Trial Outcomes & Findings for Foot Orthoses and Elderly Women With Osteoporosis (NCT NCT01508169)

Results Overview

The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

4 weeks

Results posted on

2012-04-06

Participant Flow

From April 2011 to October 2011, patients in treatment in the outpatient clinic of the Rheumatology Division of Unicamp, who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assessed.

From the 242 patients considered eligible, 148 were not included due exclusing criteria (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, previous foot surgery, inability to attend the reevaluations).

Participant milestones

Participant milestones
Measure	Foot Orthosis 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. Fourty-four subjects completed the protocol.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.	Control Group 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. Fourty-five subjects completed the protocol. 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.
Overall Study STARTED	47	47
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Foot Orthosis 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. Fourty-four subjects completed the protocol.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.	Control Group 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. Fourty-five subjects completed the protocol. 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.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Foot Orthoses and Elderly Women With Osteoporosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foot Orthosis n=47 Participants 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. Fourty-four subjects completed the protocol.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.	Control Group n=47 Participants 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. Fourty-five subjects completed the protocol. 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.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Age Continuous	72.38 years STANDARD_DEVIATION 6.83 • n=5 Participants	72.04 years STANDARD_DEVIATION 7.14 • n=7 Participants	72.38 years STANDARD_DEVIATION 6.83 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	47 participants n=5 Participants	47 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.

The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.

Outcome measures

Outcome measures
Measure	Foot Orthosis n=44 Participants Fourty-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. Fourty-four subjects completed the protocol. 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.	Control Group n=45 Participants 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. Fourty-five subjects complited the protocolBalance, 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.
Berg Balance Scale (BBS)	50.68 scores on a scale Standard Deviation 4.18	43.13 scores on a scale Standard Deviation 6.24

PRIMARY outcome

Timeframe: 4 weeks

Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.

The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.

Outcome measures

Outcome measures
Measure	Foot Orthosis n=44 Participants Fourty-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. Fourty-four subjects completed the protocol. 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.	Control Group n=45 Participants 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. Fourty-five subjects complited the protocolBalance, 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.
Timed up and Go Test (TUG)	11.97 seconds Standard Deviation 2.80	15.82 seconds Standard Deviation 3.23

SECONDARY outcome

Timeframe: 4 weeks

Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.

Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)

Outcome measures

Outcome measures
Measure	Foot Orthosis n=44 Participants Fourty-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. Fourty-four subjects completed the protocol. 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.	Control Group n=45 Participants 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. Fourty-five subjects complited the protocolBalance, 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.
Numeric Pain Scale	1.68 units on a scale Standard Deviation 2.46	4.20 units on a scale Standard Deviation 3.07

SECONDARY outcome

Timeframe: 4 weeks

Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.

The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase "Because of pain in my feet…", organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: "none of the time" (score = 0), "some days" (score = 1), and "most days/every day" (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability.

Outcome measures

Outcome measures
Measure	Foot Orthosis n=44 Participants Fourty-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. Fourty-four subjects completed the protocol. 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.	Control Group n=45 Participants 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. Fourty-five subjects complited the protocolBalance, 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.
Manchester Foot and Pain Disability Index(MFPDI)	11.48 scores on a scale Standard Deviation 5.56	22.64 scores on a scale Standard Deviation 9.20

Adverse Events

Foot Orthosis

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Foot Orthosis n=47 participants at risk 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. Fourty-four subjects completed the protocol.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.	Control Group 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. Fourty-five subjects completed the protocol. 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.
Musculoskeletal and connective tissue disorders foot discomfort	4.3% 2/47 • Number of events 2 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.	— 0/0 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.
Musculoskeletal and connective tissue disorders feet heat	4.3% 2/47 • Number of events 2 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.	— 0/0 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.
Musculoskeletal and connective tissue disorders tightness of footwear	4.3% 2/47 • Number of events 2 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.	— 0/0 • The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.

Additional Information

Cecilia de Morais Barbosa

Hospital de Clinicas da Universidade Estadual de Campinas (Unicamp)

Phone: +55-19-35217113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place