Neck PainNCT03165669
Evaluation of the Efficacy of Cervical Pillows in Subjects With Non-specific Chronic Neck Pain
A study testing Viscospring PostuRite - "medium" model and Education in people with Neck Pain, run by University of Bologna at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Viscospring PostuRite - "medium" model and Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
University of Bologna
Bologna, Emilia-Romagna, 40138
About this study
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
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.
Read the 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).
- Conditions
- Neck Pain
- Being tested
- Viscospring PostuRite - "medium" model, Education
- Keywords
- education, sleep, pillow, neck
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscospring PostuRite - "medium" modelDevice
Also called Cervical pillow
Cervical pillow use, 30-minutes instruction session supported by a brochure
EducationOther
30-minutes educational session delivered by a physical therapist and supported by an informative brochure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Neck Disability Index - Italian version
Measured: 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
One question on a 7 points Likert scale
Measured: After 4 and 12 weeks from baseline
Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks
One question on a 7 points Likert scale
Measured: After 4 and 12 weeks from baseline
Changes in sleep quality over time at 4, 8 and 12 weeks
Pittsburgh Sleep Quality Index - Italian version
Measured: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jun 2017
- Primary completion31 Oct 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- SOFF-ART S.r.l.
- Responsible party
- Principal investigator, Paolo Pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165669
- Sponsor's protocol ID
- 1202/2017
- Status last verified
- Aug 2018
- First submitted
- 20 May 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28003133Cleland 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.
PubMed 18164333Curcio 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.
PubMed 22526760Domingo 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.
PubMed 27977513Erfanian 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.
PubMed 17549216Gordon 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.
PubMed 19427257Hagino 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.
PubMed 9502063Haines 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.
PubMed 19596214Helewa 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.
PubMed 17216683Lavin RA, Pappagallo M, Kuhlemeier KV. Cervical pain: a comparison of three pillows. Arch Phys Med Rehabil. 1997 Feb;78(2):193-8. doi: 10.1016/s0003-9993(97)90263-x.
PubMed 9041902Monticone 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.
PubMed 22487712Klaber 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.
PubMed 15585539Persson L, Moritz U. Neck support pillows: a comparative study. J Manipulative Physiol Ther. 1998 May;21(4):237-40.
PubMed 9608378Sacco 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.
PubMed 26209581Wegner 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.
PubMed 20663706
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03165669
- Acronym / sponsor ID
- 1202/2017
- Conditions
- Neck Pain
- Keywords
- education, sleep, pillow, neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- SOFF-ART S.r.l.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cervical pillow | Experimental | Device: Viscospring PostuRite - "medium" modelThe 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. |
| Education | Active comparator | Other: EducationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viscospring PostuRite - "medium" modelAlso: Cervical pillowCervical pillow use, 30-minutes instruction session supported by a brochure | Device | Cervical pillow |
| Education30-minutes educational session delivered by a physical therapist and supported by an informative brochure. | Other | Education |
Primary outcome
Changes in neck pain over time at 4, 8 and 12 weeks
Time frame: At baseline, and at 3 follow-ups (after 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.
4 secondary outcomes
Changes in neck disability over time at 4, 8 and 12 weeks
Time frame: 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
Time frame: After 4 and 12 weeks from baseline
Changes in Neck Pillow Satisfaction (NPS) over time at 4 and 12 weeks
Time frame: After 4 and 12 weeks from baseline
Changes in sleep quality over time at 4, 8 and 12 weeks
Time frame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Background: PubMed 28003133Castro-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.
- Background: PubMed 18164333Cleland 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.
- Background: PubMed 22526760Curcio 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.
- Background: PubMed 27977513Domingo 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.
- Background: PubMed 17549216Erfanian 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.
- Background: PubMed 19427257Gordon 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.
- Background: PubMed 9502063Hagino 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.
- Background: PubMed 19596214Haines 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.
- Background: PubMed 17216683Helewa 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.
- Background: PubMed 9041902Lavin RA, Pappagallo M, Kuhlemeier KV. Cervical pain: a comparison of three pillows. Arch Phys Med Rehabil. 1997 Feb;78(2):193-8. doi: 10.1016/s0003-9993(97)90263-x.
- Background: PubMed 22487712Monticone 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.
- Background: PubMed 15585539Klaber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pillastrini principal investigator
University of Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viscospring PostuRite - "medium" model and Education in people with Neck Pain, run by University of Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neck pain over time at 4, 8 and 12 weeks (time frame: At baseline, and at 3 follow-ups (after 4, 8, and 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165669, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.