NCT06407479

Brief Summary

It was aimed to compare the eccentric exercise training given to the neck muscles of people with non-specific neck pain and the proprioceptive neuromuscular facilitation (PNF) technique on pain, endurance and functionality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

May 6, 2024

Last Update Submit

July 31, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Cervical Deep Flexor Muscle Endurance Test

    Patients were asked to lie in a supine position with knees flexed at 90° and hands on the abdomen in a hook position. A 0.5 kilogram (kg) weight was placed on the forehead with the help of a band passed over the ears. The patients were asked to first perform cervical retraction and then 10° cervical flexion, and the degree of flexion was determined with the help of a goniometer. The patients were asked to maintain this position and the time was determined with a stopwatch and recorded in seconds. Patients must be able to maintain this position for 60 seconds (sec) in order to have sufficient muscle endurance. Those below this period have insufficient muscle endurance. Cervical flexion for 60 seconds. Patients holding it above were considered to have sufficient endurance and were not included in the study.

    8 weeks

  • World Health Organization Quality of Life Survey Short Form

    The scale measures 28 general health, physical, psychological, social and environmental well-being and consists of 26 questions. Turkey version consists of 27 questions. The 27th question is the national question that determines the Environmental Score. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.

    8 weeks

  • Neck Disability Index

    Neck Disability Index will be used to evaluate the disability specific to neck pain. The Neck Disability Index has been modified from the Oswestry Disability Index. It consists of 10 sections: pain intensity, personal care, weight bearing, reading, headache, concentration, working, driving, sleep and recreational activities. Each section consists of 6 answers and is scored from 0, no disability, to 5, representing total disability. According to total score; 0-4: no limitation, 5-14: mild limitation, 15-24: moderate limitation, 25-34: severe limitation, 34 and above: completely limited.

    8 weeks

  • Tampa Kinesiophobia Scale

    Tampa Kinesiophobia Scale was used to evaluate kinesiophobia, which is a state of anxiety that develops against activity and physical movement due to fear of pain and re-injury. It was developed to differentiate between non-excessive fear and phobia in patients with chronic musculoskeletal pain. It is frequently used in the literature to evaluate movement-related fear and anxiety. The scale is a 17-item scale that includes parameters of injury, re-injury and fear-avoidance in work-related activities. As the score increases, it is accepted that the kinesiophobia of the individual with pain increases.Results consist of a total raw score (range between 17 and 68) A low score indicates low kinesiophobia.

    8 weeks

  • Cervical joint goniometric measurements

    Goniometric measurements in the neck are methods used to evaluate and record neck joint range of motion. These measurements are important to evaluate the patient's condition during the treatment process, follow the progress and create the treatment plan.

    8 weeks

Study Arms (3)

proprioceptive

EXPERIMENTAL

proprioceptive neuromuscular facilitation technique application

Other: proprioceptive neuromuscular facilitation technique group

eccentric

EXPERIMENTAL

eccentric muscle training technique application

Other: eccentric muscle training technique application group

Control

ACTIVE COMPARATOR

no intervention group

Other: Control

Interventions

Proprioceptive Neuromuscular Facilitation Technique group; In addition to the exercises applied to the participants and the control group, combined isotonic contractions and dynamic stabilization will be used as facilitation techniques, and hold-relax technique will be used as an inhibition technique.

proprioceptive

Eccentric Muscle Training Technique: Participants will receive eccentric muscle training in addition to the exercises given to the control group. Before the application, 5-minute warm-up exercises will be given to the neck area. Eccentric muscle training will be applied to the muscles of the participants in the cervical region. Eccentric exercise will be strengthened in the cervical region muscles in the direction of movement in each plane, that is, flexion / extension and lateral flexion. The movements will first be explained and demonstrated to the patient.

eccentric
ControlOTHER

No intervention will be made.

Control

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65
  • History of neck pain that has persisted for at least 7 days
  • Agreeing to participate in the study

You may not qualify if:

  • Radiculopathy and structural disorder in the cervical region,
  • Surgery to the cervical region,
  • Inflammatory disease,
  • Severe psychological illness,
  • Presence of infection in the bone and soft tissue in the cervical spine,
  • Malignancy,
  • Advanced osteoporosis,
  • Those with upper extremity pathologies,
  • Having a neurological disease that will prevent treatment
  • Having previously undergone cervical region and spine surgery
  • Having been included in a physiotherapy program for the neck and back area in the last 6 months,
  • It was defined as the administration of drugs such as NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) and opioids in the last 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.

    PMID: 22349588BACKGROUND
  • Heredia-Rizo AM, Petersen KK, Madeleine P, Arendt-Nielsen L. Clinical Outcomes and Central Pain Mechanisms are Improved After Upper Trapezius Eccentric Training in Female Computer Users With Chronic Neck/Shoulder Pain. Clin J Pain. 2019 Jan;35(1):65-76. doi: 10.1097/AJP.0000000000000656.

    PMID: 30222615BACKGROUND
  • Espi-Lopez GV, Aguilar-Rodriguez M, Zarzoso M, Serra-Ano P, Martinez DE LA Fuente JM, Ingles M, Marques-Sule E. Efficacy of a proprioceptive exercise program in patients with nonspecific neck pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Jun;57(3):397-405. doi: 10.23736/S1973-9087.20.06302-9. Epub 2020 Oct 13.

    PMID: 33047944BACKGROUND
  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

    PMID: 28826164BACKGROUND
  • Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417.

    PMID: 32207413BACKGROUND

MeSH Terms

Conditions

Neck PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Büşra SÖKMEN YILDIRIM

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 9, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations