Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics

Pain Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05085535
• Other study ID #: TM-ET
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 8, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Omphis Foundation
• Contact: Juan Vicente López Díaz, Doctor
• Phone: +34609724888
• Email: juanlopez[@]pold.es
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aging Disorder
• Disability Physical
• Pain

Intervention

Other:
• Manual Therapy
Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy
• Exercise
Exercises for body mobility and muscle toning, Sophrology

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
JUAN V. LOPEZ DIAZ	Omphis Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of the qualitative aspects of pain	using the McGill pain questionnary	beginning and through study completion, an average of 12 weeks
Primary	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	Change of risk of falls	Tinetti test. (test for balance and gait) (Minimum = 0 worse and maximum = 28 better)	beginning and through study completion, an average of 12 weeks
Secondary	Change of Physical activity in older adults	PASE test (Physical Activity Scale for the Elderly)	beginning and through study completion, an average of 12 weeks