NCT03194490

Brief Summary

The purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

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

Study Start

First participant enrolled

August 24, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

June 13, 2017

Results QC Date

August 22, 2018

Last Update Submit

October 9, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cervical Range of Motion

    The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.

    Participants ROM measurement at baselines

  • Cervical Range of Motion

    The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.

    Participants ROM measurement at week 2

  • Cervical Range of Motion

    The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.

    Participants measurement at week four

  • Cervical Range of Motion

    The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.

    Participants ROM measurement at week 8

Secondary Outcomes (15)

  • Numeric Pain Rating Scale

    NPRS score at baseline

  • Numeric Pain Rating Scale

    NPRS score at week two

  • Numeric Pain Rating Scale

    NPRS score at week four

  • Numeric Pain Rating Scale

    NPRS score at week eight

  • Neck Disability Index

    NDI score at baseline

  • +10 more secondary outcomes

Study Arms (2)

The combined intervention group

EXPERIMENTAL

The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).

Other: combined intervention group

The standard intervention

ACTIVE COMPARATOR

The standard intervention group will receive cervical mobilization and home program (ROM exercises).

Other: The standard intervention

Interventions

The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy. The cervical passive mobilization were selected by the physical therapist based on the participant's condition. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral.

The combined intervention group

The standard intervention group will receive cervical mobilization and home program (ROM exercises). Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition. Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral .

The standard intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks

You may not qualify if:

  • Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda U

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study had some limitations which they are short follow up period, no control group, and small sample size

Results Point of Contact

Title
Dr. Everett Lohman III
Organization
Loma Linda University

Study Officials

  • Everett B Lohman

    Loma Linda U

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 21, 2017

Study Start

August 24, 2016

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

October 31, 2019

Results First Posted

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations