Comparison of the Effectiveness of Different Exercise Types in Individuals with Chronic Neck Pain

NCT06697457 | Recruiting

• 1 other identifier: MSKU-FTR-ACP-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain.

Conditions

Chronic Neck Pain

Keywords

neck pain; chronic; exercise

Outcome Measures

Primary Outcomes (3)

• Pain Assesment

  The assessment will be made with Visual Analogue Scale (VAS) and algometer. VAS is considered both valid and reliable in measuring the pain intensity of patients. Each participant will be asked to indicate the intensity of pain they have experienced in the previous 24 hours. This will be done by marking on a 10 cm line where "0" is "No Pain" and "10" is "Maximum Pain".

  8 week

• Pain Assesment

  An algometer with a 1 cm2 rounded surface area will be used for objective pain assessment. Measurements will be made on the spinous processes of C2 and c5 and the trapezius muscle. The assessor will gradually increase the pressure until pain or discomfort occurs and the patient says "yes". The average of the three measurements will be taken. A 30-second rest period will be given between each measurement.

  8 week

• Disability Assesment

  Neck Disability Index, designed to assess how neck pain affects daily living activities, will be used. The questionnaire includes 10 items that measure disability secondary to neck pain. Scores range from 0-50 and are interpreted as follows: * 0-4 represents no disability, * 5-14 represents mild disability, * 15-24 represents moderate disability, * 25-33 represents severe disability, * 34 and above represents complete disability.

  8 week

Secondary Outcomes (8)

• Cervical Joint Range of Motion Assessment

  8 week

• Cervical Postur Assesment

  8 week

• Cervical Postur Assesment

  8 week

• Cervical Strength Assessment

  8 week

• Cervical Endurance Assessment

  8 week

Study Arms (4)

Conventional Treatment

ACTIVE COMPARATOR

Conventional treatment will include electrotherapy agents (TENS, ultrasound and hotpack) and chin tuck posture exercises.

Other: Conventional Treatment Group

Craniocervical Flexion Exercise Training

ACTIVE COMPARATOR

Patients will receive exercise in addition to conventional treatment. The exercises will be performed with an air-filled pressure stabilizer placed in the sub-occipital region.

Other: Craniocervical Flexion Exercise Group; Other: Conventional Treatment Group

Dynamic Isometric Exercise Training

ACTIVE COMPARATOR

Patients will receive exercise in addition to conventional treatment. The exercises will be performed by the patient with an elastic band.

Other: Conventional Treatment Group; Other: Dynamic Isometric Exercise Group

Static Isometric Exercise Training

ACTIVE COMPARATOR

Patients will receive exercise in addition to conventional treatment. The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position.

Other: Conventional Treatment Group; Other: Static Isometric Exercise Group

Interventions

Craniocervical Flexion Exercise Group OTHER

The patient will first be taught to contract the deep cervical flexors. Patients will be placed in a supine position (without a pillow) to ensure a neutral neck position. Patients will be asked to perform slow, controlled head and upper cervical flexion by bringing the chin closer to the chest ("yes" movement). The stabilizer will be inflated to 20 mmHg. Gradual training will be given to increase the pressure value by 2 mmHg between 20 and 30 mmHg. Each pressure value (22, 24, 26, 28 mmHg) will be held for 10 seconds and repeated 10 times. The exercise will be performed with 10 repetitions, 10 seconds of contraction and 5 seconds of relaxation. Exercise training will begin with 20 mmHg and once the patient can hold it for 10 seconds with 10 repetitions, the next level on the pressure stabilizer will be moved on.Treatments will be performed 3 days a week for 8 weeks.

Craniocervical Flexion Exercise Training

Conventional Treatment Group OTHER

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Conventional Treatment; Craniocervical Flexion Exercise Training; Dynamic Isometric Exercise Training; Static Isometric Exercise Training

Dynamic Isometric Exercise Group OTHER

The exercises will be performed by the patient with an elastic band. The progression of the exercises will be performed using different colors of Thera-bands with different resistances. It will start with the red Thera-band with the lowest resistance and then move on to the green and then blue Thera-bands with increasing resistance. Cervical isometric exercises will be performed with elastic resistance bands, maintaining the chin tuck position, forward, backward, crosswise, right and left. There will be 10 repetitions for 10 seconds for each. Progression in Therabands will be according to the patient. When the patient does 10 repetitions for 10 seconds, the next Theraband will be used.Treatments will be performed 3 days a week for 8 weeks.

Dynamic Isometric Exercise Training

Static Isometric Exercise Group OTHER

The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position. Each exercise will be performed for 10 seconds, with 15-second breaks in between, for 10 repetitions. Each patient will start with submaximal resistance to help them adapt to isometric exercises, and then progress will be checked until the patient reaches the maximum resistance that can be tolerated by each session. It will consist of cervical flexion, cervical extension, right lateral flexion, left lateral flexion, right rotation, left rotation exercises. Progress in the exercises will be according to the Rating of Perceived Exertion Borg (RPE) Scale according to the weeks.Treatments will be performed 3 days a week for 8 weeks.

Static Isometric Exercise Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18 and 55,
• Scoring 15/50 or less on the Neck Disability Index,
• Having a history of chronic neck pain for at least 3 months,
• Having a pain level of 5/10 or more,
• Showing signs of cervical movement control dysfunction,
• Having cervical muscle tenderness during physical examination.

You may not qualify if:

• Being diagnosed with a vascular disease,
• Being diagnosed with a vestibular disease,
• Being diagnosed with hypertension,
• Being diagnosed with fibromyalgia or rheumatoid arthritis,
• Having had spine surgery in the last 12 months,
• Having received an exercise program or standard physiotherapy program involving the cervical region in the last 12 months,
• Having congenital or acquired kyphosis, scoliosis, etc. having postural deformity,
• Having specific neck pain such as cancer,
• Having fractures, instability, inflammatory diseases, history of neck trauma, infections, neurological deficit, having spinal diseases such as radiculopathy, spondylosis.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Education and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain; Bronchiolitis Obliterans Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Behavior

Central Study Contacts

Ayşen Canan Pakeloğlu, Physiotherapist

CONTACT

+905059102642; aysencanan95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessors and patients were not informed about group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist Ayşen Canan Pakeloğlu

Model Details: Four groups, parallel, randomized controlled

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: June 24, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)