Foot Orthoses and Elderly Women With Osteoporosis

University of Campinas, Brazil

Status: Completed

Conditions: Osteoporosis

Treatments: Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01508169

UNICAMP-REUMATO 01

Details and patient eligibility

About

The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.

Full description

Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.

Enrollment: 94 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of osteoporosis

Exclusion criteria

• reduced tactile and thermal foot sensibility
• compromised skin integrity of the lower limbs
• autoimmune rheumatic diseases
• vestibular symptoms
• central nervous system pathologies
• peripheral neuropathy
• use of insoles in the last month
• lower limb prostheses
• previous history of foot surgery
• amputation of the lower limbs
• inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Foot orthosis

Experimental group

Description:

Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.

Treatment:

Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)

Control Group

No Intervention group

Description:

Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.