Non-specific Pain in Lower ExtremitiesNCT01640899
Insoles Effect on Pain and Daily Activities
A study testing Shoe Insoles in people with Non-specific Pain in Lower Extremities, run by Centre for Rehabilitation Research, Örebro at 1 site in Sweden.
Trial summary
The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Pain in Lower Extremities
- What is being tested?
- Shoe Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in lower extremities
- Aged 18 years or older
- Able to speak Swedish.
Who cannot join
- Pain due to a systemic or progressive disease
- Use of orthosis of other type than insoles
- Earlier foot surgery or current use of prosthesis.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Prosthetics and Orthotics, Orebro University Hospital
Örebro, Örebro County, 701 85
About this study
Official title: The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey
The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.
Read the detailed description
Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.
One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.
Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.
- Conditions
- Non-specific Pain in Lower Extremities
- Being tested
- Shoe Insoles
- Keywords
- Orthotic Devices, Activities of Daily Living, Pain Measurement, Lower Extremity, Foot, Personal Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoe InsolesDevice
Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Other | This is a single-arm study. Just one group (i.e. the patients) Receives: Device: Shoe Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoe insoles effect on pain level in lower extremities.
The participants answer the inetial questioniners before getting the insoles, then answr the same questionnier after four weeks of insoles use.
Measured: Four-weeks follwo up period
Shoe insoles effect on daily activities
The participants answer Inetnational Physical Activty Questionnier (IPAQ)and Lower Extremity Functional Status (LEFS)before getting the insoles and after four weeks of use.
Measured: Four-weeks follow up period
Satisfaction with shoe insoles use
Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.
Measured: After four weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Pain in Lower ExtremitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Rehabilitation Research, Örebro
- Sponsor type
- Other government
- Collaborators
- Örebro County Council
- Responsible party
- Principal investigator, Ahmed Amer, Centre for Rehabilitation Research, Örebro
- Investigators
- Ahmed Amer, Master, Principal investigator, Centre for Rehabilitation Reserach, ÖrebroLiselotte Norling-Hermansson, PhD, Study director, Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640899
- Sponsor's protocol ID
- CRR120709
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey
- ClinicalTrials.gov ID
- NCT01640899
- Acronym / sponsor ID
- CRR120709
- Conditions
- Non-specific Pain in Lower Extremities
- Keywords
- Orthotic Devices, Activities of Daily Living, Pain Measurement, Lower Extremity, Foot, Personal Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre for Rehabilitation Research, ÖrebroOther government
- Collaborators
- Örebro County Council
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.
Detailed description
Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.
One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.
Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Other | Device: Shoe InsolesThis is a single-arm study. Just one group (i.e. the patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain in lower extremities
- Aged 18 years or older
- Able to speak Swedish.
Key exclusion criteria (3 listed)
- Pain due to a systemic or progressive disease
- Use of orthosis of other type than insoles
- Earlier foot surgery or current use of prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoe InsolesShoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment. | Device | Single-arm study |
Primary outcome
Shoe insoles effect on pain level in lower extremities.
Time frame: Four-weeks follwo up period
The participants answer the inetial questioniners before getting the insoles, then answr the same questionnier after four weeks of insoles use.
Shoe insoles effect on daily activities
Time frame: Four-weeks follow up period
The participants answer Inetnational Physical Activty Questionnier (IPAQ)and Lower Extremity Functional Status (LEFS)before getting the insoles and after four weeks of use.
Satisfaction with shoe insoles use
Time frame: After four weeks of use
Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Information about the study (In Swedish)Link provided by the sponsor.
- Main page of Centre for Rehabilitation ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Amer, Master principal investigator
Centre for Rehabilitation Reserach, Örebro
Liselotte Norling-Hermansson, PhD study director
Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoe Insoles in people with Non-specific Pain in Lower Extremities, run by Centre for Rehabilitation Research, Örebro at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoe insoles effect on pain level in lower extremities. (time frame: Four-weeks follwo up period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.