: 10.2519/jospt.2017.6567. Epub 2017 Feb 3.

  PMID: 28158964 BACKGROUND

• Sadler S, Cassidy S, Peterson B, Spink M, Chuter V. Gluteus medius muscle function in people with and without low back pain: a systematic review. BMC Musculoskelet Disord. 2019 Oct 22;20(1):463. doi: 10.1186/s12891-019-2833-4.

  PMID: 31638962 BACKGROUND

• Peterson CK, Bolton J, Humphreys BK. Predictors of improvement in patients with acute and chronic low back pain undergoing chiropractic treatment. J Manipulative Physiol Ther. 2012 Sep;35(7):525-33. doi: 10.1016/j.jmpt.2012.06.003. Epub 2012 Jul 31.

  PMID: 22858233 BACKGROUND

• de Sousa CS, de Jesus FLA, Machado MB, Ferreira G, Ayres IGT, de Aquino LM, Fukuda TY, Gomes-Neto M. Lower limb muscle strength in patients with low back pain: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):69-78.

  PMID: 30839305 BACKGROUND

• Fasuyi FO, Fabunmi AA, Adegoke BOA. Hamstring muscle length and pelvic tilt range among individuals with and without low back pain. J Bodyw Mov Ther. 2017 Apr;21(2):246-250. doi: 10.1016/j.jbmt.2016.06.002. Epub 2016 Jun 16.

  PMID: 28532865 BACKGROUND

• da Silva RA, Vieira ER, Fernandes KBP, Andraus RA, Oliveira MR, Sturion LA, Calderon MG. People with chronic low back pain have poorer balance than controls in challenging tasks. Disabil Rehabil. 2018 Jun;40(11):1294-1300. doi: 10.1080/09638288.2017.1294627. Epub 2017 Mar 10.

  PMID: 28282992 BACKGROUND

MeSH Terms

Interventions

Manipulation, Chiropractic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Ali Veysel ÖZDEN, PhD.

  Bahçeşehir University

  STUDY DIRECTOR

• Sena TOLU, Assoc. Prof.

  Medipol University

  STUDY DIRECTOR

• Mustafa AĞRAŞ, MSc.

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The individuals are randomly allocated into the CSMT or the SD groups

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: December 16, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 1, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)