Neck PainNCT02451267
Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
A study testing physical therapy treatment with aerobic exercise and physical therapy treatment in people with Neck Pain, run by Clalit Health Services at 1 site in Israel.
Trial summary
The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- physical therapy treatment with aerobic exercise and physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to Mar 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic neck pain (> 30 days)
- neck disability index >10
- not physical active on a daily basis
Who cannot join
- past history of whiplash injury or cervical surgery
- pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength)
- complain of vertigo
- cervical spine diseases: Spondylosis, Spondylolisthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.
Read the detailed description
Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment.
Aims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel.
Study Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of "Clalit Health Services" in Haifa and Western Galilee area.
Participants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP.
Methods: Following a baseline examination in which the subjects' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney's paper (e.g.: neck disability Index score < 18/50 ,shoulder protraction, cervical side bending < 32°,Fear avoidance belief questionnaire-physical activity score < 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points.
The baseline examination will include: active and passive cervical range of motion, neurological exam (reflex, sensation, muscle testing), cervical segmental mobility (accessory movement), neck muscle length, cervical manual muscle test and posture assessment.
The research group will receive neck exercise program with neck massage and AE (leg bicycling with relaxed shoulders) and the control group will receive neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. Immediate examination will be used at the last treatment (10 treatments), and at 3 and 6 month follow up examination for long-term effects.
In addition, Data collecting from physiotherapy department in "Clalit Health Services" about statistic of patients with NP who referred to physical therapy including: Prevalence, demographic and profile data
- Conditions
- Neck Pain
- Being tested
- physical therapy treatment with aerobic exercise, physical therapy treatment
- Keywords
- neck pain, aerobic exercise, cervical pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy treatment with aerobic exerciseOther
neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)
physical therapy treatmentOther
neck exercise strengthening program with neck massage
| Study group | Role | What they receive |
|---|---|---|
| positive CPR: research group | Experimental | physical therapy treatment with aerobic exercise Receives: Other: physical therapy treatment with aerobic exercise |
| negative CPR: research group | Experimental | physical therapy treatment with aerobic exercise Receives: Other: physical therapy treatment with aerobic exercise |
| positive CPR: control group | Active comparator | physical therapy treatment Receives: Other: physical therapy treatment |
| negative CPR: control group | Active comparator | physical therapy treatment Receives: Other: physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change (GROC) scale
rating pain severity on a scale from -7 to 7
Measured: following 6 weeks of treatment, 3 months and 6 months
Secondary outcomes (8)
Change from baseline in Neck Disability Index at 6 weeks
Questionnaire assessing the individuals disability due to the neck pain
Measured: following 6 weeks of treatment
Change from baseline in Fear Avoidance Beliefs Questionnaire
Questionnaire about the individuals fear that his pain is caused due to movement or work
Measured: following 6 weeks of treatment
Change from baseline in cervical range of motion
active range of motion using inclinometer
Measured: following 6 weeks of treatment
long term follow up assessment of VAS
phone assessment of cervical pain severity
Measured: 3 months and 6 months
long term follow up assessment Neck Disability Index
phone assessment of individuals disability
Measured: 3 months and 6 months
Change from baseline in Visual Analog Scale (VAS) at 6 weeks
rating pain severity on a scale from 0-10
Measured: following 6 weeks of treatment
headache complaints
complains of headache episodes
Measured: following 6 weeks of treatment, 3 months and 6 months
medication consumption for pain relief
how many medication the patient used
Measured: following 6 weeks of treatment, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Prof. Refael Carel, Clalit Health Services
- Investigators
- Gali Dar, PhD, Study director, University of Haifa, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451267
- Sponsor's protocol ID
- COM-0016-15
- Status last verified
- Mar 2019
- First submitted
- 10 May 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76.
PubMed 24377062Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trondelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159.
PubMed 19046448Daher A, Dar G, Carel R. Effectiveness of combined aerobic exercise and neck-specific exercise compared to neck-specific exercise alone on work ability in neck pain patients: a secondary analysis of data from a randomized controlled trial. Int Arch Occup Environ Health. 2021 Oct;94(7):1739-1750. doi: 10.1007/s00420-021-01684-0. Epub 2021 Mar 17.
PubMed 33730206
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
- ClinicalTrials.gov ID
- NCT02451267
- Acronym / sponsor ID
- COM-0016-15
- Conditions
- Neck Pain
- Keywords
- neck pain, aerobic exercise, cervical pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- 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.
The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.
Detailed description
Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment.
Aims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel.
Study Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of "Clalit Health Services" in Haifa and Western Galilee area.
Participants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP.
Methods: Following a baseline examination in which the subjects' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney's paper (e.g.: neck disability Index score < 18/50 ,shoulder protraction, cervical side bending < 32°,Fear avoidance belief questionnaire-physical activity score < 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points.
The baseline examination will include: active and passive cervical range of motion, neurological exam (reflex, sensation, muscle testing), cervical segmental mobility (accessory movement), neck muscle length, cervical manual muscle test and posture assessment.
The research group will receive neck exercise program with neck massage and AE (leg bicycling with relaxed shoulders) and the control group will receive neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. Immediate examination will be used at the last treatment (10 treatments), and at 3 and 6 month follow up examination for long-term effects.
In addition, Data collecting from physiotherapy department in "Clalit Health Services" about statistic of patients with NP who referred to physical therapy including: Prevalence, demographic and profile data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| positive CPR: research group | Experimental | Other: physical therapy treatment with aerobic exercisephysical therapy treatment with aerobic exercise |
| negative CPR: research group | Experimental | Other: physical therapy treatment with aerobic exercisephysical therapy treatment with aerobic exercise |
| positive CPR: control group | Active comparator | Other: physical therapy treatmentphysical therapy treatment |
| negative CPR: control group | Active comparator | Other: physical therapy treatmentphysical therapy treatment |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic neck pain (> 30 days)
- neck disability index >10
- not physical active on a daily basis
Key exclusion criteria (4 listed)
- past history of whiplash injury or cervical surgery
- pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength)
- complain of vertigo
- cervical spine diseases: Spondylosis, Spondylolisthesis
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 |
|---|---|---|
| physical therapy treatment with aerobic exerciseneck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) | Other | negative CPR: research group, positive CPR: research group |
| physical therapy treatmentneck exercise strengthening program with neck massage | Other | negative CPR: control group, positive CPR: control group |
Primary outcome
Global Rating of Change (GROC) scale
Time frame: following 6 weeks of treatment, 3 months and 6 months
rating pain severity on a scale from -7 to 7
8 secondary outcomes
Change from baseline in Neck Disability Index at 6 weeks
Time frame: following 6 weeks of treatment
Change from baseline in Fear Avoidance Beliefs Questionnaire
Time frame: following 6 weeks of treatment
Change from baseline in cervical range of motion
Time frame: following 6 weeks of treatment
long term follow up assessment of VAS
Time frame: 3 months and 6 months
long term follow up assessment Neck Disability Index
Time frame: 3 months and 6 months
Change from baseline in Visual Analog Scale (VAS) at 6 weeks
Time frame: following 6 weeks of treatment
headache complaints
Time frame: following 6 weeks of treatment, 3 months and 6 months
medication consumption for pain relief
Time frame: following 6 weeks of treatment, 3 months and 6 months
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 13 Mar 2019.
- Background: PubMed 24377062Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76.
- Background: PubMed 19046448Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trondelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159.
- Derived from this study: PubMed 33730206Daher A, Dar G, Carel R. Effectiveness of combined aerobic exercise and neck-specific exercise compared to neck-specific exercise alone on work ability in neck pain patients: a secondary analysis of data from a randomized controlled trial. Int Arch Occup Environ Health. 2021 Oct;94(7):1739-1750. doi: 10.1007/s00420-021-01684-0. Epub 2021 Mar 17.
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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.
Gali Dar, PhD study director
University of Haifa, Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy treatment with aerobic exercise and physical therapy treatment in people with Neck Pain, run by Clalit Health Services at 1 site in Israel.
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 3 inclusion and 4 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Global Rating of Change (GROC) scale (time frame: following 6 weeks of treatment, 3 months and 6 months). 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 NCT02451267, which also lists 3 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 13 Mar 2019.