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Completed

NCT Number: NCT03194490

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

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

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda U

Loma Linda, California, 92354, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Intervention Group

Other

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

Other

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 .

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: NPRS score at baseline

    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.

  2. Numeric Pain Rating Scale

    Time frame: NPRS score at week two

    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.

  3. Numeric Pain Rating Scale

    Time frame: NPRS score at week four

    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.

  4. Numeric Pain Rating Scale

    Time frame: NPRS score at week eight

    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.

  5. Neck Disability Index

    Time frame: NDI score at baseline

    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.

  6. Neck Disability Index

    Time frame: NDI score at week two

    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.

  7. Neck Disability Index

    Time frame: NDI score at week four

    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.

  8. Neck Disability Index

    Time frame: NDI score at week eight

    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.

  9. Global Rating of Change

    Time frame: GROC score at week two

    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).

  10. Global Rating of Change

    Time frame: GROC score at week four

    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.

  11. Global Rating of Change

    Time frame: GROC score at week eight

    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.

  12. Pressure Pain Threshold

    Time frame: Pressure Pain Threshold score at baseline

    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.

  13. Pressure Pain Threshold

    Time frame: Pressure Pain Threshold score at week two

    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.

  14. Pressure Pain Threshold

    Time frame: Pressure Pain Threshold score at week four

    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.

  15. Pressure Pain Threshold

    Time frame: Pressure Pain Threshold score at week eight

    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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2017
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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