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

NCT ID: NCT06138314

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-07-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Physical Exercise Program

Intervention Type: OTHER

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

Experimental group

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.

Group Type: EXPERIMENTAL

Physical Exercise Program

Intervention Type: OTHER

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

Neural Mobilization

Intervention Type: OTHER

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

Interventions

Physical Exercise Program

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

Intervention Type: OTHER

Neural Mobilization

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

Intervention Type: OTHER

Other Intervention Names

Neurodynamics

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aveiro University

OTHER

Sponsor Role: lead

Responsible Party

Frederico Mesquita Baptista

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Aveiro

Aveiro, , Portugal

Countries

Portugal

Other Identifiers

RCT1

Identifier Type: -

Identifier Source: org_study_id