Clinical trial NCT06138314: A Pilot Study of a Neural Mobilization Intervention Applied to Older Adults With Chronic Musculoskeletal Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Chronic Pain
Chronic Musculoskeletal Disease
Older Adults
Keywords: elderly
physical therapy
neural mobilization
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dropout and adherence rates
timeFrame: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Adverse events and adverse effects
timeFrame: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Practicality
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Acceptability
timeFrame: T1: 8 weeks (post-intervention assessment)
Secondary outcomes:
measure: Pain severity
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Temporal characteristics of pain
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Neuropathic pain components
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Pain Catastrophizing
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Fear of Movement
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Symptoms of Central Sensitization
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Pressure Pain Threshold (Thenar region of the right hand; Right calcaneus; Region of greatest pain)
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Cold and Warm Perception Threshold ((Thenar region of the right hand; Right calcaneus; Region of greatest pain)
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Lower Limb Strength
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Grip Strength
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Agility and Dynamic Balance
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Nerve excursion (median and tibial nerves)
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Range of Motion (ankle dorsiflexion and wrist extension)
timeFrame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
References: