NCT06199063

Brief Summary

Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Many conservative treatment modalities including different exercise techniques are used in the treatment of NSNP. Therefore, the aim of our study was to investigate the effect of these techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

Study Start

First participant enrolled

February 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

November 30, 2023

Last Update Submit

December 27, 2023

Conditions

Keywords

Neck PainMuscle Stretching ExerciseElectromyographyRange of MotionPain Threshold

Outcome Measures

Primary Outcomes (4)

  • Assessment of Pain Severity

    Pain severity was assessed using the Visual Analogue Scale (VAS). The VAS is a subjective pain scale in which the intensity of pain is rated 0-10 cm on a horizontal line. "0" refers to "no pain, while "10" refers to worst pain.

    Before and up to 4 weeks

  • Assessment of Pressure Pain Threshold

    The Wagner digital algometer (Wagner Instruments) was used to measure the pressure pain threshold (PPT). Trigger points in the upper trapezius and cervical paravertebral muscles were palpated and the most painful trigger points were marked as four separate points on the right and left. The algometer was placed perpendicular to the trigger points and the pressure was increased until the first moment when the patient felt pain and the probe was withdrawn with the expression "I felt it/OK". At this point, the PPT value in Newton read from the algometer was recorded in three repetitions.

    Before and up to 4 weeks

  • Assessment of Range of Motion

    The subjects' neck ROMs were recorded in degrees by measuring the degrees of flexion, extension, lateral flexion and rotation three times with a manual goniometer while sitting upright in a chair.

    Before and up to 4 weeks

  • Assessment of Muscle Activation

    Muscle activation was assessed with a MegaWin WBA eight-channel EMG device. Superficial EMG electrodes were placed on the upper trapezius and sternocleidomastoid muscles, right and left. A total of 4 outputs were used, 2 muscles on each side. Myoelectric signals were obtained, and muscular contraction and inhibition were assessed. Additionally, the "IC/MVIC" percentage was calculated to determine the workload on the muscle during the activity.

    Before and up to 4 weeks

Study Arms (3)

Self-Stretching Exercises Group (SSEG)

EXPERIMENTAL

Self-stretching (SS) is defined as stretching applied by the individual to himself/herself. For this application, firstly the painful area was determined, and stretching was applied to the muscle with pain. Firstly, the participant stood with his/her arm free on the side to be stretched and lateral flexed his/her head. With his/her other hand, he/she applied 10 seconds of stretching in the direction of lateral flexion, a 10-second rest period was given between each stretching, and this method was performed with a total of 10 repetitions.

Other: Self-Streching Exercises

Post-Isometric Relaxation Exercises Group (PIREG)

EXPERIMENTAL

Post-isometric relaxation (PIR) was performed by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the painful muscle for 10 seconds. Then, the physiotherapist asked the patient to relax and stretch for 10 seconds to lateral flexion. This method was 10 repetitions with 10 seconds of rest between each repetition.

Other: Post-Isometric Relaxation Exercises

Reciprocal-Inhibition Exercises Group (RIEG)

EXPERIMENTAL

Reciprocal inhibition (RI) was applied by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the antagonist of the painful muscle for 10 seconds. Then physiotherapist asked the patient to relax and stretch for 10 seconds in the lateral flexion direction. This method was 10 repetitions and there were 10 seconds of rest between each repetition.

Other: Reciprocal-Inhibiton Exercises

Interventions

The participants in the SSE group; received 1 session SSE with 10 repetitions, about 30 min. The assessments were applied before and after the session.

Also known as: SSE
Self-Stretching Exercises Group (SSEG)

The participants in the PIRE group; received 1 session PIRE with 10 repetitions, about 30 min. The assessments were applied before and after the session.

Also known as: PIRE
Post-Isometric Relaxation Exercises Group (PIREG)

The participants in the RIE group; received 1 session RIE with 10 repetitions, about 30 min. The assessments were applied before and after the session.

Also known as: RIE
Reciprocal-Inhibition Exercises Group (RIEG)

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • Being a volunteer to participate into the study
  • Not having diagnosed orthopedic and neurological problems
  • Having Neck pain for at least four months

You may not qualify if:

  • Having diagnosed with active infectious pathology
  • Having cervical spine fracture/previous cervical or thoracic surgery
  • Having a history of severe trauma to the cervical spine
  • Having a history of malignant tumors
  • Having diagnosed with structural deformity
  • Being used of a medical orthopaedic prosthesis
  • Having a pacemaker
  • Having diagnosed with disc prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityNeck Pain

Condition Hierarchy (Ancestors)

BehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Betul Taspinar, Prof. Dr.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

November 30, 2023

First Posted

January 10, 2024

Study Start

February 4, 2023

Primary Completion

April 14, 2023

Study Completion

July 4, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations