Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain

April 14, 2026 updated by: Kelly Naugle, PhD, Indiana University
The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to determine whether exposure to acute sitting compared to sitting interrupted with brief bouts of light intensity walking exerts short term effects on resting pain, endogenous pain modulation measured via quantitative sensory testing (QST), and movement-evoked pain (MEP) in older adults. Participants will be asked to complete two study sessions, with the first study session lasting 3 hours and the second study session lasting 2.5 hours. All sessions will take place in the National Institute of Sport Fitness, where the Physical Activity and Pain laboratory is located. The first session will include the following procedures in the following order: informed consent process, healthy history for screening purposes, quantitative sensory testing (QST), 6-minute walk test, completion of questionnaires, QST, experimental conditions of either 1 hour of sitting or 1 hour of sitting with bouts of light intensity walking, QST, and the 30-second chair stand test. Session 2 will take place at least 7 days after session 1 and will be identical except for the informed consent and screening will be replaced by questionnaires and the experimental condition will consist of the one not performed in session 1. Participants will be asked to take their medications at the same time prior to each study visit and the investigators will assess medications taken the day of each visit prior to the visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kelly M Naugle, PhD
  • Phone Number: +3172740601
  • Email: kmnaugle@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • 250 University Blvd
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Community-dwelling men and women
  • Answer yes to the following question: Have you experienced any musculoskeletal pain (pain affecting joints, bones, ligaments, tendons or muscles) in the past month?

Exclusion Criteria:

  • Cardiovascular issues such as uncontrolled blood pressure over 150/99 mmHg, heart failure, or history of acute myocardial infarction;
  • Angina in the last month (squeezing, pressure, heaviness, tightness, or pain in chest)
  • Serious systemic disease or condition (e.g., severe osteoarthritis, injury) that restricts normal daily activities
  • Neurological disease (e.g., Parkinson's Disease, multiple sclerosis, epilepsy)
  • Serious psychiatric conditions (schizophrenia, bipolar disorder) or hospitalization within the preceding year for psychiatric illness
  • Known peripheral neuropathy
  • Chronic opioid use (defined as ≥ 90 days)
  • Unable to walk for 6 minutes without assistive devices

Session exclusion criteria:

• Participants will be asked to not participate in vigorous or unaccustomed exercise 48 hours prior to each study session.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Uninterrupted Sitting for 1 hour
The participant will remain seated throughout the experimental period and will be instructed to minimize excessive movement, only rising from the chair to void. This experimental condition is designed to mimic prolonged uninterrupted sedentary behavior.
Behavioral: uninterrupted sitting
The participant will remain seated throughout the experimental period and will be instructed to minimize excessive movement, only rising from the chair to void. This experimental condition is designed to mimic prolonged uninterrupted sedentary behavior.
Experimental: 1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking
Participants will sit as described above with six bouts of 2.5-minutes of light intensity walking (see Figure 2). Overall, the bouts will occur on six occasions, providing a total of 15 minutes of light intensity activity. Participants will be asked to walk at a light intensity based on the 6-20 RPE scale, which corresponds to a 9-11 RPE rating. This experimental condition is designed to mimic sedentary behavior interspersed with frequent short bouts of LPA. RPE and pain intensity (0-100 scale) will be assessed at the end of each walking bout.
Behavioral: Intermittent light walking
The participant will remain seated throughout the 1 hour experimental period. During this 1-hour period, participants will complete six bouts of 2.5-minutes of light intensity walking. Overall, the bouts will occur on six occasions, providing a total of 15 minutes of light intensity activity.
Other Names:
  • 1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mechanical Temporal Summation of Pain (TS)
Time Frame: Pre and post the 1-hour experimental conditions
TS will be administered on the back of the left hand. First, a single pinprick stimulus using a von Frey filament of 6.65 Mn or 300 g will be applied to the body site. Participants will rate the perceived pain intensity using a numeric rating scale of 0 (no pain at all) to 100 (worst pain imaginable). Then, a series of 10 pinprick stimuli (6.65 Mn) will be administered at a rate of 1 Hz, applied to the body site within an area of 1 cm2. The temporal summation value will be calculated as the difference between the first and last stimuli.
Pre and post the 1-hour experimental conditions
Conditioned Pain Modulation
Time Frame: Pre and post the 1-hour experimental conditions
CPM will be assessed by determining the ability of a cold water bath (conditioning stimulus) to diminish pressure pain thresholds (PPTs) and temporal summation (TS) (test stimuli) applied at a separate body site. For the CPM trials, PPTs and TS will be measured pre and post a conditioning stimulus. Conditioning stimulus: At least 4 minutes will separate the pre pain assessments (i.e., PPT, TS) and the initiation of the conditioning stimulation, during which subjects will sit quietly. Then, participants will immerse their right hand up to the wrist in a cold water bath maintained at 10oC for up to 1 minute or until they report intolerable pain. The dependent variable for the CPM test will be the change in the test stimuli (PPT and TS) following the conditioning stimulus.
Pre and post the 1-hour experimental conditions
Movement-evoked pain during the 30-second chair stand test
Time Frame: Will be administered immediately after the 1-hour experimental conditions.
This test will be administered using a folding chair without arms, placed against a wall to prevent it from moving during the test. The test begins with the subject seated in the middle of the chair, feet at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance when standing. Arms will be crossed at the wrists and held against the chest. At the signal of "go", subjects will rise to a full stand and then return back to the initial position. The subjects will be encouraged to complete as many full stands as possible within a 30-s time limit. Participants will rate their current bodily pain on a 0 to 10 numeric rating scale (NRS), with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Participants will rate their bodily pain before, during, and after the chair stand test as a measure of movement evoked pain.
Will be administered immediately after the 1-hour experimental conditions.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Activity and Sedentary Behavior Questionnaire (PASB-Q)
Time Frame: At baseline during one of the study sessions
The PASB-Q has 7 items to measure reported aerobic PA, muscle strengthening PA, perceived aerobic fitness, and sedentary behavior.
At baseline during one of the study sessions
The Physical Activity Scale for the Elderly (PASE)
Time Frame: At baseline during one of the study sessions
The PASE has a total of 18 items using a 4-point scales and yes/no questions. The items capture seven dimensions of physical activity. People with higher scores are more physically active.
At baseline during one of the study sessions
Movement evoked pain during the six minute walk test
Time Frame: At baseline during each study session.
Subjects will be required to walk as far as possible at their usual pace in 6 minutes around a predetermined indoor walking course on a flat surface. The distance subjects cover will be recorded. Participants will rate their current bodily pain on a 0 to 10 numeric rating scale (NRS), with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Participants will rate their bodily pain before, during, and after the walk as a measure of movement evoked pain.
At baseline during each study session.
Graded Chronic Pain Scale (GCPS)
Time Frame: At baseline during one of the study sessions
The GCPS will be used to measure pain-related severity and disability across 7-items
At baseline during one of the study sessions
Pain Catastrophizing Scale (PCS)
Time Frame: At baseline during one of the study sessions
The PCS asks the respondents to reflect upon past painful experiences and to rate the degree to which they experienced negative thoughts or feelings about pain. Catastrophizing is a multidimensional construct composed of rumination, helplessness, and magnification.
At baseline during one of the study sessions
Short-Form Health Survey-36 (SF-36)
Time Frame: At baseline during one of the study sessions
The SF-36 is a health survey that yields 8-scale scores (physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perceptions, social functioning, role limitations due to emotional problems, and mental health).
At baseline during one of the study sessions
Tampa Scale of Kinesiophobia (TSK)
Time Frame: At baseline during one of the study sessions
The TSK consists of 11 items and is rated on a 4-point scale. The TSK is used to measure the fear of movement or re-injury. The TSK has been deemed a valid and reliable method for determining fear of movement in both clinical and nonclinical populations.
At baseline during one of the study sessions
Pain Disability Index (PDI)
Time Frame: At baseline during one of the study sessions
The PDI is a simple and rapid 7-item instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities.
At baseline during one of the study sessions
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline during one of the study sessions
The PSQI is a self-report questionnaire used to assess sleep quality and quantity over the last month. The PSQI includes 19 items to measure seven domains of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, daytime dysfunction, sleep disturbance and use of sleeping medications.
At baseline during one of the study sessions
Adult Hope Scale (AHS)
Time Frame: At baseline during one of the study sessions
AHS is a measure of trait hope in adults formed from agency and pathways thinking. The AHS includes 12 statements that participants rate from 1 (definitely false) to 8 (definitely true) for how the statements describe them. (e.g., "I can think of many ways in life to get the things that are most important to me").
At baseline during one of the study sessions
Ratings of perceived exertion (RPE)
Time Frame: During the intermittent bouts of walking during the walking experimental condition
Subjects will rate their perception of exertion while walking using Borg's RPE scale. This rating should reflect how heavy and strenuous the exercise feels, combining all sensations and feeling of physical stress, effort, and fatigue. The scale ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion."
During the intermittent bouts of walking during the walking experimental condition
Anatomical map for locating pain areas
Time Frame: At baseline during one of the study sessions
An anatomical map for locating pain areas that is part of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) will be used.
At baseline during one of the study sessions

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kelly Marie Naugle, School of Health and Human Sciences, IUPUI

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24426

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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