Neck PainNCT03194490

Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain

A study testing combined intervention group and The standard intervention in people with Neck Pain, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Neck Pain
What is being tested?: combined intervention group and The standard intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2016to 8 Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda U
Loma Linda, California, 92354

Other trials in United States

About this study

Read the detailed description

All recruited participants will sign a statement of informed consent. Subjects were randomly divided into two groups (combined intervention group and standard intervention group). The following questionnaires were completed in the following order: Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GROC). Next, Cervical Range of Motion (ROM) and Pain threshold were measured for both groups. The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise). The standard intervention group received cervical mobilization and home program (ROM exercises).

Conditions: Neck Pain
Being tested: combined intervention group, The standard intervention
Medical subject headings: Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

combined intervention groupOther
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 interventionOther
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 .

Study groups in NCT03194490
Study group	Role	What they receive
The combined intervention group	Experimental	The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise). Receives: Other: combined intervention group
The standard intervention	Active comparator	The standard intervention group will receive cervical mobilization and home program (ROM exercises). Receives: Other: The standard intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants ROM measurement at week 8

Secondary outcomes (15)

Numeric Pain Rating Scale
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand. The standard error is correct as stated.
Measured: NPRS score at baseline
Numeric Pain Rating Scale
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
Measured: NPRS score at week two
Numeric Pain Rating Scale
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
Measured: NPRS score at week four
Numeric Pain Rating Scale
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
Measured: NPRS score at week eight
Neck Disability Index
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
Measured: NDI score at baseline
Neck Disability Index
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
Measured: NDI score at week two
Neck Disability Index
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
Measured: NDI score at week four
Neck Disability Index
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
Measured: NDI score at week eight
Global Rating of Change
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively. The points are scores on a scale (-7-0-+7 = 15 point scale).
Measured: GROC score at week two
Global Rating of Change
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.
Measured: GROC score at week four
Global Rating of Change
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.
Measured: GROC score at week eight
Pressure Pain Threshold
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.
Measured: Pressure Pain Threshold score at baseline
Pressure Pain Threshold
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Measured: Pressure Pain Threshold score at week two
Pressure Pain Threshold
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Measured: Pressure Pain Threshold score at week four
Pressure Pain Threshold
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Measured: Pressure Pain Threshold score at week eight

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 20168 Jan 2018

First posted21 Jun 2017
Study start24 Aug 2016
Primary completion8 Jan 2018
Study completion8 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neck PainStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03194490
Sponsor's protocol ID: 5160230
Status last verified: Oct 2019
First submitted: 13 Jun 2017
Last updated: 31 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
ClinicalTrials.gov ID: NCT03194490
Acronym / sponsor ID: 5160230
Conditions: Neck Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 24 Aug 2016 (actual)
Primary completion: 8 Jan 2018 (actual)
Study completion: 8 Jan 2018 (actual)
First posted: 21 Jun 2017 (actual)
Results: Posted 31 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The combined intervention group	Experimental	Other: combined intervention groupThe combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
The standard intervention	Active comparator	Other: The standard interventionThe standard intervention group will receive cervical mobilization and home program (ROM exercises).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
combined intervention groupThe 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.	Other	The combined intervention group
The standard interventionThe 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 .	Other	The standard intervention

Primary outcome

Cervical Range of Motion
Time frame: Participants ROM measurement at baselines
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.
Cervical Range of Motion
Time frame: Participants ROM measurement at week 2
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.
Cervical Range of Motion
Time frame: Participants measurement at week four
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.
Cervical Range of Motion
Time frame: Participants ROM measurement at week 8
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.

15 secondary outcomes

Numeric Pain Rating Scale
Time frame: NPRS score at baseline
Numeric Pain Rating Scale
Time frame: NPRS score at week two
Numeric Pain Rating Scale
Time frame: NPRS score at week four
Numeric Pain Rating Scale
Time frame: NPRS score at week eight
Neck Disability Index
Time frame: NDI score at baseline
Neck Disability Index
Time frame: NDI score at week two
Neck Disability Index
Time frame: NDI score at week four
Neck Disability Index
Time frame: NDI score at week eight
Global Rating of Change
Time frame: GROC score at week two
Global Rating of Change
Time frame: GROC score at week four
Global Rating of Change
Time frame: GROC score at week eight
Pressure Pain Threshold
Time frame: Pressure Pain Threshold score at baseline
Pressure Pain Threshold
Time frame: Pressure Pain Threshold score at week two
Pressure Pain Threshold
Time frame: Pressure Pain Threshold score at week four
Pressure Pain Threshold
Time frame: Pressure Pain Threshold score at week eight

Results and safety

Results posted to the registry on 31 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combined Intervention Group	20	18
The Standard Intervention	23	20

Primary outcome: Cervical Range of Motion

Time frame: Participants ROM measurement at baselines. Mean (Standard Error). Unit: Degree

Measure	Combined Intervention Group n = 18	The Standard Intervention n = 20
Flexion	46.2 (2.6)	46.1 (2.2)
Extesion	71.2 (3.4)	68.5 (2.4)
Right Rotation	65.9 (3.0)	66.1 (2.5)
Left Rotation	60.1 (3.8)	62.7 (2.1)
Right Lateral Flexion	41.8 (2.5)	39.9 (1.9)
Left Lateral Flexion	43.9 (1.9)	42.2 (1.4)

Primary outcome: Cervical Range of Motion

Time frame: Participants ROM measurement at week 2. Mean (Standard Error). Unit: Degree

Measure	Combined Intervention Group n = 18	The Standard Intervention n = 20
Flexion	52.3 (2.4)	49.7 (2.3)
Extesion	77.5 (2.7)	71.1 (3.7)
Right Rotation	71.9 (3.1)	68.6 (2.4)
Left Rotation	66.8 (2.6)	67.8 (2.1)
Right Lateral Flexion	46.3 (1.7)	41.3 (2.0)
Left Lateral Flexion	48.4 (1.6)	44.3 (1.3)

Primary outcome: Cervical Range of Motion

Time frame: Participants measurement at week four. Mean (Standard Error). Unit: Degree

Measure	Combined Intervention Group n = 18	The Standard Intervention n = 20
Flexion	54.9 (2.5)	55.0 (2.3)
Extesion	82.9 (3.1)	70.3 (3.1)
Right Rotation	74.0 (3.4)	74.3 (2.5)
Left Rotation	73.0 (2.2)	70.6 (2.3)
Right Lateral Flexion	50.0 (2.1)	43.6 (1.8)
Left Lateral Flexion	51.6 (2.1)	45.3 (1.6)

Primary outcome: Cervical Range of Motion

Time frame: Participants ROM measurement at week 8. Mean (Standard Error). Unit: Degree

Measure	Combined Intervention Group n = 18	The Standard Intervention n = 20
Flexion	53.9 (2.5)	53.2 (2.6)
Extesion	79.2 (2.8)	74.5 (4.0)
Right Rotation	78.5 (2.5)	71.5 (2.8)
Left Rotation	72.9 (2.4)	71.3 (2.1)
Right Lateral Flexion	51.2 (2.4)	47.3 (1.9)
Left Lateral Flexion	55.3 (2.6)	74.4 (1.9)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: In the combined intervention group, one participant was excluded from the study at week two from base line measurement (second visit). Adverse events in each subject was monitored from baseline through the study completion (e.g., 8-weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Combined Intervention Group	0 of 20 (0%)	1 of 20 (5%)	0 of 20
The Standard Intervention	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): This study had some limitations which they are short follow up period, no control group, and small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Neck Pain

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Everett B Lohman principal investigator

Loma Linda U

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing combined intervention group and The standard intervention in people with Neck Pain, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Range of Motion (time frame: Participants ROM measurement at baselines). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.