Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
1 other identifier
interventional
43
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
1 active site
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
August 24, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2018
CompletedResults Posted
Study results publicly available
October 31, 2019
CompletedOctober 31, 2019
October 1, 2019
1.4 years
June 13, 2017
August 22, 2018
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
EXPERIMENTALThe combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
The standard intervention
ACTIVE COMPARATORThe standard intervention group will receive cervical mobilization and home program (ROM exercises).
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 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 .
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- PRINCIPAL INVESTIGATOR
Everett B Lohman
Loma Linda U
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