Effectiveness Study of an Exercise Program for Older Adults With Chronic Musculoskeletal Pain

A Comparative Study of Two Different Physical Exercise Programs to Improve Pain, Functional Status, and Physical Performance in Older Adults With Chronic Musculoskeletal Pain: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate the effectiveness of a multimodal physical exercise program for older adults (> 60 years) with chronic musculoskeletal pain. The main question it aims to answer is:

What is the impact of the intervention program on participants´ pain intensity (primary outcome), function, physical performance, and somatosensory function (secondary outcomes)? Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (10 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program to be carried out over a period of 10 weeks at a frequency of twice a week.

Study Overview

• Status: Completed
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Other: Physical exercise program; Other: Neural mobilization techniques

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3810-193
    • Department of Medical Sciences (University of Aveiro), Campus Universitário de Santiago, Agra do Crasto, Edifício 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Community-dwelling older adults aged 60 years or older
• People with primary or secondary chronic musculoskeletal pain in any body site
• People able to walk independently

Exclusion Criteria:

• Individuals undergoing surgery in the last 3 months
• Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, stroke, uncontrolled diabetes, or at high risk of developing cardiovascular events
• Those with physical limitations that make it impossible for them to carry out the intervention protocols independently (e.g., wheelchair user)
• Patients who are receiving another physical therapy intervention to treat their pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical exercise	Other: Physical exercise program; The physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises.
Experimental: Physical exercise + Neural mobilization	Other: Physical exercise program; The physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises.; Other: Neural mobilization techniques; Neural mobilization techniques for the upper and lower quadrants will be actively performed by participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	Brief Pain Inventory - It assesses pain intensity and functional interference related to pain in the last week. In addition to these two main aspects, it also evaluates the location of the pain, the use of medications and the amount of pain relief in the last week. The instrument has 4 items relating to pain intensity in the last week and 7 items relating to the functional interference of pain with numerical rating scales (from 0 to 10) where higher values indicate greater pain severity. In situations where the participant reports musculoskeletal pain in more than one site, they will be asked to answer the questions considering their main chronic pain.	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal characteristics of pain	World Health Organization (WHO) Classification - It is a categorical variable with three different possible response categories: (1) Episodic recurrent pain - recurrent pain attacks with pain-free intervals; (2) Continuous pain - pain is always present; (3) Continuous with pain attacks (recurrent pain flare-ups as exacerbations of ongoing underlying pain).	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Neuropathic pain components	painDETECT questionnaire - The instrument consists of 4 sections related to: (1) pain intensity in the last 4 weeks; (2) the pain pattern; (3) regions of pain; and (4) presence of neuropathic descriptors. The total score is obtained by adding the scores of the last 3 sections and can vary from 1 to 38. Scores ≤ 12 = the neuropathic mechanism is very unlikely to be present (predominance of the nociceptive mechanism); Scores ≥ 19 = there is a high probability of a predominant neuropathic mechanism; Scores > 12 and < 19 = the presence of a mixed component.	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Pain Catastrophizing	Pain Catastrophizing Scale (PCS) - The instrument has 13 items subdivided into three different subscales: helplessness (items 1, 2, 3, 4, 5, and 12); magnification (items 6, 7, and 13); and rumination (items 8, 9, 10, and 11). All subscales are evaluated on a 5-point Likert scale, from 0 (not at all) to 4 (all the time), where higher scores represent a greater level of catastrophizing.	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Fear of Movement	Tampa Scale for Kinesiophobia - The instrument comprises 13 items rated on a 4-point Likert scale, as follows: (1) strongly disagree; (2) somewhat disagree; (3) somewhat agree; (4) strongly agree. The higher the score, the greater the fear perceived during the execution of the movement.	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Pressure Pain Threshold measured in three different sites (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)	Algometer	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Lower Limb Strength	Five Times Sit to Stand Test	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Grip Strength	Hand-held dynamometer	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Balance	Functional Reach Test	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Signs and symptoms of hypersensitivity of the nervous system	Central Sensitization Inventory (CSI) - It assesses common symptoms and facilitating factors for hypersensitivity of the nervous system in 25 items. The patient scores each response on a scale from 0 (never) to 4 (always). The final score is obtained by summing the scores of the individual items and can range from 0 to 100, where higher scores mean a worse outcome.	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Q-sense - Cold and Warm Perception Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)	It will be assessed using a portable quantitative sensory testing device capable of assessing peripheral sensory nerve function using hot and cold thermal sensory thresholds (Q-sense, Medoc).	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Q-sense - Heat Pain Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)	It will be assessed using a portable quantitative sensory testing device capable of assessing peripheral sensory nerve function (Q-sense, Medoc).	T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physiotherapy; Older adults; Exercise program; Chronic musculoskeletal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: RCT2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No