Clinical trial NCT03165669: Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: education
sleep
pillow
neck
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: SOFF-ART S.r.l.
First posted: 2017-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in neck pain over time at 4, 8 and 12 weeks
timeFrame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)
Secondary outcomes:
measure: Changes in neck disability over time at 4, 8 and 12 weeks
timeFrame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)
measure: Changes in Global Perceived Effect (GPE) over time at 4 and 12 weeks
timeFrame: After 4 and 12 weeks from baseline
measure: Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks
timeFrame: After 4 and 12 weeks from baseline
measure: Changes in sleep quality over time at 4, 8 and 12 weeks
timeFrame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
state: Emilia Romagna
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia-Romagna
Study officials:
affiliation: University of Bologna
name: Paolo Pillastrini
role: PRINCIPAL_INVESTIGATOR
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