Clinical trial NCT06704373: The Effects of Thoracic Manipulation on Peripheral Muscle Oxygenation
Official title: Effect of Thoracic Manipulation on Peripheral Muscle Oxygenation, Pain, and Disability in Office Workers With Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain
Spine Stiffness
Sedentary Behavior
Disability Physical
Keywords: moxy
spinal pain
sedantary
chiropractic
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into intervention (manipulation group) and control group.
Primary purpose: TREATMENT

Brief summary: Office workers spend 70-85% of their time sitting, which leads to postural disorders and musculoskeletal system diseases. Back pain is the most common health problem among office workers who need to sit. Studies have shown that spinal manipulation can help reduce back pain by decreasing the stiffness of spine segments associated with joint dysfunction. The primary aim of this study is to investigate the effects of thoracic spinal manipulation on peripheral oxygenation, pain, and disability of the back muscles in office workers with back pain, at acute, 10-day, and 4-week follow-up periods. The secondary aim is to evaluate whether the parameters have a significant relationship.

The study will include volunteers aged 20-50 who are active office workers with no orthopedic, neurological, or psychological disorders, who have experienced back pain in the last 3 months, and who have a numerical pain scale score of at least 30 mm out of 100 mm. Participants will be randomized into the thoracic spinal manipulation and the control groups. Both groups will receive postural exercises. The thoracic spinal manipulation group will receive a single session of spinal manipulation, while the control group will only receive postural exercises. The study is expected to find significant improvement in peripheral muscle oxygenation, back pain, and disability scores following thoracic spinal manipulation. This study aims to contribute to the literature by focusing on how peripheral muscle oxygenation is affected by thoracic spinal manipulation.

Detailed description: Office workers spend 70-85% of their time sitting at their workplaces, with an average working time of 8 hours. This prolonged inactivity can lead to serious health issues such as musculoskeletal disorders, repetitive movements, static postures, and improper body positions. Due to their limited mobility, office workers are at risk of experiencing problems with their body postures. Studies have shown that back pain is a common issue among office workers. However, thoracic spine pain between the T1-T12 vertebrae is less studied and less debilitating than cervical and lumbar pain. The most common causes of back pain are muscle tension, trauma, acute injury, strain, or poor posture. The posture, mobility, and stability of the thoracic spine are important factors in pain syndromes and degenerative changes. The success of treatment relies on understanding the anatomy and biomechanics of the spine. Research on mechanoreceptor effects is significant for manual therapy, including spinal manipulation and mobilization techniques. These therapies target intervertebral joints and affect adjacent joints and surrounding soft tissues. Chiropractic spinal manipulation, performed by professionals at the intersection of traditional and alternative medicine, has been found effective in treating back pain and reducing pain. Thoracic spinal manipulation may help relax spinal segments associated with secondary muscle spasms due to joint dysfunction. Studies have shown significant improvements in range of motion and pain in the acute period following thoracic manipulation. Spinal manipulation combined with exercise can enhance an individual's quality of life and improve pain conditions.

NIRS (near-infrared spectroscopy) has been used to measure the oxygen status of muscle tissue, demonstrating the balance between muscle oxygen delivery and tissue V̇O2. The fascial system encompassing the large muscle groups in the back can lead to muscle overload, reducing blood flow and creating myofascial adhesions. A recent study presented initial evidence that myofascial reorganization techniques could improve trapezius muscle tissue oxygenation and peripheral blood flow in patients with neck pain.

To our knowledge, there are no studies evaluating the effect of spinal manipulation on muscle oxygenation in individuals with back pain. Our research aims to contribute to the literature by examining the changes in oxygenation, pain, and disability in the upper trapezius and interscapular region and lumbar spine muscles following a single session of thoracic spinal manipulation.

Eligibility criteria: Inclusion Criteria:

* Active desk-based office worker for the past 3 months
* Age between 20 and 50 years
* Back pain experience in the last 3 months
* Willing to participate in the study

Exclusion Criteria:

* Diagnosis of osteoporosis
* Presence of a newly formed fracture
* Recent trauma
* Cancer
* Osteomyelitis
* Hypermobility
* Ankylosing spondylitis
* Presence of an aneurysm
* Presence of vascular occlusion
* Malignancies

Primary outcomes:
measure: Periferal muscle oxygen measurement
timeFrame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
measure: Neck Disability Index
timeFrame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
measure: Numeric Pain Scale
timeFrame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Other outcomes:
Locations:
city: Besiktas
country: Turkey
facility: Bahcesehir University
state: Istanbul
Study officials:
affiliation: Bahcesehir University, Graduate Education Institute,Chiropractic Master of Science Program
name: Alev Atasever, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahcesehir University, Faculty of Health Sciences
name: Pelin Pişirici, PT, PhD
role: STUDY_DIRECTOR
affiliation: Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation
name: Berkay Eren Pejlivanoğlu, PT, PhD
role: STUDY_CHAIR
References: