Foot Reflexology Therapy and Non-specific Low Back Pain

Early Phase 1

• Conditions: Low Back Pain
• Interventions: Other: foot reflexology therapy

• Registration Number: NCT02887430
• Lead Sponsor: Universiti Sultan Zainal Abidin

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.

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-29
• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Posted: 2016-09-02
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-08
• Primary Completion: 2016-10
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	foot reflexology therapy	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

Primary Outcome Measures

Name	Time	Method
mean time in days to the recovery of pain	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)

Secondary Outcome Measures

Name	Time	Method
demographic information	3 month	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	5 month	reporting of possible side effects of the treatment, both reflexology and medication
health-related quality of life	5 months	measuring mean of health-related quality of life using Euro-quality of life 5D questionnaire before and after intervention