Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03165669
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2017-05-20
Brief Title:
Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Srl 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None