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

NCT06886906 | Recruiting

• 1 other identifier: 24426
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older People; Pain

Keywords

physical activity; movement evoked pain; sitting; quantitative sensory testing; musculoskeletal pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Physical Activity and Sedentary Behavior Questionnaire (PASB-Q)

  At baseline during one of the study sessions

• The Physical Activity Scale for the Elderly (PASE)

  At baseline during one of the study sessions

• Movement evoked pain during the six minute walk test

  At baseline during each study session.

Study Arms (2)

Uninterrupted Sitting for 1 hour

EXPERIMENTAL

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

1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

EXPERIMENTAL

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

Interventions

Intermittent light walking BEHAVIORAL

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.

Also known as: 1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

uninterrupted sitting BEHAVIORAL

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.

Uninterrupted Sitting for 1 hour

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

250 University Blvd

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Pain; Motor Activity; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Kelly Marie Naugle

  School of Health and Human Sciences, IUPUI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly M Naugle, PhD

CONTACT

+3172740601; kmnaugle@iu.edu

Study Design

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

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)