- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449819
Neural Mobilization to Improve Chronic Musculoskeletal Pain in Older Adults
Neural Mobilization in the Treatment of Chronic Musculoskeletal Pain in Older Adults: A Single-Case Experimental Design Study.
The goal of this clinical trial is to discover whether performing active neural mobilization exercises works to manage chronic musculoskeletal pain in older adults. The main question it aims to answer is:
Can an active neural mobilization program improve pain intensity and functional capacity?
Participants will:
- Perform active neural mobilization exercises for 8 weeks (twice a week), under the in-person supervision of a physiotherapist;
- Visit the clinic twice a week for 9 to 12 weeks for consultations, examinations, and symptom monitoring;
- Keep a diary of their symptoms and frequency of analgesic use.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aveiro, Portugal, 3810-193
- Department of Medical Sciences, University of Aveiro (Portugal)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Community-dwelling older adults aged 60 years or older
- People with chronic musculoskeletal pain
Exclusion Criteria:
- Individuals undergoing surgery in the last 3 months
- Individuals diagnosed with dementia, cancer, thrombosis, or central nervous system injury (e.g., stroke);
- Individuals who are receiving another physiotherapy intervention
- Individuals who do not understand the Portuguese language
- Individuals with mild cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active Neural Mobilization Exercises
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Participants will actively perform neural mobilization exercises for the upper and lower limbs, as well as spinal structures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain diary
Time Frame: Every day (until the end of the study) - from week 1 to week 21
|
Participants will be asked to complete a daily "pain diary," recording:
|
Every day (until the end of the study) - from week 1 to week 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain distribution
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
A body chart to record the location and distribution of pain.
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
|
Neuropathic pain components
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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.
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
|
Pain Catastrophizing
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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.
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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Kinesiophobia
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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.
|
Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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Signs and symptoms of hypersensitivity of the nervous system
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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.
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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Balance
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
Functional Reach Test
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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Lower Limb Strength
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
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Five Times Sit to Stand Test
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
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Grip Strength
Time Frame: Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
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Hand-held dynamometer
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Three assessment points: 1) Baseline 2) At the end of the intervention program 3) At the end of the study (week 21)
|
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Range of motion of wrist extension and tibiotarsal movements
Time Frame: Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
Measured with a manual goniometer
|
Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
|
Excursion of the median and fibular nerves
Time Frame: Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
Measured by ultrasound
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Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
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Pressure Pain Threshold measured in three different sites (thenar region of the hand; dorsum of foot; region of greatest pain)
Time Frame: Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
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Measured with an algometer
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Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
|
Q-sense - Cold and Warm Perception Threshold (thenar region of the hand; dorsum of foot; region of greatest pain)
Time Frame: Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
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).
|
Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
|
Q-sense - Heat Pain Threshold (thenar region of the hand; dorsum of foot; region of greatest pain)
Time Frame: Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
It will be assessed using a portable quantitative sensory testing device capable of assessing peripheral sensory nerve function (Q-sense, Medoc).
|
Measured from week 1 to week 9-12 (twice a week). Considering that participants will have different baseline durations and the same intervention duration (8 weeks), the assessment of this outcome can be done up to week 9, 10, 11, or 12.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCED1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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