Neck PainSCAPELNCT05175443
Surgeons Can Avoid Lasting Pain Through Exercise Literacy
A study testing Exercise in people with Neck Pain and Shoulder Pain, run by Timothy Uhl at 1 site in United States.
Trial summary
The physical demands of surgery are in many ways similar to those of high-performance athletes. No professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Shoulder Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 31 Dec 2022
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be an actively operating surgeon either faculty, fellow, or resident.
- Must report at least 4 out of 10 with pain at worst over the previous week at intake that is attributed to operating.
Who cannot join
- Participants will be excluded if they have prior neck or upper back surgery within the last year.
- If the participant has any other medical condition that would prevent the participant from performing shoulder and neck strengthening and stretching exercises.
Trial locations and contacts
1 site in 1 country.
About this study
The physical demands of surgery are in many ways similar to those of high-performance athletes. No professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to their work demands. A series of exercises were developed to help stretch and strengthen the key core muscles to support surgeons during operating to prevent neck pain. This study hypothesizes that Neck pain discomfort will decrease following an 8-week intervention program compared to baseline reported scores.
Read the detailed description
Participant will be asked to fill out a series 5 questionnaires at beginning of the study, end of the 8-week intervention and 1 month later to determine how the exercise program affected their general health, neck pain, and function.
- Demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items)
- A questionnaire about neck pain (10 items)
- A questionnaire about how pain interferes with their life (8 items)
- A questionnaire about general health (10 items)
- A questionnaire about how much the participant typically exercise. (4 items) All these questionnaires can be completed on a computer or tablet and the data will be stored on a secure site (RedCap). This should be completed in approximately 20 minutes at each assessment.
Next participants will be instructed how to perform a series of 4 exercises described in the intervention
Every week the participant will be sent a 3-item questionnaire to report their level of pain, surgical burden, and exercise compliance for the week. There are only 3 multiple choice questions which should take approximately 1 minute to complete per week.
- Conditions
- Neck Pain, Shoulder Pain
- Being tested
- Exercise
- Keywords
- Surgeon
- Medical subject headings
- Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will be trained, by a physical therapist, to perform a set of four daily exercises requiring 1 sets of 2 minutes for each exercise totaling 8 minutes of targeted exercise per day for 8 weeks of the intervention. These exercises will be progressed or modified every 2-4 weeks to assure the participant is receiving maximal benefit for their exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 1. Wall Angels:Stretching tight anterior shoulder musculature Participants will assume this position and slide their arms up and down the wall for 2 minutes.
2. Cervical Spine Mobility: will be accomplished by having the participant stabilize their shoulders and side bend their head in various positions to stretch each side of their next for 2 minutes with 10-15 second holds in each position.
3. Posterior shoulder strengthening: will be performed with shoulder externally rotating and squeezing the scapular with 5 second holds for 2 minutes.
4. Thoracic Spinal mobility: to improve thoracic extension participants will use a strap or tennis ball and perform thoracic extension with 10 second holds for 2 minutes. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index
The Neck Disability Index is 10 items, with each item consisting of likert type scale ranging from 0-4 with a lower score indicating less disability. The 10 items are summed for a total of potential 50 points which is then normalized to 100% scale by multiplying by 2.
Measured: Baseline, at end of 8 weeks of intervention
Secondary outcomes (1)
Worse Neck Pain
Numeric pain rating scale of worse pain for the week in the neck. Scale ranges from 0=no pain to 10=worst pain imaginable
Measured: Baseline, at end of 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start8 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated Measure
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Uhl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Uhl, University of Kentucky
- Investigators
- Tim L Uhl, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175443
- Sponsor's protocol ID
- 72626
- Acronym
- SCAPEL
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alhusuny A, Cook M, Khalil A, Xie Y, Johnston V. Neck/Shoulder Problems and Visual Disturbances Among Surgeons: A Scoping Review. J Surg Res. 2020 Mar;247:413-428. doi: 10.1016/j.jss.2019.09.064. Epub 2019 Oct 31.
PubMed 31679800Daher A, Carel RS, Tzipi K, Esther H, Dar G. The effectiveness of an aerobic exercise training on patients with neck pain during a short- and long-term follow-up: a prospective double-blind randomized controlled trial. Clin Rehabil. 2020 May;34(5):617-629. doi: 10.1177/0269215520912000. Epub 2020 Mar 17.
PubMed 32183555Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
PubMed 1834753Cleland 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 18164333Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeons Can Avoid Lasting Pain Through Exercise Literacy
- ClinicalTrials.gov ID
- NCT05175443
- Acronym / sponsor ID
- SCAPEL / 72626
- Conditions
- Neck Pain, Shoulder Pain
- Keywords
- Surgeon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Timothy UhlUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Jan 2022 (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.
The physical demands of surgery are in many ways similar to those of high-performance athletes. No professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to their work demands. A series of exercises were developed to help stretch and strengthen the key core muscles to support surgeons during operating to prevent neck pain. This study hypothesizes that Neck pain discomfort will decrease following an 8-week intervention program compared to baseline reported scores.
Detailed description
Participant will be asked to fill out a series 5 questionnaires at beginning of the study, end of the 8-week intervention and 1 month later to determine how the exercise program affected their general health, neck pain, and function.
- Demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items)
- A questionnaire about neck pain (10 items)
- A questionnaire about how pain interferes with their life (8 items)
- A questionnaire about general health (10 items)
- A questionnaire about how much the participant typically exercise. (4 items) All these questionnaires can be completed on a computer or tablet and the data will be stored on a secure site (RedCap). This should be completed in approximately 20 minutes at each assessment.
Next participants will be instructed how to perform a series of 4 exercises described in the intervention
Every week the participant will be sent a 3-item questionnaire to report their level of pain, surgical burden, and exercise compliance for the week. There are only 3 multiple choice questions which should take approximately 1 minute to complete per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated Measure
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Exercise1. Wall Angels:Stretching tight anterior shoulder musculature Participants will assume this position and slide their arms up and down the wall for 2 minutes. 2. Cervical Spine Mobility: will be accomplished by having the participant stabilize their shoulders and side bend their head in various positions to stretch each side of their next for 2 minutes with 10-15 second holds in each position. 3. Posterior shoulder strengthening: will be performed with shoulder externally rotating and squeezing the scapular with 5 second holds for 2 minutes. 4. Thoracic Spinal mobility: to improve thoracic extension participants will use a strap or tennis ball and perform thoracic extension with 10 second holds for 2 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be an actively operating surgeon either faculty, fellow, or resident.
- Must report at least 4 out of 10 with pain at worst over the previous week at intake that is attributed to operating.
Key exclusion criteria (2 listed)
- Participants will be excluded if they have prior neck or upper back surgery within the last year.
- If the participant has any other medical condition that would prevent the participant from performing shoulder and neck strengthening and stretching exercises.
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 |
|---|---|---|
| ExerciseParticipants will be trained, by a physical therapist, to perform a set of four daily exercises requiring 1 sets of 2 minutes for each exercise totaling 8 minutes of targeted exercise per day for 8 weeks of the intervention. These exercises will be progressed or modified every 2-4 weeks to assure the participant is receiving maximal benefit for their exercise intervention. | Other | Exercise Intervention |
Primary outcome
Change in Neck Disability Index
Time frame: Baseline, at end of 8 weeks of intervention
The Neck Disability Index is 10 items, with each item consisting of likert type scale ranging from 0-4 with a lower score indicating less disability. The 10 items are summed for a total of potential 50 points which is then normalized to 100% scale by multiplying by 2.
1 secondary outcome
Worse Neck Pain
Time frame: Baseline, at end of 8 weeks of intervention
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 25 Jan 2023.
- Background: PubMed 31679800Alhusuny A, Cook M, Khalil A, Xie Y, Johnston V. Neck/Shoulder Problems and Visual Disturbances Among Surgeons: A Scoping Review. J Surg Res. 2020 Mar;247:413-428. doi: 10.1016/j.jss.2019.09.064. Epub 2019 Oct 31.
- Background: PubMed 32183555Daher A, Carel RS, Tzipi K, Esther H, Dar G. The effectiveness of an aerobic exercise training on patients with neck pain during a short- and long-term follow-up: a prospective double-blind randomized controlled trial. Clin Rehabil. 2020 May;34(5):617-629. doi: 10.1177/0269215520912000. Epub 2020 Mar 17.
- Background: PubMed 1834753Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
- 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 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- 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.
Tim L Uhl, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neck Pain and Shoulder Pain, run by Timothy Uhl at 1 site 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 2 inclusion and 2 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 25 Jan 2023. 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 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 Disability Index (time frame: Baseline, at end of 8 weeks of intervention). 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 NCT05175443, which also lists 5 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 25 Jan 2023.