Neck Pain Clinical Trial
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
NCT number | NCT03165669 |
Other study ID # | 1202/2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | July 31, 2018 |
Verified date | August 2018 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 31, 2018 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico S.Orsola-Malpighi | Bologna | Emilia Romagna |
Italy | University of Bologna | Bologna | Emilia-Romagna |
Lead Sponsor | Collaborator |
---|---|
University of Bologna | SOFF-ART S.r.l. |
Italy,
Castro-Martín E, Ortiz-Comino L, Gallart-Aragón T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18. — View Citation
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Sacco IC, Pereira IL, Dinato RC, Silva VC, Friso B, Viterbo SF. The effect of pillow height on muscle activity of the neck and mid-upper back and patient perception of comfort. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):375-81. doi: 10.1016/j.jmpt.2015.06.012. Epub 2015 Jul 21. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in neck pain over time at 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. | At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) | |
Secondary | Changes in neck disability over time at 4, 8 and 12 weeks | Neck Disability Index - Italian version | At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) | |
Secondary | Changes in Global Perceived Effect (GPE) over time at 4 and 12 weeks | One question on a 7 points Likert scale | After 4 and 12 weeks from baseline | |
Secondary | Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks | One question on a 7 points Likert scale | After 4 and 12 weeks from baseline | |
Secondary | Changes in sleep quality over time at 4, 8 and 12 weeks | Pittsburgh Sleep Quality Index - Italian version | At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks) |
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