Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness

NCT07048093 | Not Yet Recruiting

• 1 other identifier: G.O. 2024/153
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine whether relaxation exercises performed before cranio-cervical flexion can reduce superficial neck muscle activation (specifically sternocleidomastoid and upper trapezius) in individuals with neck pain. The main questions it aims to answer are:

• Does performing relaxation exercises prior to cranio-cervical flexion reduce sternocleidomastoid (SCM) muscle activation?
• Does it reduce upper trapezius muscle activation during the standing? Researchers will compare the group performing relaxation exercises before cranio-cervical flexion to the group performing only cranio-cervical flexion to see if there is a measurable difference in superficial neck muscle activation. Participants will:
• Perform cranio-cervical flexion exercises.
• Perform relaxation exercises prior to the cranio-cervical flexion (intervention group only).
• Undergo surface EMG measurements to assess muscle activity.

Conditions

Non Specific Chronic Neck Pain

Keywords

Relaxation Exercise; craniocervical flexion; upper trapezius

Outcome Measures

Primary Outcomes (4)

• Numerical Pain Rating Scale

  On the numerical pain scale, the patient will be asked, "0 means no pain at all, 10 means unbearable pain, representing the worst pain/unbearable pain you have ever experienced. On a scale of 0 to 10, how would you rate your pain?"

  At enrollment (pre-intervention) and immediately after the relaxation exercise intervention or sham intervention (Day 1)

• Turkish Version of Core Outcome Measure Index for Neck Pain

  The first question consists of two 10-point numerical pain scales that ask about neck and arm-shoulder pain. Whichever of these two questions receives a higher response is used. The other five questions are five point Likert-type response questions. The six items cover five dimensions: pain intensity (neck and arm/shoulder pain), neck-related function, symptom-specific well-being, overall quality of life, and disability (social and work). The total score is calculated by taking the average of all responses. To form the Core Outcome Measure Index summary score, each of the dimension scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status.

  At enrollment (pre-intervention)

• EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver

  EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver standardized with Stabilizer Pressure Biofeedback Device

  At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)

• EMG Activation Level of Upper Trapezius Muscle During Standing Still

  EMG Activation Level of Upper Trapezius Muscle During Standing Still

  At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)

Study Arms (2)

Relaxation Exercises Group

EXPERIMENTAL

This group will do relaxation exercises based on reciprocal inhibition, autogenic inhibition, proprioceptive training and postural training.

Other: Exercise

Just Lie Back Group

SHAM COMPARATOR

This group do nothing but just lie back before and after actual measurements.

Other: Sham (No Treatment)

Interventions

Exercise OTHER

Average of 10 minutes relaxation exercises guided with a standard audio record based on reciprocal and autogenic muscle inhibition, proprioceptive training and postural training.

Relaxation Exercises Group

Sham (No Treatment) OTHER

This group take no treatment between actual before and after measurements.

Just Lie Back Group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knowledge of Turkish
• Chronic (at least three months) neck pain
• Neck pain level of 4 or higher on a numerical pain scale

You may not qualify if:

• Neck pain caused by a tumor, trauma, or rheumatic disease
• History of surgery involving the head, neck, shoulder, or thoracic region
• Root compression
• Regular use of painkillers due to another illness
• Another illness severe enough to interfere with work

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Faculty of Health Sciences

Balıkesir, Balıkesir, 10145, Turkey (Türkiye)

Location

Related Publications (4)

• Rota E, Evangelista A, Ceccarelli M, Ferrero L, Milani C, Ugolini A, Mongini F. Efficacy of a workplace relaxation exercise program on muscle tenderness in a working community with headache and neck pain: a longitudinal, controlled study. Eur J Phys Rehabil Med. 2016 Aug;52(4):457-65. Epub 2016 Jan 8.

  PMID: 26745361 BACKGROUND

• Lee BK, Seo DK. The Importance of Optimal Gaze Direction on Deep Neck Flexor Activation in Chronic Neck Pain. Healthcare (Basel). 2020 Nov 1;8(4):449. doi: 10.3390/healthcare8040449.

  PMID: 33139645 BACKGROUND

• Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.

  PMID: 34980079 BACKGROUND

• Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.

  PMID: 19632880 BACKGROUND

MeSH Terms

Interventions

Exercise; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Utku Berberoğlu, PhD

CONTACT

+902666121400; utku.berber@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: July 2, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

TU (1)