NCT05154526

Brief Summary

Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

First Submitted

Initial submission to the registry

November 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

November 13, 2021

Last Update Submit

May 24, 2023

Conditions

Keywords

neck painmechanical neck painmanual therapyexercise

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index

    The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).

    6 weeks

  • Pain intensity

    Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.

    6 weeks

Secondary Outcomes (4)

  • Range of Motion (ROM)

    6 weeks

  • Pain Pressure Threshold (PPT)

    6 weeks l

  • 36-Item Short Form Survey (SF-36)

    6 weeks

  • Patient satisfaction level

    At the end of 6-weeks

Study Arms (3)

Exercise Group

EXPERIMENTAL

Exercise Program only

Other: Exercise Program

Manual Therapy Group

ACTIVE COMPARATOR

Manual Therapy only

Other: Manual Therapy

Manual Therapy and Exercise Group

ACTIVE COMPARATOR

Manual Therapy + exercise program

Other: Manual TherapyOther: Exercise Program

Interventions

Manual Therapy: High velocity-low amplitude technique

Manual Therapy GroupManual Therapy and Exercise Group

Exercise program

Exercise GroupManual Therapy and Exercise Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with MNP
  • Decrease in cervical region ROM
  • Ability to adapt to verbal, written and visual instructions

You may not qualify if:

  • Spine surgery history
  • Neurological neck pain in the cervical region
  • Presence of tumor in the cervical region
  • Blood coagulation disorders
  • Vertebrobasilar artery insufficiency
  • Cervical region trauma history
  • Communicative/mental problems that prevent participation in treatment
  • Inflammatory rheumatological diseases affecting the cervical region
  • Physiotherapy and rehabilitation treatments for neck pain in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMobility LimitationMotor Activity

Interventions

Musculoskeletal ManipulationsResistance Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yıldız Analay Akbaba, PhD

    Istabul University-Cerrahpasa

    STUDY DIRECTOR

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
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 13, 2021

First Posted

December 13, 2021

Study Start

December 13, 2021

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations