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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165669
• Other study ID #: 1202/2017
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Device:
• Viscospring PostuRite - "medium" model
Cervical pillow use, 30-minutes instruction session supported by a brochure

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

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna	Emilia Romagna
Italy	University of Bologna	Bologna	Emilia-Romagna

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	SOFF-ART S.r.l.

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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

Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126. — View Citation

Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2004 Dec 7. — View Citation

Lavin RA, Pappagallo M, Kuhlemeier KV. Cervical pain: a comparison of three pillows. Arch Phys Med Rehabil. 1997 Feb;78(2):193-8. — View Citation

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. — View Citation

Persson L, Moritz U. Neck support pillows: a comparative study. J Manipulative Physiol Ther. 1998 May;21(4):237-40. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

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)