Neck PainNCT04334655
Effects of Physical Therapy on Isometric Neck Retraction Strength and Pain in Patients With Neck Disability
An observational study of Neck Pain and Strength, run by Campbell University, Incorporated at 4 sites in United States.
Trial summary
Impaired neck muscle strength is related to neck pain, abnormal posture, and various cervical pathologies. Clinicians, therefore require objective, reliable and valid methods for quantifying neck strength. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Physical Therapy
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2020to 23 Oct 2021
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with neck pain receiving physical therapy
Who may be able to join
- 18 years of age or older Primary complaints of neck pain and receiving Physical Therapy
Who cannot join
- History of neck surgery Neurologic diseases Chronic Obstructive Pulmonary Disease (COPD)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Performance PT
Cos Cob, Connecticut, 06807
Integral Physical Therapy
Firestone, Colorado, 80504
Connecticut Physical Therapy Specialists
Granby, Connecticut, 06035
Back in Action
Holly Springs, North Carolina, 27540
About this study
Impaired neck muscle strength is related to neck pain, abnormal posture, and various cervical pathologies. Clinicians, therefore require objective, reliable and valid methods for quantifying neck strength. In a previous study, the investigators developed a novel, valid, and reliable method for measuring neck retraction strength, using a handheld dynamometer (HHD), in normal, healthy individuals. The investigators are now expanding this research to study a patient population. Specifically, to describe isometric neck retraction strength in patients with neck pain and to study the effects of physical therapy (PT) on that strength. Our hypothesis is that isometric cervical retraction strength will increase over the course of treatment and that there will be an inverse relationship between strength and the Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI).
Read the detailed description
Four physical therapists from four different outpatient clinics will collect demographic, anthropomorphic, and isometric neck retraction strength data with an HHD in patients with primary complaints of neck pain at the time of the initial evaluation, regular follow-ups, and at discharge. The PT will also include a shortlist of the primary interventions used during the course of treatment. A short video explaining how to test isometric neck retraction strength will be provided to each clinic and the description can also be found in the investigator's previous article entitled "Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer." Basically, the patient will lay on their back with the HHD under the external occipital protuberance. The patient will then perform a practice isometric contraction at 50% maximum force followed by two maximum effort trials with 1-minute in-between.
A follow-up phone call will be made to each clinic to assure that the units arrived and to answer any additional questions regarding the procedure or data to be collected. Follow up phone calls will then be performed monthly to assess progress. At the end of three months, a preliminary analysis, based on the total number of documented patients will be made. A power analysis indicates that 40 patients will be sufficient to answer our research question. This is based on a 2007 article by Cagnie, B. in the Archives of Physical Medicine Rehabilitation entitled "Differences in isometric neck muscle strength between healthy controls and women with chronic neck pain: the use of a reliable measurement." To account for drop-outs the investigators raised this to an n=60.
Data will be collected over a secure Qualtrics server to which each participating PT will have an individual access code. No identifiable patient information will be given to the investigators. Data analysis will include Pearson or Spearman correlation coefficients to examine the relationship between isometric neck strength with patient-reported outcome measures including the Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI). Repeat Measure ANOVA will be used to compare the variables including strength over different time frames throughout the episode of care. An intention to treat analysis will be used for patients who do not complete the study or their Physical Therapy (PT) care.
Data will be collected on 60 consecutive patients with neck pain. Inclusion criteria include patients over the age of 18 years that are receiving physical therapy with primary complaints of neck pain. Exclusion criteria include individuals with a history of cervical neck surgery as well as those with neurologic diseases or Chronic Obstructive Pulmonary Disease (COPD).
Day 1: Patient with a primary complaint of neck pain is seen in one of the four physical therapy clinics participating in the study. The patient is recruited by the PT in the clinic. The study will be explained to the patient and written consent obtained and filed in the clinic. A copy of the consent will also be given to the participant.
The PT conducts their initial evaluation and treatment as they normally would with the addition of a test for isometric neck strength. Measuring neck strength is a normal procedure for a PT to perform and is well within the scope of practice for physical therapists. Many clinics do not have hand-held dynamometers (HHD) so we will be providing the dynamometers and mailing them to each clinic. The MicroFET2 hand-held dynamometer is FDA approved (Regulation number: 21 CFR 888.1240) and will be used only in the manner for which it was attended, i.e. to measure isometric strength. The hand-held dynamometer is placed in a cradle behind the patient's head in supine. Instructions are given to retract the chin and head into the dynamometer three times. 1 practice trial at 50% and 2 maximum effort trials with 1 minute between attempts. This is outlined in the investigator's 2019 study (Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer. Journal of Manual and Manipulative Therapy. 2019;27(4): 222-228.) The entire procedure will take approximately 5 minutes. This information is recorded along with anthropomorphic data, pain levels, neck disability index, and treatment performed. All information is coded and sent to the primary researchers over a secure Qualtrics connection.
- The patient will receive regular Physical Therapy care. The neck strength, pain, and neck disability index are recorded at re-assessments (usually monthly) and at discharge. The use of this assessment will in no way impact the quality or quantity of PT received by the patient.
- Being tested
- Physical Therapy
- Keywords
- Neck Pain, Strength, Physical Therapy
- 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 TherapyOther
Also called Rehabilitation, Neck Strengthening
Patients with primary complaints of neck pain will receive routine physical therapy care including modalities, manual therapy including neck mobilization and manipulation, stretching and strengthening exercises, and patient education.
| Study group | Role | What they receive |
|---|---|---|
| Clinic 1 | Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. Receives: Other: Physical Therapy | |
| Clinic 2 | Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. Receives: Other: Physical Therapy | |
| Clinic 3 | Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. Receives: Other: Physical Therapy | |
| Clinic 4 | Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Retraction Strength
Change in isometric Neck Retraction Strength measured with a Hoggan MicroFET2 hand-held dynamometer in kilograms at baseline, approximately every 30 days during the physical therapy intervention and immediately after the physical therapy intervention at discharge. The estimated period of time from baseline until completion is 3 months.
Measured: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated period of time from baseline until completion is 3 months.
Secondary outcomes (2)
Change in Neck Pain: Numeric Pain Rating Scale (NPRS)
Change in subjective reports of neck pain on the Numeric Pain Rating Scale (NPRS) will be recorded by the physical therapist for each subject on a 0 - 10 point scale with "0" being no pain and "10" being extreme pain or the worst pain imaginable. The pain level will be recorded at baseline, approximately every 30 days during the physical therapy intervention, and immediately after the physical therapy intervention at discharge. The estimated time frame from baseline until completion is 3 months.
Measured: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 months.
Function
Change in Neck Disability Index (NDI) Score. The Neck Disability Index is a patient reported outcome measure that will be completed by each participant at baseline, approximately every 30 days during the physical therapy intervention and immediately after the physical therapy intervention at discharge. The questionnaire is reported as a percentage (%) with higher scores indicating higher levels of disability. The estimated time frame from baseline until completion is 3 months.
Measured: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Mar 2020
- Primary completion23 Oct 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell University, Incorporated
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Tudini, Campbell University, Incorporated
- Investigators
- Frank Tudini, DSc, Principal investigator, Campbell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334655
- Sponsor's protocol ID
- CampbellU
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be de-identified in each clinic and then shared with the primary investigator at Campbell University. The de-identified data will be available after data analysis is performed.
Publications
Tudini F, Myers B, Bohannon R. Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer. J Man Manip Ther. 2019 Sep;27(4):222-228. doi: 10.1080/10669817.2019.1586167. Epub 2019 Mar 18.
PubMed 30935321Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Differences in isometric neck muscle strength between healthy controls and women with chronic neck pain: the use of a reliable measurement. Arch Phys Med Rehabil. 2007 Nov;88(11):1441-5. doi: 10.1016/j.apmr.2007.06.776.
PubMed 17964885
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Isometric Neck Retraction Strength and Pain in Patients With Neck Disability
- ClinicalTrials.gov ID
- NCT04334655
- Acronym / sponsor ID
- CampbellU
- Keywords
- Neck Pain, Strength, Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Campbell University, IncorporatedUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 6 Apr 2020 (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.
Impaired neck muscle strength is related to neck pain, abnormal posture, and various cervical pathologies. Clinicians, therefore require objective, reliable and valid methods for quantifying neck strength. In a previous study, the investigators developed a novel, valid, and reliable method for measuring neck retraction strength, using a handheld dynamometer (HHD), in normal, healthy individuals. The investigators are now expanding this research to study a patient population. Specifically, to describe isometric neck retraction strength in patients with neck pain and to study the effects of physical therapy (PT) on that strength. Our hypothesis is that isometric cervical retraction strength will increase over the course of treatment and that there will be an inverse relationship between strength and the Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI).
Detailed description
Four physical therapists from four different outpatient clinics will collect demographic, anthropomorphic, and isometric neck retraction strength data with an HHD in patients with primary complaints of neck pain at the time of the initial evaluation, regular follow-ups, and at discharge. The PT will also include a shortlist of the primary interventions used during the course of treatment. A short video explaining how to test isometric neck retraction strength will be provided to each clinic and the description can also be found in the investigator's previous article entitled "Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer." Basically, the patient will lay on their back with the HHD under the external occipital protuberance. The patient will then perform a practice isometric contraction at 50% maximum force followed by two maximum effort trials with 1-minute in-between.
A follow-up phone call will be made to each clinic to assure that the units arrived and to answer any additional questions regarding the procedure or data to be collected. Follow up phone calls will then be performed monthly to assess progress. At the end of three months, a preliminary analysis, based on the total number of documented patients will be made. A power analysis indicates that 40 patients will be sufficient to answer our research question. This is based on a 2007 article by Cagnie, B. in the Archives of Physical Medicine Rehabilitation entitled "Differences in isometric neck muscle strength between healthy controls and women with chronic neck pain: the use of a reliable measurement." To account for drop-outs the investigators raised this to an n=60.
Data will be collected over a secure Qualtrics server to which each participating PT will have an individual access code. No identifiable patient information will be given to the investigators. Data analysis will include Pearson or Spearman correlation coefficients to examine the relationship between isometric neck strength with patient-reported outcome measures including the Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI). Repeat Measure ANOVA will be used to compare the variables including strength over different time frames throughout the episode of care. An intention to treat analysis will be used for patients who do not complete the study or their Physical Therapy (PT) care.
Data will be collected on 60 consecutive patients with neck pain. Inclusion criteria include patients over the age of 18 years that are receiving physical therapy with primary complaints of neck pain. Exclusion criteria include individuals with a history of cervical neck surgery as well as those with neurologic diseases or Chronic Obstructive Pulmonary Disease (COPD).
Day 1: Patient with a primary complaint of neck pain is seen in one of the four physical therapy clinics participating in the study. The patient is recruited by the PT in the clinic. The study will be explained to the patient and written consent obtained and filed in the clinic. A copy of the consent will also be given to the participant.
The PT conducts their initial evaluation and treatment as they normally would with the addition of a test for isometric neck strength. Measuring neck strength is a normal procedure for a PT to perform and is well within the scope of practice for physical therapists. Many clinics do not have hand-held dynamometers (HHD) so we will be providing the dynamometers and mailing them to each clinic. The MicroFET2 hand-held dynamometer is FDA approved (Regulation number: 21 CFR 888.1240) and will be used only in the manner for which it was attended, i.e. to measure isometric strength. The hand-held dynamometer is placed in a cradle behind the patient's head in supine. Instructions are given to retract the chin and head into the dynamometer three times. 1 practice trial at 50% and 2 maximum effort trials with 1 minute between attempts. This is outlined in the investigator's 2019 study (Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer. Journal of Manual and Manipulative Therapy. 2019;27(4): 222-228.) The entire procedure will take approximately 5 minutes. This information is recorded along with anthropomorphic data, pain levels, neck disability index, and treatment performed. All information is coded and sent to the primary researchers over a secure Qualtrics connection.
- The patient will receive regular Physical Therapy care. The neck strength, pain, and neck disability index are recorded at re-assessments (usually monthly) and at discharge. The use of this assessment will in no way impact the quality or quantity of PT received by the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinic 1 | – | Other: Physical TherapyClinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. |
| Clinic 2 | – | Other: Physical TherapyClinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. |
| Clinic 3 | – | Other: Physical TherapyClinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. |
| Clinic 4 | – | Other: Physical TherapyClinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with neck pain receiving physical therapy
Key inclusion criteria (1 listed)
- 18 years of age or older Primary complaints of neck pain and receiving Physical Therapy
Key exclusion criteria (1 listed)
- History of neck surgery Neurologic diseases Chronic Obstructive Pulmonary Disease (COPD)
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 TherapyAlso: Rehabilitation, Neck StrengtheningPatients with primary complaints of neck pain will receive routine physical therapy care including modalities, manual therapy including neck mobilization and manipulation, stretching and strengthening exercises, and patient education. | Other | Clinic 1, Clinic 2, Clinic 3, Clinic 4 |
Primary outcome
Change in Neck Retraction Strength
Time frame: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated period of time from baseline until completion is 3 months.
Change in isometric Neck Retraction Strength measured with a Hoggan MicroFET2 hand-held dynamometer in kilograms at baseline, approximately every 30 days during the physical therapy intervention and immediately after the physical therapy intervention at discharge. The estimated period of time from baseline until completion is 3 months.
2 secondary outcomes
Change in Neck Pain: Numeric Pain Rating Scale (NPRS)
Time frame: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 months.
Function
Time frame: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 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 2 May 2022.
- Results publication: PubMed 30935321Tudini F, Myers B, Bohannon R. Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer. J Man Manip Ther. 2019 Sep;27(4):222-228. doi: 10.1080/10669817.2019.1586167. Epub 2019 Mar 18.
- Results publication: PubMed 17964885Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Differences in isometric neck muscle strength between healthy controls and women with chronic neck pain: the use of a reliable measurement. Arch Phys Med Rehabil. 2007 Nov;88(11):1441-5. doi: 10.1016/j.apmr.2007.06.776.
- Individual participant dataSharing planned: Undecided. Data will be de-identified in each clinic and then shared with the primary investigator at Campbell University. The de-identified data will be available after data analysis is performed.
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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.
Frank Tudini, DSc principal investigator
Campbell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Strength, run by Campbell University, Incorporated at 4 sites in United States.
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 1 inclusion and 1 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Change in Neck Retraction Strength (time frame: At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated period of time from baseline until completion is 3 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 NCT04334655, which also lists 2 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 2 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.