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

9 oktober 2019 bijgewerkt door: Everett Lohman, Loma Linda University
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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

43

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Loma Linda, California, Verenigde Staten, 92354
        • Loma Linda U

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
Ander: 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 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.
Actieve vergelijker: The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
Ander: The 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 .

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cervical Range of Motion
Tijdsspanne: 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.
Participants ROM measurement at baselines
Cervical Range of Motion
Tijdsspanne: 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.
Participants ROM measurement at week 2
Cervical Range of Motion
Tijdsspanne: 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.
Participants measurement at week four
Cervical Range of Motion
Tijdsspanne: 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.
Participants ROM measurement at week 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Numeric Pain Rating Scale
Tijdsspanne: 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.
NPRS score at baseline
Numeric Pain Rating Scale
Tijdsspanne: 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.
NPRS score at week two
Numeric Pain Rating Scale
Tijdsspanne: 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.
NPRS score at week four
Numeric Pain Rating Scale
Tijdsspanne: 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.
NPRS score at week eight
Neck Disability Index
Tijdsspanne: 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.
NDI score at baseline
Neck Disability Index
Tijdsspanne: 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.
NDI score at week two
Neck Disability Index
Tijdsspanne: 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.
NDI score at week four
Neck Disability Index
Tijdsspanne: 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.
NDI score at week eight
Global Rating of Change
Tijdsspanne: 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).
GROC score at week two
Global Rating of Change
Tijdsspanne: 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.
GROC score at week four
Global Rating of Change
Tijdsspanne: 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.
GROC score at week eight
Pressure Pain Threshold
Tijdsspanne: 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.
Pressure Pain Threshold score at baseline
Pressure Pain Threshold
Tijdsspanne: 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.
Pressure Pain Threshold score at week two
Pressure Pain Threshold
Tijdsspanne: 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.
Pressure Pain Threshold score at week four
Pressure Pain Threshold
Tijdsspanne: 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.
Pressure Pain Threshold score at week eight

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Loma Linda University

Onderzoekers

  • Hoofdonderzoeker: Everett B Lohman, Loma Linda U

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 augustus 2016

Primaire voltooiing (Werkelijk)

8 januari 2018

Studie voltooiing (Werkelijk)

8 januari 2018

Studieregistratiedata

Eerst ingediend

13 juni 2017

Eerst ingediend dat voldeed aan de QC-criteria

20 juni 2017

Eerst geplaatst (Werkelijk)

21 juni 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

9 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 5160230

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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