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

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: Recruiting
• Conditions: Pain; Older People
• Intervention / Treatment: Behavioral: uninterrupted sitting; Behavioral: Intermittent light walking

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Kelly M Naugle, PhD; Phone Number: 317-274-0601; Email: kmnaugle@iu.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mechanical Temporal Summation of Pain (TS)	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	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	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

Outcome Measure	Measure Description	Time Frame
Physical Activity and Sedentary Behavior Questionnaire (PASB-Q)	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)	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	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)	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)	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)	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)	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)	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)	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)	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)	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	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

• Sponsor: Indiana University
• Investigators: Principal Investigator: Kelly Marie Naugle, School of Health and Human Sciences, IUPUI

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; quantitative sensory testing; musculoskeletal pain; sitting; movement evoked pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Musculoskeletal Pain; Motor Activity
• Other Study ID 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