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

NCT06138314 | Completed

• 1 other identifier: RCT1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain; Chronic Pain; Chronic Musculoskeletal Disease; Older Adults

Keywords

elderly; physical therapy; neural mobilization

Outcome Measures

Primary Outcomes (4)

• Dropout and adherence rates

  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).

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

• Adverse events and adverse effects

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

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

• Practicality

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

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

• Acceptability

  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.

  T1: 8 weeks (post-intervention assessment)

Secondary Outcomes (13)

• Pain severity

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

• Temporal characteristics of pain

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

• Neuropathic pain components

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

• Pain Catastrophizing

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

• Fear of Movement

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group will perform a physical exercise program twice a week for a period of 8 weeks.

Other: Physical Exercise Program

Experimental group

EXPERIMENTAL

The experimental group will perform the same physical exercise program performed by participants in the control group, in addition to neural mobilization techniques twice a week for a period of 8 weeks.

Other: Physical Exercise Program; Other: Neural Mobilization

Interventions

Physical Exercise Program OTHER

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

Control group; Experimental group

Neural Mobilization OTHER

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

Also known as: Neurodynamics

Experimental group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: February 12, 2024
• Primary Completion: April 12, 2024
• Study Completion: July 13, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

PT (1)