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NCT Number: NCT06886906

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

250 University Blvd

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Kelly M Naugle, PhD

CONTACT

[email protected]

317-274-0601

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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").

  12. 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly M Naugle, PhD

CONTACT

[email protected]

+3172740601

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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