Clinical trial NCT06886906: Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain
Official title: Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older People
Pain
Keywords: physical activity
movement evoked pain
sitting
quantitative sensory testing
musculoskeletal pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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 we will assess medications taken the day of each visit prior to the visit.

Eligibility criteria: 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.

Primary outcomes:
measure: Mechanical Temporal Summation of Pain (TS)
timeFrame: Pre and post the 1-hour experimental conditions
measure: Conditioned Pain Modulation
timeFrame: Pre and post the 1-hour experimental conditions
measure: Movement-evoked pain during the 30-second chair stand test
timeFrame: Will be administered immediately after the 1-hour experimental conditions.
Secondary outcomes:
Other outcomes:
measure: Physical Activity and Sedentary Behavior Questionnaire (PASB-Q)
timeFrame: At baseline during one of the study sessions
measure: The Physical Activity Scale for the Elderly (PASE)
timeFrame: At baseline during one of the study sessions
measure: Movement evoked pain during the six minute walk test
timeFrame: At baseline during each study session.
measure: Graded Chronic Pain Scale (GCPS)
timeFrame: At baseline during one of the study sessions
measure: Pain Catastrophizing Scale (PCS)
timeFrame: At baseline during one of the study sessions
measure: Short-Form Health Survey-36 (SF-36)
timeFrame: At baseline during one of the study sessions
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: At baseline during one of the study sessions
measure: Pain Disability Index (PDI)
timeFrame: At baseline during one of the study sessions
measure: Anatomical map for locating pain areas
timeFrame: At baseline during one of the study sessions
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline during one of the study sessions
measure: Adult Hope Scale (AHS)
timeFrame: At baseline during one of the study sessions
measure: Ratings of perceived exertion (RPE)
timeFrame: During the intermittent bouts of walking during the walking experimental condition
Locations:
city: Indianapolis
country: United States
facility: 250 University Blvd
state: Indiana
Study officials:
affiliation: School of Health and Human Sciences, IUPUI
name: Kelly Marie Naugle
role: PRINCIPAL_INVESTIGATOR
References: