Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics

NCT05085535 | Withdrawn

• 1 other identifier: TM-ET
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 on the contrary, do not significantly modify the effect of exercise programs.

Conditions

Pain; Disability Physical; Aging Disorder

Keywords

Therapeutic exercise,; manual therapy,; elderly,; geriatrics,; pain,; disability.

Outcome Measures

Primary Outcomes (3)

• Change of subjective assessment of pain intensity

  using a VAS TEST (Visual Analog Score for pain) (Minimum = 0 better and maximum = 10 worse)

  beginning and through study completion, an average of 12 weeks

• Change of the qualitative aspects of pain

  using the McGill pain questionnary

  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)

  beginning and through study completion, an average of 12 weeks

Secondary Outcomes (2)

• Change of risk of falls

  beginning and through study completion, an average of 12 weeks

• Change of Physical activity in older adults

  beginning and through study completion, an average of 12 weeks

Study Arms (2)

Exercise

ACTIVE COMPARATOR

to which the treatment of therapeutic exercise and pain education will be applied,

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.

Other: Manual Therapy

Interventions

Manual Therapy OTHER

Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy

Manual Therapy

Exercise OTHER

Exercises for body mobility and muscle toning, Sophrology

Exercise

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Juan Vicente, López Díaz: lead
• Omphis Foundation: collaborator

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan Vicente López Díaz

  Fundación Omphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A triple blinding will be carried out: 1) of the patient, 2) of the collaborator who performs the data collection, 3) of the computer data analyst. The physiotherapist who performs the intervention of manual therapy, exercise teaching and pain education, it is impossible to blind him.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: It is a study of the randomized clinical trial

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 20, 2021
• Study Start: June 8, 2024
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share