NCT06704373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

October 2, 2024

Last Update Submit

July 4, 2025

Conditions

Keywords

moxyspinal painsedantarychiropractic

Outcome Measures

Primary Outcomes (1)

  • Periferal muscle oxygen measurement

    Muscle oxygen levels will be measured using the Moxy Monitor. The Moxy Monitor is a mobile, non-invasive method for measuring SmO2. The device uses near-infrared spectroscopy (NIRS) technology and features a patented algorithm that measures hemoglobin and myoglobin in capillaries and muscle tissues with a wearable monitor. Moxy device measures real-time muscle oxygenation (SmO2) and total hemoglobin (tHb) levels by using near-infrared spectroscopy.

    Baseline, right after intervention, ten days after post intervention, four weeks after post intervention

Secondary Outcomes (3)

  • Oswestry Disability Index

    Baseline, right after intervention, ten days after post intervention, four weeks after post intervention

  • Neck Disability Index

    Baseline, right after intervention, ten days after post intervention, four weeks after post intervention

  • Numeric Pain Scale

    Baseline, right after intervention, ten days after post intervention, four weeks after post intervention

Study Arms (2)

Manipulation group

EXPERIMENTAL

Thoracic spinal manipulation will be performed between the T1-T12 vertebral levels, based on the segment with movement limitations. The manipulation will be applied to the area of back pain using a high-velocity, low-amplitude thrust with a short-lever technique. Also, the same postural exercises that were given to the control group will be given.

Other: thoracal manipulationOther: Exercise

Control Group

ACTIVE COMPARATOR

The postural exercises program will be given.

Other: Exercise

Interventions

Thoracal manipulation will be applied only one session.

Manipulation group

Both groups will perform the same postural exercises, which will be applied twice a week for 4 weeks. The intervention group will receive thoracic manipulation for one session.

Also known as: Postural Exercise
Control GroupManipulation group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Beşiktaş, Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back PainSedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alev Atasever, PT

    Bahcesehir University, Graduate Education Institute,Chiropractic Master of Science Program

    PRINCIPAL INVESTIGATOR
  • Pelin Pişirici, PT, PhD

    Bahcesehir University, Faculty of Health Sciences

    STUDY DIRECTOR
  • Berkay Eren Pejlivanoğlu, PT, PhD

    Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into intervention (manipulation group) and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

October 2, 2024

First Posted

November 26, 2024

Study Start

March 10, 2025

Primary Completion

May 15, 2025

Study Completion

May 30, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations