Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain

NCT04691024 | Completed DMC

• 1 other identifier: KA-20111
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Neck pain is a problem that recurs at certain stages of life and can affect approximately half of the population. A problem in the cervical region can cause problems such as pain and limitation in the surrounding joints. Doing a job with functional activity or fulfilling professional requirements can aggravate neck pain. As a result, anatomical, physiological and psychological systems emerge as factors affecting pain. Determining the disability of the individual and the effectiveness of rehabilitation can be demonstrated with functional capacity assessment. It is stated that in individuals with chronic neck pain, architectural features such as functional cross-sectional area of deep neck muscles and reduction of muscle thickness change. Muscle preservation may increase as pain increases, and more protection too; Limitations can further increase conditions such as pain. In addition to the problem being only in the neck region, the whole spine posture may change, and the lumbar region muscles may also weaken by considering the spine as a whole. It is stated that the muscular architectural properties of the cervical and lumbar region, which play an important role in the posture of the spine in individuals with chronic neck pain, can be improved with exercise. During the 2020 years' pandemic process, the time spent at home, the use of mobile devices, the duration of working at home on a desk increased, and increases in spine pain reported to professionals were observed. The fact that family members are at home has increased the workload of the home and the frequency of performing functional activities has increased. It is reported that the distance between physiotherapists and patients should be at least 2 meters in clinics due to the risk of contamination. As a result, the pandemic process has brought the remote exercise management, tele-rehabilitation process to the fore for physiotherapists and the society. With spinal stabilization exercises, the functional level and muscle architecture of individuals with chronic neck pain can be associated with architectural changes in the spinal muscles. As a result of the 2020 years' pandemic, it is not known whether remote exercise and face-to-face exercises will have different effects on clinical variables, functional activities, muscle architecture, together with difficulties in accessing clinics. The aim of the study is to investigate the effects of remote spinal stabilization exercises on functional level and muscle architecture on individuals with chronic neck pain.

Conditions

Neck Pain

Keywords

neck pain; spinal stabilization exercises; tele-rehabilitation; muscle architecture; functional level

Outcome Measures

Primary Outcomes (4)

• Evaluation of Muscle Thickness with Ultrasonography

  Ultrasonography is used to evaluate the architectural properties of the muscle (such as thickness) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). Within the scope of our study, the muscle thickness of the spinal muscles will be evaluated in the resting position.

  15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks

• Evaluation of the Functional Cross Sectional Area with Ultrasonography

  Ultrasonography is used to evaluate the architectural properties of the muscle (such as he Functional Cross Sectional Area (FCSA)) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). Within the scope of our study, the muscle FCSA of the spinal muscles will be evaluated in the resting position.

  15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks

• Evaluation of Functional Capacity Level with Functional Capacity Assessment Test

  Functional capacity assessment evaluates the effectiveness (time to completion, weight it can handle) of each activity that includes different activities for neck pain. The test includes the activities of "repetitive reaching out, lifting objects overhead, working overhead". The validity and reliability of the Functional Capacity Assessment Test in individuals with chronic neck pain has been shown. The time individuals can complete the tests will be recorded.

  20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

• Evaluation of Functional Capacity Level with Back Performance Scale

  The back performance test (Back Performance Scale) is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.

  10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

Secondary Outcomes (7)

• Evaluation of pain severity

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks

• Evaluation of disability

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks

• Evaluation of neck awareness

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks

• Evaluation of quality of life

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks

• Evaluation of Exercise Adherence Assessment: Exercise Adherence Rating Scale (EARS) (EUAS)

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises

Other: Exercise

Control Group

OTHER

Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises

Other: Exercise

Interventions

Exercise OTHER

Spinal stabilization exercises

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having neck pain for at least 3 months,
• Between the ages of 18-55,
• Being literate,
• Individuals who are capable of understanding exercises (Montreal Cognitive Assessment Scale (MOCA) total score\> 21) will be included in the study.

You may not qualify if:

• Cervical radiculopathy, thoracic outlet syndrome,
• Malignant condition,
• Having systemic diseases such as neurological, psychological, cardiovascular and loss of function due to these diseases,
• A history of surgery in the spine and upper extremity, including the cervical region, in the last 1 year period,
• Fracture in the spine and upper extremity, including the cervical region, with a history of inflammation,
• Acute infection,
• Continuing another rehabilitation program,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06000, Turkey (Türkiye)

Location

Related Publications (1)

• Onan D, Ulger O, Martelletti P. Effects of spinal stabilization exercises delivered using telerehabilitation on outcomes in patients with chronic neck pain: a randomized controlled trial. Expert Rev Neurother. 2023 Mar;23(3):269-280. doi: 10.1080/14737175.2023.2192870. Epub 2023 Mar 22.

  PMID: 36927237 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 31, 2020
• Study Start: January 25, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)