NCT05851586

Brief Summary

The main purpose of our study is to assess whether guided strength training and stretching intervention with a written home exercise program is more effective than a home exercise program alone for pre-clinical dental students in improving and preventing pain associated with dental laboratory practice. Secondary aims will be to assess relationships between strength and quality of life measures of an individual and pain levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

April 20, 2023

Last Update Submit

September 24, 2025

Conditions

Keywords

Dental studentsSupervised exerciseHome exercise programStrengthQuality of life

Outcome Measures

Primary Outcomes (6)

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

    PROMIS® is a publicly available system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. This will be measured via electronic survey.

    Baseline

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

    PROMIS® is a publicly available system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. This will be measured via electronic survey.

    Intervention conclusion (7 months)

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

    PROMIS® is a publicly available system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. This will be measured via electronic survey.

    11 months

  • Pain Intensity

    Visual analog scale (0-10 rating)

    Baseline

  • Pain Intensity

    Visual analog scale (0-10 rating)

    Intervention conclusion (7 months)

  • Pain Intensity

    Visual analog scale (0-10 rating)

    11 months

Secondary Outcomes (12)

  • Pec Minor Length Test

    Baseline, intervention conclusion (7 months), and 4 month follow up prior to beginning clinical rotations.

  • Pec Minor Length Test

    Intervention conclusion (7 months)

  • Pec Minor Length Test

    11 months

  • Middle Trapezius Manual Muscle Test

    Baseline

  • Middle Trapezius Manual Muscle Test

    Intervention conclusion (7 months)

  • +7 more secondary outcomes

Study Arms (2)

Supervised exercise + home exercise program

EXPERIMENTAL

The intervention group (supervised exercise) which will receive supervised strengthening and stretching exercises by a licensed physical therapist in a group setting 2 times per month for 30 minutes each session as well as a home exercise program with general stretching and strengthening exercises for various body parts (focusing on neck, thoracic spine, lumbar spine, shoulder and hand/wrist) that will be identical to the home exercise program only group.

Procedure: Supervised exercise + home exercise program

Home exercise program only

ACTIVE COMPARATOR

The home exercise program only group will be provided with a written home exercise program consisting of general stretching and strengthening exercises for various body parts (focusing on neck, thoracic spine, lumbar spine, shoulder and hand/wrist). The exercise programs will be identical for both the supervised exericse and the home exercise program only groups.

Procedure: Home exercise program only

Interventions

The supervised exercise + home exercise program group will receive a written home exercise program with general stretching and strengthening exercises for the neck, thoracic spine, lumbar spine, shoulder and hand/wrist. They will also be provided with two supervised exercise sessions per month delivered in a group setting in order to ensure proper performance of the home exercise programs.

Supervised exercise + home exercise program

The home exercise program only group will receive a written home exercise program with general stretching and strengthening exercises for the neck, thoracic spine, lumbar spine, shoulder and hand/wrist, without any supervised guidance on exercise performance.

Home exercise program only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ages 18+
  • Current 2nd year university dental students

You may not qualify if:

  • Any type of musculoskeletal surgery in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwestern University

Glendale, Arizona, 85308, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lacey Frankland, DPT

    Midwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Associate Investigator

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 9, 2023

Study Start

September 1, 2023

Primary Completion

August 12, 2024

Study Completion

August 12, 2024

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations