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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03194490
Enrollment
43
Registered
2017-06-21
Start date
2016-08-24
Completion date
2018-01-08
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

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

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).

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.

OTHERThe standard intervention

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 .

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Cervical Range of MotionParticipants ROM measurement at baselinesThe 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.

Secondary

MeasureTime frameDescription
Numeric Pain Rating ScaleNPRS score at baselineNumeric 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.
Neck Disability IndexNDI score at baselineNeck 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.
Global Rating of ChangeGROC score at week twoThe 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).
Pressure Pain ThresholdPressure Pain Threshold score at baselinePressure 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
The Combined Intervention Group
The combined intervention group: 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 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 were selected by the physical therapist based on the participant's condition. Stretching exercise will be given to the participants by the physical therapist. 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 muscles and interspinous muscles.
18
The Standard Intervention
The standard intervention: The standard intervention group received 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.
20
Total38

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up13
Overall Studyparticipant developed specific neck pain10

Baseline characteristics

CharacteristicThe Standard InterventionTotalThe Combined Intervention Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants38 Participants18 Participants
Age, Continuous30.6 years
STANDARD_DEVIATION 7.8
31 years
STANDARD_DEVIATION 8.3
31.4 years
STANDARD_DEVIATION 9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants38 Participants18 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
20 participants38 participants18 participants
Sex: Female, Male
Female
12 Participants24 Participants12 Participants
Sex: Female, Male
Male
8 Participants14 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 22
other
Total, other adverse events
1 / 200 / 22
serious
Total, serious adverse events
0 / 200 / 22

Outcome results

Primary

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.

Time frame: Participants measurement at week four

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupCervical Range of MotionFlexion54.9 DegreeStandard Error 2.5
Combined Intervention GroupCervical Range of MotionLeft Rotation73.0 DegreeStandard Error 2.2
Combined Intervention GroupCervical Range of MotionRight Lateral Flexion50.0 DegreeStandard Error 2.1
Combined Intervention GroupCervical Range of MotionExtesion82.9 DegreeStandard Error 3.1
Combined Intervention GroupCervical Range of MotionLeft Lateral Flexion51.6 DegreeStandard Error 2.1
Combined Intervention GroupCervical Range of MotionRight Rotation74.0 DegreeStandard Error 3.4
The Standard InterventionCervical Range of MotionLeft Lateral Flexion45.3 DegreeStandard Error 1.6
The Standard InterventionCervical Range of MotionLeft Rotation70.6 DegreeStandard Error 2.3
The Standard InterventionCervical Range of MotionFlexion55.0 DegreeStandard Error 2.3
The Standard InterventionCervical Range of MotionRight Rotation74.3 DegreeStandard Error 2.5
The Standard InterventionCervical Range of MotionRight Lateral Flexion43.6 DegreeStandard Error 1.8
The Standard InterventionCervical Range of MotionExtesion70.3 DegreeStandard Error 3.1
Primary

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.

Time frame: Participants ROM measurement at week 8

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupCervical Range of MotionFlexion53.9 DegreeStandard Error 2.5
Combined Intervention GroupCervical Range of MotionExtesion79.2 DegreeStandard Error 2.8
Combined Intervention GroupCervical Range of MotionRight Rotation78.5 DegreeStandard Error 2.5
Combined Intervention GroupCervical Range of MotionLeft Rotation72.9 DegreeStandard Error 2.4
Combined Intervention GroupCervical Range of MotionRight Lateral Flexion51.2 DegreeStandard Error 2.4
Combined Intervention GroupCervical Range of MotionLeft Lateral Flexion55.3 DegreeStandard Error 2.6
The Standard InterventionCervical Range of MotionRight Lateral Flexion47.3 DegreeStandard Error 1.9
The Standard InterventionCervical Range of MotionFlexion53.2 DegreeStandard Error 2.6
The Standard InterventionCervical Range of MotionLeft Rotation71.3 DegreeStandard Error 2.1
The Standard InterventionCervical Range of MotionExtesion74.5 DegreeStandard Error 4
The Standard InterventionCervical Range of MotionLeft Lateral Flexion74.4 DegreeStandard Error 1.9
The Standard InterventionCervical Range of MotionRight Rotation71.5 DegreeStandard Error 2.8
Primary

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.

Time frame: Participants ROM measurement at baselines

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupCervical Range of MotionLeft Rotation60.1 DegreeStandard Error 3.8
Combined Intervention GroupCervical Range of MotionFlexion46.2 DegreeStandard Error 2.6
Combined Intervention GroupCervical Range of MotionExtesion71.2 DegreeStandard Error 3.4
Combined Intervention GroupCervical Range of MotionRight Rotation65.9 DegreeStandard Error 3
Combined Intervention GroupCervical Range of MotionRight Lateral Flexion41.8 DegreeStandard Error 2.5
Combined Intervention GroupCervical Range of MotionLeft Lateral Flexion43.9 DegreeStandard Error 1.9
The Standard InterventionCervical Range of MotionRight Lateral Flexion39.9 DegreeStandard Error 1.9
The Standard InterventionCervical Range of MotionLeft Rotation62.7 DegreeStandard Error 2.1
The Standard InterventionCervical Range of MotionRight Rotation66.1 DegreeStandard Error 2.5
The Standard InterventionCervical Range of MotionFlexion46.1 DegreeStandard Error 2.2
The Standard InterventionCervical Range of MotionLeft Lateral Flexion42.2 DegreeStandard Error 1.4
The Standard InterventionCervical Range of MotionExtesion68.5 DegreeStandard Error 2.4
Primary

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.

Time frame: Participants ROM measurement at week 2

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupCervical Range of MotionFlexion52.3 DegreeStandard Error 2.4
Combined Intervention GroupCervical Range of MotionExtesion77.5 DegreeStandard Error 2.7
Combined Intervention GroupCervical Range of MotionRight Rotation71.9 DegreeStandard Error 3.1
Combined Intervention GroupCervical Range of MotionLeft Rotation66.8 DegreeStandard Error 2.6
Combined Intervention GroupCervical Range of MotionRight Lateral Flexion46.3 DegreeStandard Error 1.7
Combined Intervention GroupCervical Range of MotionLeft Lateral Flexion48.4 DegreeStandard Error 1.6
The Standard InterventionCervical Range of MotionRight Lateral Flexion41.3 DegreeStandard Error 2
The Standard InterventionCervical Range of MotionFlexion49.7 DegreeStandard Error 2.3
The Standard InterventionCervical Range of MotionLeft Rotation67.8 DegreeStandard Error 2.1
The Standard InterventionCervical Range of MotionExtesion71.1 DegreeStandard Error 3.7
The Standard InterventionCervical Range of MotionLeft Lateral Flexion44.3 DegreeStandard Error 1.3
The Standard InterventionCervical Range of MotionRight Rotation68.6 DegreeStandard Error 2.4
Secondary

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.

Time frame: GROC score at week eight

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupGlobal Rating of Change4.9 pointsStandard Error 0.6
The Standard InterventionGlobal Rating of Change3.3 pointsStandard Error 1
Secondary

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.

Time frame: GROC score at week four

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupGlobal Rating of Change4.9 pointsStandard Error 0.5
The Standard InterventionGlobal Rating of Change4.5 pointsStandard Error 0.5
Secondary

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).

Time frame: GROC score at week two

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupGlobal Rating of Change2.6 pointsStandard Error 0.5
The Standard InterventionGlobal Rating of Change2.1 pointsStandard Error 0.5
Secondary

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.

Time frame: NDI score at week two

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNeck Disability Index7.2 pointsStandard Error 1
The Standard InterventionNeck Disability Index8.1 pointsStandard Error 0.9
Secondary

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.

Time frame: NDI score at baseline

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNeck Disability Index12.2 pointsStandard Error 1.1
The Standard InterventionNeck Disability Index10.6 pointsStandard Error 1.1
Secondary

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.

Time frame: NDI score at week four

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNeck Disability Index3.8 pointsStandard Error 1.2
The Standard InterventionNeck Disability Index5.1 pointsStandard Error 1.1
Secondary

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.

Time frame: NDI score at week eight

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNeck Disability Index3.7 pointsStandard Error 1
The Standard InterventionNeck Disability Index6.5 pointsStandard Error 2.6
Secondary

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.

Time frame: NPRS score at week four

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNumeric Pain Rating Scale1.7 CmStandard Error 0.4
The Standard InterventionNumeric Pain Rating Scale1.8 CmStandard Error 0.4
Secondary

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.

Time frame: NPRS score at week two

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNumeric Pain Rating Scale3.6 CmStandard Error 0.4
The Standard InterventionNumeric Pain Rating Scale3.0 CmStandard Error 0.4
Secondary

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.

Time frame: NPRS score at week eight

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNumeric Pain Rating Scale1.5 CmStandard Error 0.5
The Standard InterventionNumeric Pain Rating Scale1.8 CmStandard Error 0.6
Secondary

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.

Time frame: NPRS score at baseline

ArmMeasureValue (MEAN)Dispersion
Combined Intervention GroupNumeric Pain Rating Scale5.2 CmStandard Error 0.4
The Standard InterventionNumeric Pain Rating Scale4.3 CmStandard Error 0.4
Secondary

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.

Time frame: Pressure Pain Threshold score at week four

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupPressure Pain ThresholdRight Pressure Pain Threshold5.6 pound per centimeter squareStandard Error 0.5
Combined Intervention GroupPressure Pain ThresholdLeft Pressure Pain Threshold5.8 pound per centimeter squareStandard Error 0.6
The Standard InterventionPressure Pain ThresholdRight Pressure Pain Threshold5.3 pound per centimeter squareStandard Error 0.5
The Standard InterventionPressure Pain ThresholdLeft Pressure Pain Threshold5.6 pound per centimeter squareStandard Error 0.5
Secondary

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.

Time frame: Pressure Pain Threshold score at baseline

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupPressure Pain ThresholdRight Pressure Pain Threshold4.5 pound per centimeter squareStandard Error 0.4
Combined Intervention GroupPressure Pain ThresholdLeft Pressure Pain Threshold4.3 pound per centimeter squareStandard Error 0.4
The Standard InterventionPressure Pain ThresholdRight Pressure Pain Threshold5.0 pound per centimeter squareStandard Error 0.5
The Standard InterventionPressure Pain ThresholdLeft Pressure Pain Threshold4.7 pound per centimeter squareStandard Error 0.4
Secondary

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.

Time frame: Pressure Pain Threshold score at week two

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupPressure Pain ThresholdRight Pressure Pain Threshold4.7 pound per centimeter squareStandard Error 0.3
Combined Intervention GroupPressure Pain ThresholdLeft Pressure Pain Threshold4.5 pound per centimeter squareStandard Error 0.3
The Standard InterventionPressure Pain ThresholdRight Pressure Pain Threshold4.6 pound per centimeter squareStandard Error 0.4
The Standard InterventionPressure Pain ThresholdLeft Pressure Pain Threshold4.5 pound per centimeter squareStandard Error 0.4
Secondary

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.

Time frame: Pressure Pain Threshold score at week eight

ArmMeasureGroupValue (MEAN)Dispersion
Combined Intervention GroupPressure Pain ThresholdRight Pressure Pain Threshold5.8 pound per centimeter squareStandard Error 0.6
Combined Intervention GroupPressure Pain ThresholdLeft Pressure Pain Threshold5.5 pound per centimeter squareStandard Error 0.7
The Standard InterventionPressure Pain ThresholdRight Pressure Pain Threshold4.9 pound per centimeter squareStandard Error 0.4
The Standard InterventionPressure Pain ThresholdLeft Pressure Pain Threshold5.4 pound per centimeter squareStandard Error 0.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026