Back to resultsFoot Reflexology Therapy and Non-specific Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
foot reflexology therapy
Sponsored by
About this trial
This is an interventional screening trial for Low Back Pain focused on measuring foot reflexology, pain intensity, health-related quality of life
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
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
participants will be received standard care in general practice
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
side effects of treatment
reporting of possible side effects of the treatment, both reflexology and medication
health-related quality of life
measuring mean of health-related quality of life using Euro-quality of life 5D questionnaire before and after intervention
Full Information
NCT ID
NCT02887430
First Posted
August 19, 2016
Last Updated
September 6, 2016
Sponsor
Universiti Sultan Zainal Abidin
1. Study Identification
Unique Protocol Identification Number
NCT02887430
Brief Title
Foot Reflexology Therapy and Non-specific Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sultan Zainal Abidin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
foot reflexology, pain intensity, health-related quality of life
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
participants will be received standard care in general practice
Intervention Type
Other
Intervention Name(s)
foot reflexology therapy
Intervention Description
standard care and foot reflexology
Primary Outcome Measure Information:
Title
mean time in days to the recovery of pain
Description
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)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
demographic information
Description
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.
Time Frame
3 month
Title
side effects of treatment
Description
reporting of possible side effects of the treatment, both reflexology and medication
Time Frame
5 month
Title
health-related quality of life
Description
measuring mean of health-related quality of life using Euro-quality of life 5D questionnaire before and after intervention
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Foot Reflexology Therapy and Non-specific Low Back Pain
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