Low Back PainEarly Phase 1NCT02887430
Foot Reflexology Therapy and Non-specific Low Back Pain
A Early Phase 1 study testing foot reflexology therapy in people with Low Back Pain, run by Universiti Sultan Zainal Abidin.
Trial summary
The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- foot reflexology therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 2017
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have been medically diagnosed with a non-specific low back pain.
- Have not received treatment for low back pain within the previous 2 weeks.
- Are at least 18 years old.
- Have both feet and all toes intact and free from wounds.
- Have not undergone any other complementary and alternative therapies during the study.
Who cannot join
- Have severe coexistent disease and serious pathology or systemic illness.
- Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).
- Have plantar fasciitis.
- Lack the ability to read and write Malaysia language.
- Had plans to move out of the area.
About this study
Official title: The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain
The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.
Read the detailed description
Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.
- Conditions
- Low Back Pain
- Being tested
- foot reflexology therapy
- Keywords
- foot reflexology, pain intensity, health-related quality of life
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexology therapyOther
standard care and foot reflexology
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Participants will be received 8 sessions of foot reflexology therapy, 30 minutes each (2 sessions per week of 4 weeks) and low back pain standard care Receives: Other: foot reflexology therapy |
| control | No intervention | participants will be received standard care in general practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean time in days to the recovery of pain
the mean time in days to the recovery of pain is measured at the first day the patient scores 0 to 10 point on the visual analog scale (VAS)
Measured: 5 months
Secondary outcomes (3)
demographic information
demographic information including age, ethnicity, marital status, educational level, weight, height, household monthly income, smoking status, alcohol consumption, co-morbid disease and categories of low back pain.
Measured: 3 month
side effects of treatment
reporting of possible side effects of the treatment, both reflexology and medication
Measured: 5 month
health-related quality of life
measuring mean of health-related quality of life using Euro-quality of life 5D questionnaire before and after intervention
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sultan Zainal Abidin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nor dalila marican, Universiti Sultan Zainal Abidin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887430
- Sponsor's protocol ID
- UHREC/2016/2/011
- Status last verified
- Sep 2016
- First submitted
- 19 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT02887430
- Acronym / sponsor ID
- UHREC/2016/2/011
- Conditions
- Low Back Pain
- Keywords
- foot reflexology, pain intensity, health-related quality of life
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiti Sultan Zainal AbidinUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 2 Sep 2016 (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 aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.
Detailed description
Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: foot reflexology therapyParticipants will be received 8 sessions of foot reflexology therapy, 30 minutes each (2 sessions per week of 4 weeks) and low back pain standard care |
| control | No intervention | –participants will be received standard care in general practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been medically diagnosed with a non-specific low back pain.
- Have not received treatment for low back pain within the previous 2 weeks.
- Are at least 18 years old.
- Have both feet and all toes intact and free from wounds.
- Have not undergone any other complementary and alternative therapies during the study.
Key exclusion criteria (5 listed)
- Have severe coexistent disease and serious pathology or systemic illness.
- Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).
- Have plantar fasciitis.
- Lack the ability to read and write Malaysia language.
- Had plans to move out of the area.
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 |
|---|---|---|
| foot reflexology therapystandard care and foot reflexology | Other | intervention |
Primary outcome
mean time in days to the recovery of pain
Time frame: 5 months
the mean time in days to the recovery of pain is measured at the first day the patient scores 0 to 10 point on the visual analog scale (VAS)
3 secondary outcomes
demographic information
Time frame: 3 month
side effects of treatment
Time frame: 5 month
health-related quality of life
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing foot reflexology therapy in people with Low Back Pain, run by Universiti Sultan Zainal Abidin.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
mean time in days to the recovery of pain (time frame: 5 months). 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 8 Sep 2016.