The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly

NCT ID: NCT05475652

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2022-12-31

Brief Summary

Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

Detailed Description

The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.

To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.

Conditions

Balance, Postural; Gait; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sham (ligth touch)

Placebo intervention composed of light touch treatment on the cervical spine.

Group Type: SHAM_COMPARATOR

Placebo intervention

Intervention Type: OTHER

The Sham group receives placebo treatment twice (D0 and D7). This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy. Outcomes are evaluation before and after placebo intervention. The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group

Manual therapy

Manual therapy applied to the cervical spine.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

The manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7). This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine. Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses. Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7. On D21, only one assessment will be done at the beginning of the session.

Interventions

Manual therapy

The manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7). This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine. Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses. Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7. On D21, only one assessment will be done at the beginning of the session.

Intervention Type: OTHER

Placebo intervention

The Sham group receives placebo treatment twice (D0 and D7). This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy. Outcomes are evaluation before and after placebo intervention. The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 65 years of age or older, of either sex
• Autonomous, able to walk ten meters alone without walking aid
• Able to understand instructions necessary for the correct performance of the measurements.

Exclusion Criteria

• Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
• Patient who has an history of surgery - fracture - dislocation of the cervical spine
• Patient who has cognitive impairments (Mini Mental Statement <20)
• Patient who has life expectancy less than 6 months.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EZUS-LYON 1

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurianne PINLOCHE, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratoire Interuniversitaire de Biologie de la Motricité

Locations

Hôpital de la Croix-Rousse

Lyon, Rhône, France

Countries

France

References

Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.

Reference Type: DERIVED

PMID: 36045446 (View on PubMed)

Other Identifiers

002B2019

Identifier Type: -

Identifier Source: org_study_id