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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Specific Chronic Neck Pain
• Intervention / Treatment: Other: Exercise; Other: Sham (No Treatment)

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Utku Berberoğlu, PhD; Phone Number: 151315 +902666121400; Email: utku.berber@gmail.com

Study Locations

• Turkey (Türkiye)
  • Balıkesir
    • Balıkesir, Balıkesir, Turkey (Türkiye), 10145
      • Faculty of Health Sciences
      • Contact: Sibel Ergun, Professor; Phone Number: 151330 +902666121400; Email: sibel.ergun@balikesir.edu.tr
      • Contact: Meral Sertel, Professor; Phone Number: 151318 +902666121400; Email: meral.sertel@balikesir.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relaxation Exercises Group; This group will do relaxation exercises based on reciprocal inhibition, autogenic inhibition, proprioceptive training and postural training.	Other: Exercise; Average of 10 minutes relaxation exercises guided with a standard audio record based on reciprocal and autogenic muscle inhibition, proprioceptive training and postural training.
Sham Comparator: Just Lie Back Group; This group do nothing but just lie back before and after actual measurements.	Other: Sham (No Treatment); This group take no treatment between actual before and after measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Balikesir University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 14, 2025
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: upper trapezius; craniocervical flexion; Relaxation Exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; salicylhydroxamic acid
• Other Study ID Numbers: G.O. 2024/153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This ethics committee has not yet established a data policy regarding open data. Otherwise, I would share it once it has been anonymised. I am still discussing this matter with the committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No