PainNCT05085535
Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics
A study testing Manual Therapy and Exercise in people with Pain and Disability Physical, run by Juan Vicente, López Díaz.
Trial summary
This research project is part of the process of generating scientific evidence, on whether the clinical results obtained, in the treatment of the consequences of aging on mobility, pain and disability, are better if therapeutic exercise programs are added sessions of manual therapy and training in pain awareness, or… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Disability Physical, Aging Disorder
- What is being tested?
- Manual Therapy and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2024to 30 Dec 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People of both sexes.
- Between 65 and 85 years of age.
- No acute pathologies at the time of selection.
- Who present symptoms of muscle-joint degenerative mechanical aging with an intensity score greater than 4 on a scale of 0-10.
Who cannot join
- Patients with a recent traumatic history.
- Presence of an acute-type radiation component of neurological origin to upper or lower limbs.
- With neurological alterations both central and peripheral.
- Who are taking opioid-based analgesic medication, gabapentin, etc.
- Patients with severe malformations.
- Who are following any other type of treatment, be it manual or physical agents or alternative or complementary therapies.
Show all 11Show fewer
- Those who have been treated with infiltrations or the like in a period of less than a year before starting the study.
- Patients with a serious psychiatric history such as schizophrenia or psychopathies.
- Patients with cognitive impairment.
- Patients with vestibular problems that cannot tolerate oscillatory movements.
- Those who are contraindicated due to their general metabolic or cardiopulmonary state to carry out moderate physical exercise.
About this study
Official title: Study of the Effect of Adding Manual Therapy to Therapeutic Exercise Programs in Older Adults With Limited Mobility and Pain Secondary to Aging.
This research project is part of the process of generating scientific evidence, on whether the clinical results obtained, in the treatment of the consequences of aging on mobility, pain and disability, are better if therapeutic exercise programs are added sessions of manual therapy and training in pain awareness, or on the contrary, do not significantly modify the effect of exercise programs.
Read the detailed description
General objective:
Find out if adding Manual Therapy (MT) sessions to therapeutic exercise programs increases the efficacy of clinical results for the treatment of ailments derived from aging in older adults (65 <age <85).
Specific objectives:
- Assess the effects on pain. (hypothesis: MT improves pain outcomes)
- Assess the effects on physical disability. (hypothesis: MT improves results regarding physical disability)
- Assess the effects on mental disability. (hypothesis: MT improves results regarding mental disability)
- Assess the effects on the prevention of falls (hypothesis: MT improves the results regarding the risk of falls)
Methodology:
Study design: It is a study of the randomized clinical trial type, with triple blind.
Selection of participants:
- General criteria:
- The sample will be selected from the patients who volunteer to participate in the study, which will be announced by the media (Radio and / or TV) and meet the inclusion criteria and not the exclusion criteria.
- Participants will be treated by different therapists, who will be instructed in the treatments to be performed on the participants, to eliminate the therapist's personal factor as a contaminating variable.
- Participants will be referred to the physiotherapist according to the group assigned by the randomization process, which will be unknown by the patient.
Sample size:
To calculate the sample size, the EPIDAT 4.2 or GRANMO 7.12 computer program will be used, depending on the population and epidemiological data of the Catalunya area, of older adults, with disabilities and mechanical-degenerative pain.
If the calculation is made based on a Student's t test for independent data, accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 25 subjects would be required in each group to detect a minimum difference of 20 percentage points. between two groups, assuming a common standard deviation of 25 points, and a loss to follow-up rate of 0%, following the usual criteria of biostatistics in health sciences (1) and the criteria of minimal differences between groups previously used in similar pilot studies.
In case of loss of subjects in the sample, participants should be replaced by others to maintain proportions. The definitive calculations will be made with more precision after the epidemiological study mentioned above.
Randomization Of all the participants who meet the inclusion criteria and do not have any exclusion criteria, a number will be assigned, after being randomized through a computerized process, to distribute each number to the corresponding group. The patient will not know which group he has been assigned to.
Analytical procedure:
Analysis by computer processing with SPSS 22.0 ® program. Performed by a blinded computer analyst.
Ethical aspects:
During the study, national and international guidelines (code of ethics, Declaration of Helsinki) will be followed, as well as the legal regulations on data confidentiality (Organic Law 3/2018 of December 5 on the Protection of Personal Data and guarantee of digital rights -LOPD-).
- Conditions
- Pain, Disability Physical, Aging Disorder
- Being tested
- Manual Therapy, Exercise
- Keywords
- Therapeutic exercise,, manual therapy,, elderly,, geriatrics,, pain,, disability.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy
ExerciseOther
Exercises for body mobility and muscle toning, Sophrology
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | to which the treatment of therapeutic exercise and pain education will be applied, Receives: Other: Exercise |
| Manual Therapy | Experimental | to which the same treatment as the control group will be applied, adding manual therapy sessions based on musculoskeletal rhythmic mobilizations. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subjective assessment of pain intensity
using a VAS TEST (Visual Analog Score for pain) (Minimum = 0 better and maximum = 10 worse)
Measured: beginning and through study completion, an average of 12 weeks
Change of the qualitative aspects of pain
using the McGill pain questionnary
Measured: beginning and through study completion, an average of 12 weeks
Change of of disability and health status
using the SF36 test (36-item short form health survey)
Measured: beginning and through study completion, an average of 12 weeks
Secondary outcomes (2)
Change of risk of falls
Tinetti test. (test for balance and gait) (Minimum = 0 worse and maximum = 28 better)
Measured: beginning and through study completion, an average of 12 weeks
Change of Physical activity in older adults
PASE test (Physical Activity Scale for the Elderly)
Measured: beginning and through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Jun 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Not enough participants were recruited for a quality study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- It is a study of the randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Vicente, López Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Omphis Foundation
- Responsible party
- Sponsor-investigator, Juan Vicente, López Díaz, Omphis Foundation
- Investigators
- Juan Vicente López Díaz, Principal investigator, Fundación Omphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085535
- Sponsor's protocol ID
- TM-ET
- Status last verified
- Jun 2025
- First submitted
- 21 Sep 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Adding Manual Therapy to Therapeutic Exercise Programs in Older Adults With Limited Mobility and Pain Secondary to Aging.
- ClinicalTrials.gov ID
- NCT05085535
- Acronym / sponsor ID
- TM-ET
- Conditions
- Pain, Disability Physical, Aging Disorder
- Keywords
- Therapeutic exercise,, manual therapy,, elderly,, geriatrics,, pain,, disability.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants were recruited for a quality study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juan Vicente, López DíazUniversity, hospital or other
- Collaborators
- Omphis Foundation
- Study start
- 8 Jun 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Oct 2021 (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.
This research project is part of the process of generating scientific evidence, on whether the clinical results obtained, in the treatment of the consequences of aging on mobility, pain and disability, are better if therapeutic exercise programs are added sessions of manual therapy and training in pain awareness, or on the contrary, do not significantly modify the effect of exercise programs.
Detailed description
General objective:
Find out if adding Manual Therapy (MT) sessions to therapeutic exercise programs increases the efficacy of clinical results for the treatment of ailments derived from aging in older adults (65 <age <85).
Specific objectives:
- Assess the effects on pain. (hypothesis: MT improves pain outcomes)
- Assess the effects on physical disability. (hypothesis: MT improves results regarding physical disability)
- Assess the effects on mental disability. (hypothesis: MT improves results regarding mental disability)
- Assess the effects on the prevention of falls (hypothesis: MT improves the results regarding the risk of falls)
Methodology:
Study design: It is a study of the randomized clinical trial type, with triple blind.
Selection of participants:
- General criteria:
- The sample will be selected from the patients who volunteer to participate in the study, which will be announced by the media (Radio and / or TV) and meet the inclusion criteria and not the exclusion criteria.
- Participants will be treated by different therapists, who will be instructed in the treatments to be performed on the participants, to eliminate the therapist's personal factor as a contaminating variable.
- Participants will be referred to the physiotherapist according to the group assigned by the randomization process, which will be unknown by the patient.
Sample size:
To calculate the sample size, the EPIDAT 4.2 or GRANMO 7.12 computer program will be used, depending on the population and epidemiological data of the Catalunya area, of older adults, with disabilities and mechanical-degenerative pain.
If the calculation is made based on a Student's t test for independent data, accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 25 subjects would be required in each group to detect a minimum difference of 20 percentage points. between two groups, assuming a common standard deviation of 25 points, and a loss to follow-up rate of 0%, following the usual criteria of biostatistics in health sciences (1) and the criteria of minimal differences between groups previously used in similar pilot studies.
In case of loss of subjects in the sample, participants should be replaced by others to maintain proportions. The definitive calculations will be made with more precision after the epidemiological study mentioned above.
Randomization Of all the participants who meet the inclusion criteria and do not have any exclusion criteria, a number will be assigned, after being randomized through a computerized process, to distribute each number to the corresponding group. The patient will not know which group he has been assigned to.
Analytical procedure:
Analysis by computer processing with SPSS 22.0 ® program. Performed by a blinded computer analyst.
Ethical aspects:
During the study, national and international guidelines (code of ethics, Declaration of Helsinki) will be followed, as well as the legal regulations on data confidentiality (Organic Law 3/2018 of December 5 on the Protection of Personal Data and guarantee of digital rights -LOPD-).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a study of the randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: Exerciseto which the treatment of therapeutic exercise and pain education will be applied, |
| Manual Therapy | Experimental | Other: Manual Therapyto which the same treatment as the control group will be applied, adding manual therapy sessions based on musculoskeletal rhythmic mobilizations. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People of both sexes.
- Between 65 and 85 years of age.
- No acute pathologies at the time of selection.
- Who present symptoms of muscle-joint degenerative mechanical aging with an intensity score greater than 4 on a scale of 0-10.
Key exclusion criteria (11 listed)
- Patients with a recent traumatic history.
- Presence of an acute-type radiation component of neurological origin to upper or lower limbs.
- With neurological alterations both central and peripheral.
- Who are taking opioid-based analgesic medication, gabapentin, etc.
- Patients with severe malformations.
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 |
|---|---|---|
| Manual TherapyExercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy | Other | Manual Therapy |
| ExerciseExercises for body mobility and muscle toning, Sophrology | Other | Exercise |
Primary outcome
Change of subjective assessment of pain intensity
Time frame: beginning and through study completion, an average of 12 weeks
using a VAS TEST (Visual Analog Score for pain) (Minimum = 0 better and maximum = 10 worse)
Change of the qualitative aspects of pain
Time frame: beginning and through study completion, an average of 12 weeks
using the McGill pain questionnary
Change of of disability and health status
Time frame: beginning and through study completion, an average of 12 weeks
using the SF36 test (36-item short form health survey)
2 secondary outcomes
Change of risk of falls
Time frame: beginning and through study completion, an average of 12 weeks
Change of Physical activity in older adults
Time frame: beginning and through study completion, an average of 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Juan Vicente López Díaz principal investigator
Fundación Omphis
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise in people with Pain and Disability Physical, run by Juan Vicente, López Díaz.
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change of subjective assessment of pain intensity (time frame: beginning and through study completion, an average of 12 weeks). The study lists 3 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 29 Jun 2025.