NCT06465394

Brief Summary

Exercised induced hypoalgesia (EIH) (reduction in pain) after exercise has been studied in the literature, but no comparisons have been made specifically looking at different types of exercise (isometric/dynamic moving through a range of motion with resistance versus isotonic/applying static resistance to a joint not moving) with neck muscle strengthening. This study will explore to see if one form of exercise is superior to the other in providing EIH. Another benefit of exercise is improving proprioception (knowing where our body is in space). Again no specific investigation has been done comparing isometric versus isotonic exercises for neck muscles. Both of these exercises are often prescribed in physical therapy so further understanding the benefits of them can help improve the prescription of exercises for patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

June 10, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • PPT

    Pain Pressure Threshold with use of algometer

    Pre post measure before and after exercise session taking approximately 10 minutes

Secondary Outcomes (1)

  • JPE

    Pre post measure before and after exercise session taking approximately 10 minutes

Study Arms (2)

Isometric Exercise

ACTIVE COMPARATOR

Isometric test protocol. Participants will be asked to perform the exercise at a moderate exercise level (3/10 on the mRPE scale provided to them). They will complete a 1, 10-second isometric hold to their hand dominant side (if ambidextrous, the side the participant would report as the most dominant side) to allow them to find their "moderate" intensity level. The participant will then take a 2-minute rest before beginning the exercise routine and will be instructed to keep a consistent resistance level during the exercise bout. During the exercise, the subjects will hold the rotation contraction for 10 seconds, take a 2-second rest, complete this 5 times, and then change to the left side. They will do this for 3 sets of right and left. Researchers will time the exercises and give verbal instructions to make sure they are performing for the appropriate amount of time and rest periods.

Procedure: Exercise

Isotonic Exercise

ACTIVE COMPARATOR

The resistance level will stay at the participant's selected moderate level during the entire testing unless they need to stop due to pain or difficulty completing the exercise. During the exercise, the participants will be rotating to the right first at a pace of 1 second for concentric contraction to full rotation and 1 second for eccentric contraction, returning the head to the neutral position. The participant will continue this pace to complete 5 repetitions and then take a 2-second rest before continuing this sequence 5 times (a total of 25 reps) before switching and doing left rotation in the same fashion. This will be done for a total of 3 sets for both right and left rotation. The use of a metronome will be used along with the researcher's verbal instructions and cueing to maintain the proper sequence and timing of the exercise.

Procedure: Exercise

Interventions

ExercisePROCEDURE

Neck exercises in a cross over design that the participants will do both types of interventions with a washout period inbetween.

Isometric ExerciseIsotonic Exercise

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old,
  • all genders,
  • healthy individuals with no neck pain

You may not qualify if:

  • Medical restrictions to physical activity
  • History of chronic pain (pain \> 3 months) or current acute neck pain
  • Unable to refrain from alcohol, pain medications, and vigorous exercise 24 hours prior to testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Dakota

Vermillion, South Dakota, 57069, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kory J Zimney, PhD

    University of South Dakota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kory J Zimney, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 18, 2024

Study Start

August 12, 2024

Primary Completion

December 20, 2024

Study Completion

May 5, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations