Surgeons Can Avoid Lasting Pain Through Exercise Literacy (SCAPEL)

January 22, 2023 updated by: Timothy Uhl
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

  1. Demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items)
  2. A questionnaire about neck pain (10 items)
  3. A questionnaire about how pain interferes with their life (8 items)
  4. A questionnaire about general health (10 items)
  5. 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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention
  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.
Other: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, at end of 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worse Neck Pain
Time Frame: Baseline, at end of 8 weeks of intervention
Numeric pain rating scale of worse pain for the week in the neck. Scale ranges from 0=no pain to 10=worst pain imaginable
Baseline, at end of 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy Uhl

Investigators

  • Principal Investigator: Tim L Uhl, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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