Foot Reflexology Therapy and Non-specific Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: foot reflexology therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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 | Other: foot reflexology therapy<br>* standard care and foot reflexology<br>|
| No Intervention: control<br>participants will be received standard care in general practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 month | 
| side effects of treatment | reporting of possible side effects of the treatment, both reflexology and medication | 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 | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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foot reflexology, pain intensity, health-related quality of life