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Trial record 3 of 12737 for:    cervical

Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT03165669
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
SOFF-ART S.r.l.
Information provided by (Responsible Party):
Paolo Pillastrini, University of Bologna

Tracking Information
First Submitted Date  ICMJE May 20, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Changes in neck pain over time at 4, 8 and 12 weeks [ Time Frame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) ]
0-100 Numerical Rating Scale for neck, shoulders, thoracic pain, and headache. Frequency of neck, shoulders, thoracic pain, and headache.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03165669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • Changes in neck disability over time at 4, 8 and 12 weeks [ Time Frame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) ]
    Neck Disability Index - Italian version
  • Changes in Global Perceived Effect (GPE) over time at 4 and 12 weeks [ Time Frame: After 4 and 12 weeks from baseline ]
    One question on a 7 points Likert scale
  • Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks [ Time Frame: After 4 and 12 weeks from baseline ]
    One question on a 7 points Likert scale
  • Changes in sleep quality over time at 4, 8 and 12 weeks [ Time Frame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) ]
    Pittsburgh Sleep Quality Index - Italian version
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain
Official Title  ICMJE Randomized, Controlled Clinical Trial With Cross-over on the Efficacy of Cervical Pillows and an Educational Intervention in Patients With Chronic Non-specific Neck Pain
Brief Summary This randomized controlled with cross-over trial aims to investigate the efficacy of a cervical pillow (the "Viscospring PostuRite" made by SOFF-ART S.r.l. Via Maestri del Lavoro 49 - 05100 Terni, Italy) versus education in non-specific chronic neck pain. More specifically, effectiveness will be measured using the following outcome measures: pain, disability, sleep quality, cervical pillow satisfaction, and global perception of the treatment effectiveness.
Detailed Description

The cervical pillow intervention will consist of the delivery and use of a particular cervical pillow ("Viscospring Postural") to be used during nighttime sleep. Each intervention will include an individual meeting with a physical therapist who will explain how to use and maintain the pillow, will last half an hour, and will be supported by the delivery of a user manual. There will be an opportunity to clarify any concerns and to receive answers to questions.

The educational intervention will be conducted by a physical therapist and will consist of advice on proper positions, movements, and activities recommended or not recommended for people with chronic neck pain, both in the workplace and in leisure time, including nighttime postures. Each educational intervention will be carried out individually, will last half an hour, and will be supported by the delivery of an informative brochure. There will be an opportunity to clarify any concerns and to receive answers to questions.

Participants will be required during the duration of the study refrain from modifying the dosage or type of prescribed analgesic or anti-inflammatory drugs they may be taking at the time the study starts and to refrain from initiating new drugs.

Participants will also be required refrain from undertaking any physical therapy or manipulative treatment for neck pain and to pursue their usual activities: work, recreation and physical activity.

Participants will also be required to complete a daily diary of pain for the duration of the study in order to monitor the development of any exclusion criterion during the period of study.

After the administration of the interventions (after 4 weeks of treatment - "Time one"), the first follow-up will be performed, with the administration of these questionnaires: Neck Disability Index (NDI-I), 0-100 Numerical Rating Scale, Pittsburg Sleep Quality Index (PSQI), Global Perceived Effect (GPE), Neck Pillow Satisfaction (NPS).

After four weeks from the " Time one" of the study, another follow-up will be performed, with the administration of the following questionnaires: Neck Disability Index (NDI-I), 0-100 Numerical Rating Scale, Pittsburg Sleep Quality Index (PSQI), and crossover will be performed, which consists in the exchange of treatments between the two groups: the group that did the first intervention will receive the second, and vice versa.

Four weeks after the cross-over, the third follow-up will be performed ("Time three"). In this final phase of the study, these questionnaires will be administrated: Neck Disability Index (NDI-I), 0-100 Numerical Rating Scale, Pittsburg Sleep Quality Index (PSQI), Global Perceived Effect (GPE), Neck Pillow Satisfaction (NPS).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Two groups of patients will be randomized in two parallel arms. At Time zero, the first one will receive education, the second one cervical pillow. After 4 weeks, the 1st follow-up will be done (Time one), and after 4 weeks of wash-out, the 2nd follow-up will be done (Time two). At this moment, the group that received cervical pillow will receive education, and vice versa. After 4 weeks (Time three), the final follow-up will be done.

be done.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

The principal investigator will receive the results of outcome measures without any information of the group assignement.

The outcome assessors will be masked on the group assignment, because they will receive only the list of participants,without the group assignment.

Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • Device: Viscospring PostuRite - "medium" model
    Cervical pillow use, 30-minutes instruction session supported by a brochure
    Other Name: Cervical pillow
  • Other: Education
    30-minutes educational session delivered by a physical therapist and supported by an informative brochure.
Study Arms  ICMJE
  • Experimental: Cervical pillow

    The cervical pillow is known as the Viscospring PostuRite - "medium" model, made by SOFF-ART S.r.l. - Via Maestri del Lavoro 49 - 05100 Terni, Italy. The "Viscospring PostuRite" pillow is externally made of viscoelastic polyurethane and internally 60 independent, individually coated harmonic phosphate-coated steel springs, are thought to promote correct posture of the cervical spine, due to the adaptation of the pillow to the shape and movements of the head.

    Each intervention will be supported by a 30-minutes informative session delivered by a physical therapist, and will be completed by the delivery of an informative brochure.

    Intervention: Device: Viscospring PostuRite - "medium" model
  • Active Comparator: Education
    The educational intervention will be conducted by a physical therapist and will consist of a advice on positions, movements and activities recommended or not recommended for people with chronic neck pain, both in the workplace and in leisure time, including nighttime postures. Each educational intervention will be carried out individually, will last half an hour and will be supported by the delivery of an informative brochure.
    Intervention: Other: Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nonspecific chronic neck pain (neck pain from 3 months or more, not related to specific pathologies);
  • Neck pain, with or without irradiation to the upper limb or to the head, noted as ≥2 on a scale of 0-10;
  • Good comprehension of written and spoken Italian language;
  • Informed consent.

Exclusion Criteria:

  • Acute or sub-acute neck pain;
  • Specific causes of cervical pain (trauma, herniated disc, vertebral deformity, fractures, dislocations);
  • Central or peripheral neurological signs;
  • Systemic pathologies;
  • Rheumatic disorders;
  • Neuromuscular pathologies;
  • Tumors;
  • Cognitive deficits;
  • Surgical interventions in the last six months prior to the study;
  • Physiotherapeutic treatments in the last six months prior to the study;
  • To modify the type or the dosage of analgesic or anti-inflammatory drugs taken at baseline or new drug intakes;
  • Using no pillow or 2 pillows during night time sleep.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03165669
Other Study ID Numbers  ICMJE 1202/2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paolo Pillastrini, University of Bologna
Study Sponsor  ICMJE University of Bologna
Collaborators  ICMJE SOFF-ART S.r.l.
Investigators  ICMJE
Principal Investigator: Paolo Pillastrini University of Bologna
PRS Account University of Bologna
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP