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Completed

NCT Number: NCT06138314

A Pilot Study of a Neural Mobilization Intervention Applied to Older Adults With Chronic Musculoskeletal Pain

The goal of this pilot study is to evaluate the feasibility of integrating neural mobilization techniques into a multimodal physical exercise program for older adults with chronic musculoskeletal pain. The main questions it aims to answer are:

* What is the average time to assess secondary outcomes for each participant? * What proportion of participants adhered and/or withdrew from the study at the end of the intervention protocol? * Are there adverse events/effects associated with the intervention protocol? * What is the level of approval/satisfaction of the participants in relation to the assessment and intervention protocols? * What is the impact of the intervention protocol on participants´ pain, function, physical performance, somatosensory function, and nerve excursion (secondary outcomes)?

Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (8 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program (with or without integration of neural mobilization techniques) to be carried out over a period of 8 weeks at a frequency of twice a week.

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Key information

Conditions

Chronic Musculoskeletal Pain Chronic Musculoskeletal Disease Chronic Pain Neurologic Manifestations Older Adults Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aveiro

Aveiro, 3810-193, Portugal

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Individuals with post-surgical pain as a result of surgery performed in the last 6 months;
  • Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, neurodegenerative diseases, 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.

Treatment and study plan

Physical exercise program

Other

The physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises.

Neural Mobilization

Other

Neural mobilization techniques for the upper and lower quadrants will be actively performed by participants.

Other names: Neurodynamics

Primary outcomes

  1. Dropout and adherence rates

    Time frame: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Proportion of participants who adhered and withdrew from the study at the end of the intervention protocol. "Adherence to treatment" will be considered if the participant attends at least 12 sessions (75% of the total scheduled sessions).

  2. Adverse events and adverse effects

    Time frame: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Proportion of participants that reported adverse events and adverse effects during the intervention protocol.

  3. Practicality

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    The average time taken to assess secondary outcomes for each participant.

  4. Acceptability

    Time frame: T1: 8 weeks (post-intervention assessment)

    The degree to which participants approve of or are satisfied with the assessment and intervention protocols. Acceptability will be assessed qualitatively through focus groups, where a recorded interview (audio only) will be carried out by the study's main researcher, in order to assess the participants' perception of the study and the intervention protocol.

Secondary outcomes

  1. Pain severity

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Brief Pain Inventory (BPI)

  2. Temporal characteristics of pain

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    World Health Organization (WHO) Classification - It is a categorical variable with three different possible response categories:

    • Episodic recurrent pain - recurrent pain attacks with pain-free intervals;
    • Continuous pain - pain is always present;
    • Continuous with pain attacks - recurrent pain flare-ups as exacerbations of ongoing underlying pain.

  3. Neuropathic pain components

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    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.

  4. Pain Catastrophizing

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    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.

  5. Fear of Movement

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    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.

  6. Symptoms of Central Sensitization

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Central Sensitization Inventory (CSI)

  7. Pressure Pain Threshold (Thenar region of the right hand; Right calcaneus; Region of greatest pain)

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Algometer

  8. Cold and Warm Perception Threshold ((Thenar region of the right hand; Right calcaneus; Region of greatest pain)

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Q-sense

  9. Lower Limb Strength

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Five Times Sit to Stand Test

  10. Grip Strength

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Hand-held dynamometer

  11. Agility and Dynamic Balance

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Timed-Up-And-Go Test

  12. Nerve excursion (median and tibial nerves)

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Ultrasonography - The longitudinal and transverse excursion of the tibial and median nerves will be measured in millimeters using ultrasound images taken during the execution of a joint movement.

  13. Range of Motion (ankle dorsiflexion and wrist extension)

    Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

    Goniometer

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

A Feasibility and Acceptability Study of a Physical Exercise Program Including Neural Mobilization to Improve Pain, Functional Status, and Physical Performance in Older Adults With Chronic Musculoskeletal Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jul 16, 2024

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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