NCT04420403

Brief Summary

This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

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

May 20, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

May 29, 2020

Last Update Submit

December 14, 2021

Conditions

Keywords

neck painmanual therapyexercisepostural control

Outcome Measures

Primary Outcomes (1)

  • Balance

    The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.

    change from baseline at 6 weeks

Secondary Outcomes (4)

  • Proprioception

    change from baseline at 6 weeks

  • Muscle morphology

    change from baseline at 6 weeks

  • Pain intensity

    change from baseline at 6 weeks

  • Disability level

    change from baseline at 6 weeks

Study Arms (2)

Manual therapy plus cervical stabilization exercise group

EXPERIMENTAL

The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.

Other: Manual TherapyOther: Cervical Stabilazation Exercise (CSE)

Only manual therapy group

ACTIVE COMPARATOR

The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.

Other: Manual Therapy

Interventions

Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.

Manual therapy plus cervical stabilization exercise groupOnly manual therapy group

The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.

Manual therapy plus cervical stabilization exercise group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years of age,
  • Having generalized neck pain for more than 3 months,
  • Being volunteer

You may not qualify if:

  • Being pregnant,
  • Malignancy,
  • Having cervical stenosis,
  • Severe cervical spondylosis,
  • Cervical fractures and tumor,
  • Osteoporosis,
  • Positive vertebrobasilar test
  • Positive Babinski reflex
  • Neurologic deficit related to compression of the spinal root or cord,
  • Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
  • Being an inability to fulfill the questionnaires,
  • Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • seyda toprak celenay, PhD, PT

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to manual therapy plus cervical stabilization exercise group (intervention group) and only the manual therapy group (control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 9, 2020

Study Start

May 20, 2020

Primary Completion

June 1, 2021

Study Completion

June 24, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations