Neck Pain
Conditions
Keywords
education, sleep, pillow, neck
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).
Interventions
DEVICEViscospring PostuRite - medium model
Cervical pillow use, 30-minutes instruction session supported by a brochure
OTHEREducation
30-minutes educational session delivered by a physical therapist and supported by an informative brochure.
Sponsors
SOFF-ART S.r.l.
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neck pain over time at 4, 8 and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neck disability over time at 4, 8 and 12 weeks | 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 | 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 | 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 | At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) | Pittsburgh Sleep Quality Index - Italian version |
Countries
Italy
Outcome results
None listed