Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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).
    

Intervention name(s): Viscospring PostuRite - "medium" model; Education
Intervention type(s): Device; Other
Intervention description(s): Cervical pillow use, 30-minutes instruction session supported by a brochure; 30-minutes educational session delivered by a physical therapist and supported by an informative brochure.
Other intervention name(s): Cervical pillow
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)
Primary purpose: Treatment
Keywords: education; sleep; pillow; neck