Chronic Musculoskeletal PainNCT06138314
A Pilot Study of a Neural Mobilization Intervention Applied to Older Adults With Chronic Musculoskeletal Pain
A study testing Physical Exercise Program and Neural Mobilization in people with Chronic Musculoskeletal Pain and Chronic Pain, run by Aveiro University at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Chronic Pain, Chronic Musculoskeletal Disease
- What is being tested?
- Physical Exercise Program and Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Feb 2024to 13 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Physical Exercise Program, Neural Mobilization
- Keywords
- elderly, physical therapy, neural mobilization
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise ProgramOther
The physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises.
Neural MobilizationOther
Also called Neurodynamics
Neural mobilization techniques for the upper and lower quadrants will be actively performed by participants.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will perform a physical exercise program twice a week for a period of 8 weeks. Receives: 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. Receives: Other: Physical Exercise Program; Other: Neural Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1: 8 weeks (post-intervention assessment)
Secondary outcomes (13)
Pain severity
Brief Pain Inventory (BPI)
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Temporal characteristics of pain
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.
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Neuropathic pain components
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.
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Pain Catastrophizing
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.
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Fear of Movement
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.
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Symptoms of Central Sensitization
Central Sensitization Inventory (CSI)
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Pressure Pain Threshold (Thenar region of the right hand; Right calcaneus; Region of greatest pain)
Algometer
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Cold and Warm Perception Threshold ((Thenar region of the right hand; Right calcaneus; Region of greatest pain)
Q-sense
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Lower Limb Strength
Five Times Sit to Stand Test
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Grip Strength
Hand-held dynamometer
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Agility and Dynamic Balance
Timed-Up-And-Go Test
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Nerve excursion (median and tibial nerves)
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.
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Range of Motion (ankle dorsiflexion and wrist extension)
Goniometer
Measured: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start12 Feb 2024
- Primary completion12 Apr 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Mesquita Baptista, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138314
- Sponsor's protocol ID
- RCT1
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06138314
- Acronym / sponsor ID
- RCT1
- Keywords
- elderly, physical therapy, neural mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Physical Exercise ProgramThe control group will perform a physical exercise program twice a week for a period of 8 weeks. |
| Experimental group | Experimental | Other: Physical Exercise Program, Other: Neural MobilizationThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise ProgramThe physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises. | Other | Control group, Experimental group |
| Neural MobilizationAlso: NeurodynamicsNeural mobilization techniques for the upper and lower quadrants will be actively performed by participants. | Other | Experimental group |
Primary outcome
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).
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.
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.
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.
13 secondary outcomes
Pain severity
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Temporal characteristics of pain
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Neuropathic pain components
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Pain Catastrophizing
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Fear of Movement
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Symptoms of Central Sensitization
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
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)
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)
Lower Limb Strength
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Grip Strength
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Agility and Dynamic Balance
Time frame: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Program and Neural Mobilization in people with Chronic Musculoskeletal Pain and Chronic Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout and adherence rates (time frame: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.