Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain

NCT03165669 | Completed

• 1 other identifier: 1202/2017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Keywords

education; sleep; pillow; neck

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Changes in Global Perceived Effect (GPE) over time at 4 and 12 weeks

  After 4 and 12 weeks from baseline

• Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks

  After 4 and 12 weeks from baseline

• 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)

Study Arms (2)

Cervical pillow

EXPERIMENTAL

The cervical pillow is known as the Viscospring PostuRite - "medium" model, made by SOFF-ART S.r.l. - Via Maestri del Lavoro 49 - 05100 Terni, Italy. The "Viscospring PostuRite" pillow is externally made of viscoelastic polyurethane and internally 60 independent, individually coated harmonic phosphate-coated steel springs, are thought to promote correct posture of the cervical spine, due to the adaptation of the pillow to the shape and movements of the head. Each intervention will be supported by a 30-minutes informative session delivered by a physical therapist, and will be completed by the delivery of an informative brochure.

Device: Viscospring PostuRite - "medium" model

Education

ACTIVE COMPARATOR

The educational intervention will be conducted by a physical therapist and will consist of a advice on 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.

Other: Education

Interventions

Viscospring PostuRite - "medium" model DEVICE

Cervical pillow use, 30-minutes instruction session supported by a brochure

Also known as: Cervical pillow

Cervical pillow

Education OTHER

30-minutes educational session delivered by a physical therapist and supported by an informative brochure.

Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead
• SOFF-ART S.r.l.: collaborator

Study Sites (2)

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (17)

• Castro-Martin E, Ortiz-Comino L, Gallart-Aragon 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.

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• Domingo AR, Diek M, Goble KM, Maluf KS, Goble DJ, Baweja HS. Short-duration therapeutic massage reduces postural upper trapezius muscle activity. Neuroreport. 2017 Jan 18;28(2):108-110. doi: 10.1097/WNR.0000000000000718.

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• Erfanian P, Tenzif S, Guerriero RC. Assessing effects of a semi-customized experimental cervical pillow on symptomatic adults with chronic neck pain with and without headache. J Can Chiropr Assoc. 2004 Mar;48(1):20-8.

  PMID: 17549216 BACKGROUND

• Gordon SJ, Grimmer-Somers K, Trott P. Pillow use: the behaviour of cervical pain, sleep quality and pillow comfort in side sleepers. Man Ther. 2009 Dec;14(6):671-8. doi: 10.1016/j.math.2009.02.006. Epub 2009 May 7.

  PMID: 19427257 BACKGROUND

• Hagino C, Boscariol J, Dover L, Letendre R, Wicks M. Before/after study to determine the effectiveness of the align-right cylindrical cervical pillow in reducing chronic neck pain severity. J Manipulative Physiol Ther. 1998 Feb;21(2):89-93.

  PMID: 9502063 BACKGROUND

• Haines T, Gross AR, Burnie S, Goldsmith CH, Perry L, Graham N; Cervical Overview Group (COG). A Cochrane review of patient education for neck pain. Spine J. 2009 Oct;9(10):859-71. doi: 10.1016/j.spinee.2009.04.019. Epub 2009 Jul 12.

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• Helewa A, Goldsmith CH, Smythe HA, Lee P, Obright K, Stitt L. Effect of therapeutic exercise and sleeping neck support on patients with chronic neck pain: a randomized clinical trial. J Rheumatol. 2007 Jan;34(1):151-8.

  PMID: 17216683 BACKGROUND

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• Monticone M, Ferrante S, Vernon H, Rocca B, Dal Farra F, Foti C. Development of the Italian Version of the Neck Disability Index: cross-cultural adaptation, factor analysis, reliability, validity, and sensitivity to change. Spine (Phila Pa 1976). 2012 Aug 1;37(17):E1038-44. doi: 10.1097/BRS.0b013e3182579795.

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• Klaber Moffett JA, Jackson DA, Richmond S, Hahn S, Coulton S, Farrin A, Manca A, Torgerson DJ. Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference. BMJ. 2005 Jan 8;330(7482):75. doi: 10.1136/bmj.38286.493206.82. Epub 2004 Dec 7.

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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.

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• Wegner S, Jull G, O'Leary S, Johnston V. The effect of a scapular postural correction strategy on trapezius activity in patients with neck pain. Man Ther. 2010 Dec;15(6):562-6. doi: 10.1016/j.math.2010.06.006. Epub 2010 Jul 21.

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• Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25.

  PMID: 19632904 BACKGROUND

• Vanti C, Banchelli F, Marino C, Puccetti A, Guccione AA, Pillastrini P. Effectiveness of a "Spring Pillow" Versus Education in Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. Phys Ther. 2019 Sep 1;99(9):1177-1188. doi: 10.1093/ptj/pzz056.

  PMID: 30939188 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Paolo Pillastrini

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore ordinario

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: May 24, 2017
• Study Start: June 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: July 31, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)